title: A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 µg / 5 µg; 5 µg / 5 µg) (Delivered by the Respimat® Inhaler) Compared With the Individual Components (2.5 µg and 5 µg Tiotropium, 5 µg Olodaterol) (Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [TOnado TM 1]

summary: The overall objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the RESPIMAT Inhaler) compared with the individual components ( tiotropium, olodaterol) (delivered by the RESPIMAT Inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Rabe KF, Chalmers JD, Miravitlles M, Kocks JWH, Tsiligianni I, de la Hoz A, Xue W, Singh D, Ferguson GT, Wedzicha J. Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO(®) Trials. Adv Ther. 2021 Jan;38(1):579-593. doi: 10.1007/s12325-020-01528-2. Epub 2020 Nov 11.

family: Rabe

full_name: Klaus F. Rabe

given: Klaus F.

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Kocks

full_name: Janwillem W. H. Kocks

given: Janwillem W. H.

family: Tsiligianni

full_name: Ioanna Tsiligianni

given: Ioanna

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Singh

full_name: Dave Singh

given: Dave

family: Ferguson

full_name: Gary T. Ferguson

given: Gary T.

family: Wedzicha

full_name: Jadwiga Wedzicha

given: Jadwiga

journal_name: Advances in Therapy

repository_institution: University of Dundee - Discovery Research Portal

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_institution: University of Dundee - Discovery Research Portal

title: Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO® Trials

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

ReferenceCitation: Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. No Influence on Cardiac Arrhythmia or Heart Rate from Long-Term Treatment with Tiotropium/Olodaterol versus Monocomponents by Holter ECG Analysis in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1945-1953. doi: 10.2147/COPD.S246350. eCollection 2020.

ReferenceCitation: Andreas S, McGarvey L, Bothner U, Trampisch M, de la Hoz A, Fležar M, Buhl R, Alter P. Absence of Adverse Effects of Tiotropium/Olodaterol Compared with the Monocomponents on Long-Term Heart Rate and Blood Pressure in Patients with Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1935-1944. doi: 10.2147/COPD.S246348. eCollection 2020.

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(®)/DYNAGITO(®) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

title: Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials

ReferenceCitation: Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naïve to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.

ReferenceCitation: Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(®) and OTEMTO(®) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.

title: Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO® and OTEMTO® Studies

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voß F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

ReferenceCitation: Maltais F, Buhl R, Koch A, Amatto VC, Reid J, Grönke L, Bothner U, Voß F, McGarvey L, Ferguson GT. β-Blockers in COPD: A Cohort Study From the TONADO Research Program. Chest. 2018 Jun;153(6):1315-1325. doi: 10.1016/j.chest.2018.01.008. Epub 2018 Jan 31.

title: β-Blockers in COPD

ReferenceCitation: Buhl R, Magder S, Bothner U, Tetzlaff K, Voß F, Loaiza L, Vogelmeier CF, McGarvey L. Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2017 Jan;122:58-66. doi: 10.1016/j.rmed.2016.11.011. Epub 2016 Nov 14.

ReferenceCitation: Ferguson GT, Fležar M, Korn S, Korducki L, Grönke L, Abrahams R, Buhl R. Efficacy of Tiotropium + Olodaterol in Patients with Chronic Obstructive Pulmonary Disease by Initial Disease Severity and Treatment Intensity: A Post Hoc Analysis. Adv Ther. 2015 Jun;32(6):523-36. doi: 10.1007/s12325-015-0218-0. Epub 2015 Jun 26.

ReferenceCitation: Buhl R, Maltais F, Abrahams R, Bjermer L, Derom E, Ferguson G, Fležar M, Hébert J, McGarvey L, Pizzichini E, Reid J, Veale A, Grönke L, Hamilton A, Korducki L, Tetzlaff K, Waitere-Wijker S, Watz H, Bateman E. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur Respir J. 2015 Apr;45(4):969-79. doi: 10.1183/09031936.00136014. Epub 2015 Jan 8. Erratum in: Eur Respir J. 2015 Jun;45(6):1763.

repository_institution: Lund University - Lund University Publications

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Lund University - Lund University Publications

title: Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

location_country:
Guatemala
Finland
Australia
Russian Federation
Denmark
Czech Republic
India
France
Japan
Argentina
Canada
Slovenia
Korea, Republic of
Turkey
Netherlands
Bulgaria
Hungary
China
Portugal
United States
Germany
Italy
Mexico
New Zealand
Estonia

location_facility: 1237.5.81029 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49013 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.61002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.42005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.42004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81036 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81028 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50201 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35908 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01035 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81030 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.07003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50206 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.36006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81015 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01026 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35903 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.42002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01036 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01038 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01034 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81022 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01033 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35105 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.36001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50203 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.38602 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81035 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.07002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.42003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.90004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01013 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81020 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01023 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.36002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81042 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49014 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81027 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.90005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01040 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81044 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01028 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01019 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50207 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81026 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81024 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81016 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81041 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81018 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01024 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01025 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.61001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35102 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01014 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54013 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35905 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81023 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35902 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35104 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01032 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01027 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35802 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35901 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81014 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.64002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01021 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.42001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35904 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01037 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.37001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01029 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.07001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35106 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86015 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81045 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81037 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35906 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81039 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.61004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01016 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81031 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81043 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81013 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81033 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50204 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35801 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01017 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35101 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.90001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81011 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.07005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81040 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01015 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81025 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81021 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.39001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35804 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01031 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.90002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86016 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35107 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.07004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49010 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81017 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.91007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.90003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.01039 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.54016 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.33007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.36003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45003 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81019 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.38601 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.45008 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.82006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.64001 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81032 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.35103 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.02004 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86017 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.36005 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86014 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50202 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.31009 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.50205 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.86006 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81034 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.52007 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.49012 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.37002 Boehringer Ingelheim Investigational Site

location_facility: 1237.5.81038 Boehringer Ingelheim Investigational Site


title: A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

acronym: OVERTURE

summary: To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Brazil
Sweden
Switzerland
Netherlands
United Kingdom
Germany
France
Japan
Poland
Norway
Romania
Belgium
Argentina
Australia
Spain
Turkey
United States
Czech Republic
Canada

location_facility:
Otsuka Investigational Site 2
Otsuka Investigational Site 1
Otuska Investigational Site
Otsuka Investigational Sites
Otsuka Investigational Site

