title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

acronym: OCTAVE

summary: This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Nov 7. pii: izac084. doi: 10.1093/ibd/izac084. [Epub ahead of print]

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2022 Nov 7. doi: 10.1007/s40271-022-00603-w. [Epub ahead of print]

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panés J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2022 Jun 1. pii: izac063. doi: 10.1093/ibd/izac063. [Epub ahead of print]

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Apr 5. pii: izac061. doi: 10.1093/ibd/izac061. [Epub ahead of print]

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Dubinsky MC, DiBonaventura M, Fan H, Bushmakin AG, Cappelleri JC, Maller E, Thorpe AJ, Salese L, Panés J. Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):983-993. doi: 10.1093/ibd/izaa193.

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Hanauer S, Panaccione R, Danese S, Cheifetz A, Reinisch W, Higgins PDR, Woodworth DA, Zhang H, Friedman GS, Lawendy N, Quirk D, Nduaka CI, Su C. Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):139-147. doi: 10.1016/j.cgh.2018.07.009. Epub 2018 Sep 10.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum in: Intest Res. 2018 Jul;16(3):499-501.

ReferenceCitation: Panés J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum in: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panés J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

lead_sponsor: Pfizer

location_country:
Croatia
Serbia
Spain
United Kingdom
Ukraine
United States
Romania
Belgium
South Africa
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Latvia
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Colombia
Netherlands

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.

location_facility: Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: H-T Centrum Medyczne sp. z o.o. sp. komandytowa

location_facility: Austin Gastroenterology PA/Professional Quality Research, Inc.

location_facility: Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék

location_facility: State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly

location_facility: Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat

location_facility: Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: The University of Texas Health Science Center at Houston

location_facility: Hanyang University Guri Hospital, Clinical Laboratory

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: Minicipal Institution "City Hospital #7" Therapeutic Department,

location_facility: Citrus Surgery & Endoscopy Center (Colonoscopy)

location_facility: Universitäetsklinik Schleswig-Holstein, Campus Kiel

location_facility: VCU Health System Digestive Health Center

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: University Hospital Center Osijek, Clinic of Internal Medicine,

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: University Hospital Center Zagreb,Department of Gastroenterology

location_facility: Vanderbilt University Medical Center - GCRC

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Municipal institution of healthcare "City clinical hospital 12"

location_facility: Municipal institution of healthcare "Clinical Hospital # 2"

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion

location_facility: The Gastroenterology Group of South Jersey

location_facility: Vanderbilt University Medical Center - GI Research Office

location_facility: Vanderbilt University Medical Center - Drug Shipment

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Department of Gastroenterology, Old Building

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Vanderbilt University Medical Center - IBD Clinic

location_facility: University Medical Center Groningen (UMCG)

location_facility: Chevy Chase Endoscopy Center (Endoscopies Only)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: State Institution Institute of Gastroenterology of the National Academy of Medical Sciences

location_facility: The Edith Wolfson Medical Center/Gastroenterology Institute

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

location_facility: Carolina Research - Carolina Digestive Diseases

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii,

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital

location_facility: Vanderbilt University Medical Center - Heart Station

location_facility: Connecticut Clinical Research Foundation

location_facility: Vanderbilt University Medical Center - Radiology

location_facility: Virginia Commonwealth University, Clinical Research Services (CRSU)

location_facility: Concord Hospital -Concord Repatriation Hospital

location_facility: East Tallinn Central Hospital Internal Medicine Clinic

location_facility: CHA Bundang Medical Center, CHA University

location_facility: VCU Medical Center Investigational Drug Service (IDS)

location_facility: Medical Clinical Research Center "Health Clinic" on the base of


type: EudraCT Number

type: Registry Identifier

title: A Phase-3 Randomized, Double-Blind, Efficacy and Safety Study