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Casper C, Hascoet JM, Ertl T, Gadzinowski JS, Carnielli V, Rigo J, Lapillonne A, Couce ML, Vågerö M, Palmgren I, Timdahl K, Hernell O. Recombinant Bile Salt-Stimulated Lipase in Preterm Infant Feeding: A Randomized Phase 3 Study. PLoS One. 2016 May 31;11(5):e0156071. doi: 10.1371/journal.pone.0156071. eCollection 2016.

family: Casper

full_name: Charlotte Casper

given: Charlotte

sequence: first

family: Hascoet

full_name: Jean-Michel Hascoet

given: Jean-Michel

sequence: additional

family: Ertl

full_name: Tibor Ertl

given: Tibor

family: Gadzinowski

full_name: Janusz S. Gadzinowski

given: Janusz S.

family: Carnielli

full_name: Virgilio Carnielli

given: Virgilio

family: Rigo

full_name: Jacques Rigo

given: Jacques

family: Lapillonne

full_name: Alexandre Lapillonne

given: Alexandre

family: Couce

full_name: María L. Couce

given: María L.

family: Vågerö

full_name: Mårten Vågerö

given: Mårten

family: Palmgren

full_name: Ingrid Palmgren

given: Ingrid

family: Timdahl

full_name: Kristina Timdahl

given: Kristina

family: Hernell

full_name: Olle Hernell

given: Olle

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_normalized: HAL

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Casper C, Carnielli VP, Hascoet JM, Lapillonne A, Maggio L, Timdahl K, Olsson B, Vågerö M, Hernell O. rhBSSL improves growth and LCPUFA absorption in preterm infants fed formula or pasteurized breast milk. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):61-9. doi: 10.1097/MPG.0000000000000365.

journal_name: Journal of Pediatric Gastroenterology & Nutrition

publisher: Ovid Technologies (Wolters Kluwer Health)

title: rhBSSL Improves Growth and LCPUFA Absorption in Preterm Infants Fed Formula or Pasteurized Breast Milk

location_country:
Italy
Sweden
France
Poland
Hungary
Belgium
Russian Federation
Spain
Germany
Czech Republic

location_facility: Swedish Orphan Biovitrum Investigational Site

title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age

summary: The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.


type: EudraCT Number

title: A Phase 2b, Randomized, Double-blind Study to Evaluate the Efficacy of Tralokinumab in Adults With Uncontrolled, Severe Asthma

summary: The purpose of this study is to determine whether the addition of tralokinumab to standard asthma medication is effective in the treatment of adults with asthma.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: background

ReferenceCitation: Brightling CE, Chanez P, Leigh R, O'Byrne PM, Korn S, She D, May RD, Streicher K, Ranade K, Piper E. Efficacy and safety of tralokinumab in patients with severe uncontrolled asthma: a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Respir Med. 2015 Sep;3(9):692-701. doi: 10.1016/S2213-2600(15)00197-6. Epub 2015 Jul 28.

ReferenceCitation: Baverel PG, White N, Vicini P, Karlsson MO, Agoram B. Dose-Exposure-Response Relationship of the Investigational Anti-Interleukin-13 Monoclonal Antibody Tralokinumab in Patients With Severe, Uncontrolled Asthma. Clin Pharmacol Ther. 2018 May;103(5):826-835. doi: 10.1002/cpt.803. Epub 2017 Sep 28.

name: Clinical Pharmacology; Drug Metabolism and Pharmacokinetics, MedImmune; Cambridge UK

family: Baverel

full_name: Paul G. Baverel

given: Paul G.

family: White

full_name: Nicholas White

given: Nicholas

family: Vicini

full_name: Paolo Vicini

given: Paolo

name: Department of Pharmaceutical Biosciences; Faculty of Pharmacy, Uppsala University; Uppsala Sweden

family: Karlsson

full_name: Mats O. Karlsson

given: Mats O.

name: Clinical Pharmacology and DMPK; FortySeven Inc; Menlo Park California USA

family: Agoram

full_name: Balaji Agoram

given: Balaji

journal_name: Clinical Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: MedImmune LLC

location_country:
United States
Chile
United Kingdom
Mexico
Philippines
Germany
France
Japan
Poland
Argentina
Russian Federation
Spain
Canada
Czech Republic
Korea, Republic of

intervention_type: Other


title: A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

acronym: CAP

summary: The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

lead_sponsor: Actelion

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
United Kingdom
France
Greece
Israel
Norway
Belgium
Portugal
Turkey
Germany
Czech Republic

location_facility: CHRU de Lille, hopital Claude Huriez, Service des maladies du sang

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul

location_facility: Universitätsklinik für Innere Medizin Wien

location_facility: Hanusch Krankenhaus der Gebietskrankenkasse

location_facility: Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum

location_facility: Université Libre de Bruxelles Hopital Erasme

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 12 Weeks in Hypertensive Patients With Type 2 Diabetes Mellitus

summary: This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

ReferenceCitation: Mancia G, Cannon CP, Tikkanen I, Zeller C, Ley L, Woerle HJ, Broedl UC, Johansen OE. Impact of Empagliflozin on Blood Pressure in Patients With Type 2 Diabetes Mellitus and Hypertension by Background Antihypertensive Medication. Hypertension. 2016 Dec;68(6):1355-1364. Epub 2016 Oct 10.

ReferenceCitation: Tikkanen I, Narko K, Zeller C, Green A, Salsali A, Broedl UC, Woerle HJ; EMPA-REG BP Investigators. Empagliflozin reduces blood pressure in patients with type 2 diabetes and hypertension. Diabetes Care. 2015 Mar;38(3):420-8. doi: 10.2337/dc14-1096. Epub 2014 Sep 30.

family: Tikkanen

full_name: Ilkka Tikkanen

given: Ilkka

family: Narko

full_name: Kirsi Narko

given: Kirsi

family: Zeller

full_name: Cordula Zeller

given: Cordula

family: Green

full_name: Alexandra Green

given: Alexandra

family: Salsali

full_name: Afshin Salsali

given: Afshin

family: Broedl

full_name: Uli C. Broedl

given: Uli C.

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: Empagliflozin Reduces Blood Pressure in Patients With Type 2 Diabetes and Hypertension

ipd_sharing: Yes

ipd_sharing_description: Boehringer Ingelheim Policy on Transparency and Publication http://trials.boehringer-ingelheim.com/transparency_policy.html

lead_sponsor: Boehringer Ingelheim

location_country:
Sweden
Lebanon
Netherlands
Germany
Finland
France
Norway
Estonia
Denmark
United States
Czech Republic
Canada

location_facility: 1245.48.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37203 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10032 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35806 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37204 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31015 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10020 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10041 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10039 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31016 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37201 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10035 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31014 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.37202 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20004 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10030 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31019 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10036 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.49008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10029 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.46006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47007 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31013 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47006 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10042 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35801 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31010 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47009 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31011 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.42008 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.96002 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35805 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31017 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.31003 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.20001 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.35807 Boehringer Ingelheim Investigational Site

location_facility: 1245.48.47001 Boehringer Ingelheim Investigational Site

intervention_type: Drug


type: Other Identifier

title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin , Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease

summary: This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.

ReferenceCitation: von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhász E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.

name: Asklepios Fachkliniken GmbHGauting Germany

family: von Pawel

full_name: Joachim von Pawel

given: Joachim

name: Tennessee OncologyNashville Tennessee USA

family: Spigel

full_name: David R. Spigel

given: David R.

name: Florida Cancer SpecialistsTampa Florida USA

family: Ervin

full_name: Thomas Ervin

given: Thomas

family: Losonczy

full_name: György Losonczy

given: György

name: Aix Marseille UniversityMarseille France

name: Assistance Publique Hôpitaux de MarseilleMarseille France

name: Hôpital Nord, Oncologie Multidisciplinaire et Innovations Thérapeutiques dptMarseille France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

name: Országos Korányi TBC és Pulmonológiai IntézetBudapest Hungary

family: Juhász

full_name: Erzsébet Juhász

given: Erzsébet

name: Genentech, Inc.South San Francisco California USA

family: Anderson

full_name: Maria Anderson

given: Maria

family: McCall

full_name: Bruce McCall

given: Bruce

family: Wakshull

full_name: Eric Wakshull

given: Eric

family: Hegde

full_name: Priti Hegde

given: Priti

family: Ye

full_name: Weilan Ye

given: Weilan

family: Chen

full_name: Daniel Chen

given: Daniel

family: Chang

full_name: Ilsung Chang

given: Ilsung

family: Rhee

full_name: Ina Rhee

given: Ina

name: LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL)Grosshansdorf Germany

family: Reck

full_name: Martin Reck

given: Martin

journal_name: The Oncologist

oa_colors: green hybrid

evidence: open (via free article)

license: implied-oa

license_normalized: implied-oa

title: Randomized Phase II Trial of Parsatuzumab (Anti‐EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First‐Line Nonsquamous Non‐Small Cell Lung Cancer

lead_sponsor: Genentech, Inc.

location_country:
United States
France
Poland
Hungary
Australia
Germany
Czech Republic


title: A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared With Docetaxel in 2nd Line Subjects With Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC Stage IV)

summary: This is a phase II, open-label, multicenter, randomized study to evaluate the efficacy and safety of GSK1120212 compared with docetaxel in the second line setting for subjects with locally advanced or metastatic (Stage IV) Non-small cell lung cancer (NSCLC) harboring a KRAS mutation who have failed one platinum-containing chemotherapy regimen. A small subset of NSCLC subjects harboring BRAF, NRAS, or MEK1 mutations will be randomized in addition to the primary KRAS population, for exploratory purposes.

ReferenceCitation: Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC)†. Ann Oncol. 2015 May;26(5):894-901. doi: 10.1093/annonc/mdv072. Epub 2015 Feb 26.

family: Blumenschein

full_name: G.R. Blumenschein

suffix: Jr

family: Smit

full_name: E.F. Smit

family: Planchard

full_name: D. Planchard

given: D.

family: Kim

full_name: D.-W. Kim

family: Cadranel

full_name: J. Cadranel

given: J.

family: De Pas

full_name: T. De Pas

given: T.

family: Dunphy

full_name: F. Dunphy

given: F.

family: Udud

full_name: K. Udud

given: K.

family: Ahn

full_name: M.-J. Ahn

family: Hanna

full_name: N.H. Hanna

full_name: J.-H. Kim

family: Mazieres

full_name: J. Mazieres

full_name: S.-W. Kim

family: Baas

full_name: P. Baas

given: P.

family: Rappold

full_name: E. Rappold

given: E.

family: Redhu

full_name: S. Redhu

given: S.

family: Puski

full_name: A. Puski

given: A.

family: Wu

full_name: F.S. Wu

family: Jänne

full_name: P.A. Jänne

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

location_country:
Italy
Netherlands
France
Greece
Hungary
Spain
United States
Korea, Republic of


title: A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

summary: The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

status: Terminated

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
South Africa
Sweden
India
Finland
France
Argentina
Australia
Puerto Rico
Spain
United States

location_facility: Comprehensive Clinical Development, Inc.

location_facility: Atlanta Institute Of Medicine & Research

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)

location_facility: K & S Professional Research Services, Llc

location_facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research

location_facility: Neuropsychiatric Research Center Of Orange County

location_facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.

location_facility: Dean Foundation For Health Research & Education

location_facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

status_simplified: Unknown


title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial

acronym: Orion

summary: To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6). pii: 18m12680. doi: 10.4088/JCP.18m12680.

family: Newcomer

full_name: John W. Newcomer

given: John W.

family: Eriksson

full_name: Hans Eriksson

given: Hans

family: Zhang

full_name: Peter Zhang

given: Peter

family: Meehan

full_name: Stine R. Meehan

given: Stine R.

family: Weiss

full_name: Catherine Weiss

given: Catherine

journal_name: The Journal of Clinical Psychiatry

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ipd_sharing: No

location_country:
United States
Serbia
France
Poland
Slovakia
Romania
Hungary
Russian Federation
Germany
Canada
Ukraine


type: Registry Identifier

title: Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B Without Inhibitors

summary: This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group participants will get study medicine from the start of the study. In the other group participants will continue with their normal medicine and get study medicine after 6 months. The group will be decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will have to inject themselves with study medicine every day under the skin. This can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about three years. Participants will have to come to the clinic for up to 33 times. The time between visits will be approximately 4 weeks for the first 6 to 12months depending on the group participants are in, and approximately 8 weeks for the rest of the study. At all visits, blood samples will be taken. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Australia
Russian Federation
Denmark
Ukraine
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Thailand
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Bulgaria
Hungary
Algeria
Portugal
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Mexico
Israel
Spain
Turkey

status_simplified: Ongoing


title: An Open-Label, Multi-Center, Global Study to Evaluate Long Term Safety and Efficacy in Patients Who Are Receiving or Who Previously Received Durvalumab in Other Protocols (WAVE)

acronym: WAVE

summary: The aims of the study are to monitor the long-term safety of durvalumab, to provide continued treatment or retreatment with durvalumab to eligible patients, and to collect overall survival (OS) information.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment.

lead_sponsor: AstraZeneca

location_country:
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Switzerland
Netherlands
Vietnam
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey


status: Active, not recruiting

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Greece
Australia
Spain
Canada
United Kingdom

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Baylor Scott and White Research Institute

location_facility: Centre Hospitalier Universitaire de Nantes, HÃ´pital HÃ´tel Dieu

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis

location_facility: Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn

location_facility: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

location_facility: Allina Health Systems dba Virginia Piper Cancer Institute

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Medical Oncology Hematology Consultants Helen F Graham Cancer Center

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Centre Hospitalier Universitaire de Bordeaux - HÃ´pital Saint AndrÃ©

location_facility: University of Louisville James Graham Brown Cancer Center

location_facility: UniversitÃ¤tsklinikum Carl Gustav Carus der Technischen UniversitÃ¤t Dresden

location_facility: Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej

source: euctr

title: Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

summary: This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.


title: An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer With Prior Exposure to Hormonal Therapies

summary:
Primary Objective:

To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer

Secondary Objectives:

To compare the overall survival in the 2 treatment arms
To assess the objective response rate in the 2 treatment arms
To evaluate the disease control rate in the 2 treatment arms
To evaluate the clinical benefit rate in the 2 treatment arms
To evaluate the duration of response in the 2 treatment arms
To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
To evaluate the pharmacokinetics of amcenestrant as single agent
To evaluate health related quality of life in the 2 treatment arms
To compare the overall safety profile in the 2 treatment arms

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Greece
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Puerto Rico
China
United States
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey
Latvia

location_facility:
Investigational Site Number :4100002
Investigational Site Number :0320005
Investigational Site Number :1580004
Investigational Site Number :3800003
Investigational Site Number :0320002
Investigational Site Number :7240001
Investigational Site Number :0320001
Investigational Site Number :3920008
Investigational Site Number :3000004
Investigational Site Number :7240005
Investigational Site Number :0360002
Investigational Site Number :0320008
Investigational Site Number :3920005
Investigational Site Number :1560031
Investigational Site Number :3000001
Investigational Site Number :1240006
Investigational Site Number :1560002
Investigational Site Number :8040004
Investigational Site Number :1560016
Investigational Site Number :0360003
Investigational Site Number :1580002
Investigational Site Number :0320007
Investigational Site Number :0320006
Investigational Site Number :4100003
Investigational Site Number :8400027
Investigational Site Number :2500007
Investigational Site Number :1560024
Investigational Site Number :1560032
Investigational Site Number :8400022
Investigational Site Number :7240002
Investigational Site Number :2030003
Investigational Site Number :7240006
Investigational Site Number :1560001
Investigational Site Number :1560003
Investigational Site Number :8400034
Investigational Site Number :2030004
Investigational Site Number :8400032
Investigational Site Number :7240008
Investigational Site Number :6160003
Investigational Site Number :0760002
Investigational Site Number :0760006
Investigational Site Number :7920004
Investigational Site Number :3760001
Investigational Site Number :1240004
Investigational Site Number :8400026
Investigational Site Number :8400020
Investigational Site Number :4100001
Investigational Site Number :3920003
Investigational Site Number :3800002
Investigational Site Number :3000003
Investigational Site Number :0560001
Investigational Site Number :2500005
Investigational Site Number :1560023
Investigational Site Number :2500001
Investigational Site Number :7240004
Investigational Site Number :4840006
Investigational Site Number :7920001
Investigational Site Number :8400024
Investigational Site Number :2030002
Investigational Site Number :0560003
Investigational Site Number :8040001
Investigational Site Number :1560033
Investigational Site Number :1560010
Investigational Site Number :3760002
Investigational Site Number :1560015
Investigational Site Number :8400030
Investigational Site Number :1560025
Investigational Site Number :8400008
Investigational Site Number :6430005
Investigational Site Number :1560018
Investigational Site Number :7240003
Investigational Site Number :6430003
Investigational Site Number :6160001
Investigational Site Number :7920003
Investigational Site Number :1560014
Investigational Site Number :8400028
Investigational Site Number :4840002
Investigational Site Number :1560030
Investigational Site Number :3000002
Investigational Site Number :0760001
Investigational Site Number :3920006
Investigational Site Number :1580005
Investigational Site Number :6430002
Investigational Site Number :2500006
Investigational Site Number :1580003
Investigational Site Number :1240003
Investigational Site Number :3800001
Investigational Site Number :4280001
Investigational Site Number :8400025
Investigational Site Number :3920002
Investigational Site Number :8400016
Investigational Site Number :4100004
Investigational Site Number :4280002
Investigational Site Number :8400038
Investigational Site Number :4840005
Investigational Site Number :0760005
Investigational Site Number :0760003
Investigational Site Number :1560005
Investigational Site Number :3920009
Investigational Site Number :8040005
Investigational Site Number :8400014
Investigational Site Number :1560026
Investigational Site Number :3920004
Investigational Site Number :7920002
Investigational Site Number :1560004
Investigational Site Number :3920001
Investigational Site Number :1580001
Investigational Site Number :0360001
Investigational Site Number :0320004
Investigational Site Number :8400009
Investigational Site Number :8400018
Investigational Site Number :3760004
Investigational Site Number :3760003
Investigational Site Number :1560008
Investigational Site Number :2500008
Investigational Site Number :7240007
Investigational Site Number :8400013
Investigational Site Number :2500002
Investigational Site Number :8400015
Investigational Site Number :1560019
Investigational Site Number :1560013
Investigational Site Number :8400006
Investigational Site Number :1560027
Investigational Site Number :1560021
Investigational Site Number :0560002
Investigational Site Number :1560011


title: International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)

acronym: AboLiSh

summary: The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.

lead_sponsor: Ipsen

location_country:
Italy
Brazil
United States
Germany
France
Poland
Australia
Russian Federation
Canada

location_facility: Regional state budget health institution "City Hospital № 5"

location_facility: Wake Forest University Baptist Medical Center

location_facility: SAHI Interregional Clinical Diagnostic Center

location_facility: Università Degli studi della Campania - Luigi Vanvitelli - Neurologica

location_facility: Penn State Health Physical Medicine and Rehabilitation - Neurology

location_facility: Physical and Rehabilitation Medicine Unit at "Città della Salute e della Scienza di Torino" University Hospital - Neurology

location_facility: Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: MedStar National Rehabilitation Hospital

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: River Valley Health - Stan Cassidy Foundation - Stan Cassidy

location_facility: Dayton Center for Neurological Disorders

location_facility: Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

location_facility: Centre Hospitalier Universitaire De Reims - Hopital Maison B

location_facility: The University of Utah School of Medicine

location_facility: Istituto Scientifico di Riabilitazione di Veruno, Fondazione

location_facility: Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology

location_facility: FGBOU VO "Ural state medical university"

location_facility: Beaumont Hospital, Grosse Pointe - Neurology

location_facility: Bekhterev National Research Medical Center for Psychiatry

location_facility: Pavlov First Saint-Petersburg State Medical University - Neurology

location_facility: Medical-Rehabilitation Center of Roszdrav

location_facility: Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology

location_facility: Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology

location_facility: Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology

location_facility: Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology

location_facility: Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego

location_facility: Neurologie und Psychosomatik am Wittenbergplatz

location_facility: PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello

location_facility: Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

location_facility: Good Shepherd Rehabilitation Hospital - Neurology


title: Performance Evaluation of the VIDAS TB-IGRA Assay.

summary: This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

time_perspective: Cross-Sectional

lead_sponsor: BioMérieux

location_country:
Italy
Brazil
South Africa
India
Mexico
France
Georgia
United States
United Kingdom

location_facility: Universidade Federal de Mato Grosso do Sul (UFMS)

location_facility: Universidade Federal Da Grande Dourados (UFGD)

location_facility: TASK Applied Science, Delft Day Hospital Premises

location_facility: Autonomous University of Baja California

location_facility: University of Cape Town Centre for Lung Infection and Immunity

location_facility: National Center for Tuberculosis and Lung Disease

intervention_type: Diagnostic Test


title: An Open-label Multi-cohort Phase 1b/2 Study of Derazantinib and Atezolizumab in Patients With Urothelial Cancer Expressing Activating Molecular FGFR Aberrations

summary: The purpose of this study is to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth factor receptor (FGFR) genetic aberrations (GA) of various clinical stages of disease progression and prior treatments.

lead_sponsor: Basilea Pharmaceutica

location_country:
Italy
Austria
United States
Switzerland
Germany
France
Czechia
Poland
Hungary
Australia
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Medical Oncology - Pitié-Salpêtrière Hopital

location_facility: Englander Institute Weill Cornell Medicine

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: Greenville Health System - Prisma Health Cancer Institute

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego

location_facility: Medical Oncology Associates PS (dba Summit Cancer Centers)

location_facility: Marques de Valdecilla University Hospital

location_facility: Seoul St. Marys Hospital Catholic University of Korea

location_facility: ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio

location_facility: Midwestern Regional Medical Center, Inc. DBA CTCA, Chicago

location_facility: Seoul National University Bundang Hospital

location_facility: B.A.Z.Megyei Központi Kórház és Egyetemi Oktató Kórház

location_facility: Barts and The London School of Medicine and Dentistry - Barts Cancer Institute (BCI)

location_facility: University of Texas Southwestern Medical Center (UTSWMC)

location_facility: Hospital Universitario HM Sanchinarro CIOCC

location_facility: Ballarat Oncology & Haematology Services

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., 04-073, Warszawa, Poland

location_facility: Cross Cancer Institute Alberta Health Services

location_facility: IRCCS - Istituto Europeo di Oncologia IEO


title: A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-99712, a BCMA Antibody-Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: Study CC-99712-MM-001 is an open-label, Phase 1, dose escalation (Part A) and expansion (Part B), First-in-Human (FIH) clinical study of CC-99712 in monotherapy or combination in participants with relapsed and refractory multiple myeloma (MM). The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-99712, administered intravenously (IV) in monotherapy (Arm 1) or combination (Arm 2), to determine the maximum tolerated dose (MTD) of CC-99712 guided by a Bayesian logistic regression model (BLRM). A modified accelerated titration design will also be used for Arm 1 and Arm 2. The MTD may be established separately for CC-99712 administered at Q3W and/ or Q4W schedules. The expansion part (Part B) will further evaluate the safety and efficacy of CC-99712 in monotherapy (Arm 1) or combination (Arm 2) administered at or below the MTD in selected expansion cohorts in order to determine the RP2D. One or more doses or dosing regimens may be selected for cohort expansion. All participants will be treated until confirmed disease progression per IMWG criteria, unacceptable toxicity, or participants//Investigator decision to withdraw.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
Italy
France
Spain
United States
Canada

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: University of California San Diego Moores Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Istituto Nazionale dei Tumori | Fondazione IRCCS

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Ospedale Vittorio Emanuele


title: An Open-Label, Randomized, Multicenter Phase 2 Trial of Dasatinib (SPRYCEL®) vs. Dasatinib Plus Smoothened Antagonist (BMS-833923) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML).

summary: The purpose of the study is to compare response rates in newly diagnosed Chronic Phase (CP) CML subjects treated with dasatinib plus BMS-833923 versus dasatinib alone.

location_country:
United States
Finland
France
Poland
Belgium
Argentina
Spain
Canada

location_facility:
Tennessee Oncology Pllc
Huntsman Cancer Institute
Local Institution
John Theurer Cancer Center


title: A 12-week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared With Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

ReferenceCitation: Agustí A, de Teresa L, De Backer W, Zvarich MT, Locantore N, Barnes N, Bourbeau J, Crim C. A comparison of the efficacy and safety of once-daily fluticasone furoate/vilanterol with twice-daily fluticasone propionate/salmeterol in moderate to very severe COPD. Eur Respir J. 2014 Mar;43(3):763-72. doi: 10.1183/09031936.00054213. Epub 2013 Oct 10.

family: Agusti

full_name: A. Agusti

family: de Teresa

full_name: L. de Teresa

given: L.

family: De Backer

full_name: W. De Backer

given: W.

family: Zvarich

full_name: M. T. Zvarich

given: M. T.

family: Locantore

full_name: N. Locantore

given: N.

family: Barnes

full_name: N. Barnes

family: Bourbeau

full_name: J. Bourbeau

family: Crim

full_name: C. Crim

given: C.

journal_name: European Respiratory Journal

publisher: European Respiratory Society (ERS)

publisher_dissemination: European Respiratory Society

publisher_group: European Respiratory Society

publisher_normalized: European Respiratory Society

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Philippines
France
Poland
Belgium
Russian Federation
Spain
Germany
Ukraine


title: A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

summary: This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Malaysia
Belgium
Australia
Taiwan
France
Japan
Thailand
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Ireland
China
Germany
United States
United Kingdom
Italy
Brazil
Israel
New Zealand
Spain
Turkey

location_facility: St Vincents University Hospital ( Site 0521)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0271)

location_facility: UZA University Hospital Antwerp ( Site 0202)

location_facility: Universitaetsklinikum Koeln ( Site 0274)

location_facility: Inonu Universitesi Medical Fakultesi ( Site 0501)

location_facility: The First Hospital of Jilin University ( Site 0131)

location_facility: Baskent University Adana Training Hospital ( Site 0499)

location_facility: Guangdong Provincial People s Hospital ( Site 0161)

location_facility: National Cheng Kung University Hospital ( Site 0864)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0863)

location_facility: Winthrop University Hospital ( Site 0059)

location_facility: Severance Hospital Yonsei University Health System ( Site 0836)

location_facility: Universitaetsklinikum Aachen AOER ( Site 0275)

location_facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 0329)

location_facility: West China Hospital of Sichuan University ( Site 0147)

location_facility: A.P.H. Paris, Hopital Beaujon ( Site 0247)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0535)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0433)

location_facility: Hacettepe University Faculty of Medicine ( Site 0498)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0332)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 0309)

location_facility: Maharaj Nakorn Chiang Mai Hospital ( Site 0887)

location_facility: Staedtisches Klinikum Dresden ( Site 0272)

location_facility: Peking Union Medical College Hospital ( Site 0150)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0182)

location_facility: Policlinico Universitario Campus Biomedico ( Site 0328)

location_facility: Medizinische Hochschule Hannover ( Site 0265)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0495)

location_facility: Hospital Universitario General de Asturias ( Site 0434)

location_facility: National Cancer Center Hospital East ( Site 0081)

location_facility: Osaka International Cancer Institute ( Site 0084)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0145)

location_facility: Charite - Universtitatsmedizin Berlin CCM ( Site 0269)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0494)

location_facility: Centro Oncologico Riojano Integral ( Site 0584)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0767)

location_facility: Taipei Veterans General Hospital ( Site 0861)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0620)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0834)

location_facility: University of Alabama at Birmingham Comprehensive Cancer Ctr ( Site 0016)

location_facility: CHU Bordeaux Haut-Leveque Centre Francois Magendie ( Site 0245)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0610)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0014)

location_facility: Saint Francis Health System ( Site 0051)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0609)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0082)

location_facility: A.O. di Rilievo Nazionale e di alta Specializzazione Garibaldi ( Site 0330)

location_facility: Tallaght University Hospital ( Site 0522)

location_facility: Oncobio Servicos de Saude SA ( Site 0604)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0136)

location_facility: Winship Cancer Institute of Emory University ( Site 0013)

location_facility: Azienda Ospedaliera Universitaria di Verona ( Site 0334)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0155)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0601)

location_facility: CHU Clermont-Ferrand - Site Estaing ( Site 0249)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0525)

location_facility: Korea University Guro Hospital ( Site 0832)

location_facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 0502)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0078)

location_facility: Royal Free London NHS Foundation Trust ( Site 0520)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0432)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0038)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0839)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0157)

location_facility: Chungnam National University Hospital ( Site 0840)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0180)

location_facility: Kobe City Medical Center General Hospital ( Site 0087)

location_facility: Zhongshan Hospital Fudan University ( Site 0129)

location_facility: University of California San Diego Moores Cancer Center ( Site 0008)

location_facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0606)

location_facility: Columbia University/Herbert Irving Cancer Center ( Site 0009)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0622)

location_facility: Gallipoli Medical Research Foundation ( Site 0705)

location_facility: Pantai Hospital Kuala Lumpur ( Site 0771)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0045)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 0496)

location_facility: Hospital de Caridade de Ijui ( Site 0602)

location_facility: Maastricht University Medical Centre ( Site 0347)

location_facility: University Malaya Medical Centre ( Site 0770)

location_facility: Klinikum der Ludwig - Maximilian Universitat Munchen ( Site 0264)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0326)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0506)

location_facility: Erciyes Universitesi Tip Fakultesi ( Site 0500)

location_facility: Ajou University Hospital, Clinical Research Center ( Site 0838)

location_facility: University of California - San Francisco ( Site 0030)

location_facility: Fudan University Shanghai Cancer Center ( Site 0160)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0623)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0865)

location_facility: Harbin Medical University Cancer Hospital ( Site 0133)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0435)

location_facility: King Chulalongkorn Memorial Hospital ( Site 0884)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0333)

location_facility: Princess Margaret Hospital. ( Site 0856)

location_facility: Hunan Provincial People Hospital ( Site 0142)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0158)

location_facility: Seoul National University Bundang Hospital ( Site 0833)

location_facility: The Christie NHS Foundation Trust ( Site 0537)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0580)

location_facility: McGill University Health Centre ( Site 0179)

location_facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 0055)

location_facility: University of Colorado Hospital ( Site 0011)

location_facility: Universitair Medisch Centrum Utrecht ( Site 0351)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0607)

location_facility: Universitaetsklinikum Essen ( Site 0273)

location_facility: Associacao Hospitalar Moinhos de Vento ( Site 0599)

location_facility: Western Health-Sunshine Hospital ( Site 0709)

location_facility: China Medical University Hospital ( Site 0862)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0853)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0268)

location_facility: Fujian Provincial Cancer Hospital ( Site 0154)

location_facility: First Affiliated Hospital of The Third Military Medical University ( Site 0130)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0857)

location_facility: Aichi Cancer Center Hospital ( Site 0080)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0518)

location_facility: Mid North Coast Cancer Institute ( Site 0708)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0248)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0603)

location_facility: CHA Bundang Medical Center CHA University ( Site 0835)

location_facility: Chonnam National University Hwasun Hospital ( Site 0837)

location_facility: Hospital Regional Universitario Carlos Haya ( Site 0431)

location_facility: OHSU Center for Health & Healing ( Site 0044)

location_facility: National Taiwan University Hospital ( Site 0860)

location_facility: Erasmus University Medical Center ( Site 0352)


lead_sponsor: PDC*line Pharma SAS

location_country: Germany Belgium France

location_facility: Centre Léon Bérard, Centre de lutte contre le cancer

location_facility: Assistance Publique Hôpitaux de Marseille, Centre d'essais précoces en cancérologie de Marseille (CEPCM)

location_facility: Institut régional du Cancer de Montpellier

title: An Open-label, Dose-escalation, Phase I/II Study to Assess the Safety, the Tolerability, the Immunogenicity and the Preliminary Clinical Activity of the Therapeutic Cancer Vaccine, PDC*lung01, Associated or Not With Anti-PD-1 Treatment in Patients With Non-small-cell Lung Cancer (NSCLC)

summary: PDC-LUNG-101 trial is an open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer.


title: A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion

summary:
The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.

The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Italy
United States
France
Japan
Israel
Spain
Germany

location_facility:
Research site
Research Facility
Research Site


lead_sponsor: Arena Pharmaceuticals

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Ukraine
India
Spain
Croatia
France
Japan
Lithuania
Poland
Slovakia
Thailand
Argentina
Moldova, Republic of
Canada
Korea, Republic of
Turkey
South Africa
Chile
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Lebanon
Mexico
Czechia
Israel
Georgia
Belarus
Estonia
Latvia

acronym: ELEVATE UC OLE

location_facility: Great Lakes Medical Research, LLC - Beachwood

location_facility: Department of Propaedeutics of Internal Medicine Ivano-Frankivsk National Medical University

location_facility: Topolowa Medicenter Mrozek & Wspolnicy Spolka Jawna

location_facility: Dept of Gastroenterology, Szent Gyorgy Hospital

location_facility: Health Care Institution "10th City Clinical Hospital"

location_facility: General Hospital "Dr.Tomislav Bardek" Koprivnica

location_facility: Medical College of Wisconsin Clinical Trials Office

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Timofei Mosneaga Republican Clinical Hospital, Department of Gastroenterology

location_facility: Gastroenterology Associates of Tidewater

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Great Lakes Medical Research, LLC - Mentor

location_facility: Vilnius University Hospital Santaros Clinics, Center of Hepatology, Gastroenterology and Dietology

location_facility: Republican Panevezys Hospital, Department of Gastroenterology

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: Clinical Hospital of the Ministry of Health, Labor and Social Protection

location_facility: Communal Non-Commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council

location_facility: Children's Center for Digestive Health Care, LLC

location_facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: UCI Institute for Clinical Translational Services

location_facility: SBIH of Nizhniy Novgorod region "Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko"

location_facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU

location_facility: Private Educational Institution of Higher Education "Medical University "REAVIZ"

location_facility: State Budgetary Healthcare Institution "Penza Region Clinical Hospital n.a. N.N. Burdenko"

location_facility: Biopharma Informatic, Inc. Research Center

location_facility: Iwate Medical University Uchimaru Medical Center

location_facility: LTD Israeli-Georgian Medical Research clinic Helsicore

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: EMC INSTYTUT MEDYCZNY SA, EuroMediCare Szpital Specjalistyczny z Przychodnia

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: SAIH "Kemerovo Regional Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika -Gasztroenterologia

location_facility: Kremenchuk first city hospital n.a. O.T. Bohaievskyi

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Allmedica Badania Kliniczne Sp. z o.o. Sp.k.

location_facility: Stavropol Regional Clinical Diagnostic Centre

location_facility: Washington University School of Medicine

location_facility: Barts Health NHS Trust - Whipps Cross University Hospital

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Government Medical College and Super Speciality Hospital

location_facility: Gastromed Kralisz, Romatowski, Stachurska sp.j

location_facility: P. Stradins Clinical University Hospital

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: American University of Beirut Medical Center

location_facility: Clinic of Plastic and Laser Surgery "Anturium" LLC

location_facility: DiGiovanna Institute for Medical Education & Research

location_facility: National Military Medical Clinical Center Main Military Clinical Hospital

location_facility: Dr. Peter Bossuyt - GI Clinical Research Center

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: Aalborg University Hospital, department of medical gastroenterology

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Karkonoskie Centrum Badan Klinicznych - Lexmedica

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

location_facility: Great Lakes Medical Research, LLC - Warren

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Endoscopy Center of the North Shore - Gen1 Research

location_facility: LTD Central University Clinic After Academic N. Kipshidze

location_facility: JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

location_facility: Municipal non-profit enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council", Ga

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - CEMAD

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen

location_facility: UAB "Inlita", Santaros Clinical Trials Centre

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Medical Clinical Investigational Center Medical Center LLC Health Clinic

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada s.c.

location_facility: Duke University Medical Center GI Clinical Research Unit

location_facility: Federal State Budgetary Educational Institution of higher Education "First Saint Petersburg State Medical University"

location_facility: San Diego Gastroenterology Medical Associates

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Communal Noncommercial Enterprise Ye.Ye. Karabelesh Kherson City Clinical Hospital of Kherson City

location_facility: UF Health Jacksonville Gastroenterology-Emerson

location_facility: University Hospital Antwerp Gastroenterology and Hepatology Department

location_facility: LLC "Gastroenterological centre Expert",

location_facility: Kocaeli University Research and Training Hospital

location_facility: University of California San Diego Medical Center

location_facility: Marshall University Department of Clinical Research

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Digestive Health Specialists of the Southeast

location_facility: Odesa regional clinical hospital, regional center of gastroenterology, surgical department

location_facility: Federal state Budgetary Educational Institution of Higher Education "North-Western Medical University"

location_facility: SPb SBIH "City Hospital # 40 of Kurortnyi region"

location_facility: Guy's and St Thomas NHS Foundation Trust

location_facility: SUBARU Health Insurance Society Ota Memorial Hospital

location_facility: Postgraduate department of Medicine, GSVM Medical college

location_facility: Hospital General Universitario de Alicante

location_facility: UMHAT "Sv. Ivan Rilski", EAD,Clinic of gastroenterology

location_facility: Communal Non-Commercial Enterprise Lviv Clinical Hospital of Emergency Medical Care

location_facility: Diagnostic-Consultative Center I - Sliven, EOOD

location_facility: Great Lakes Medical Research, LLC - Harrisburg

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Institution "Gomel Regional Clinical Hospital"

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: Lake Success Gastroenterology, a Division of Pro Healthcare

location_facility: Naugatuck Valley Gastroenterology Consultants

location_facility: Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Diagnostic Consultation Center CONVEX EOOD

title: An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 [NCT03945188] or APD334-302 [NCT03996369] or APD334-210 [NCT04607837]).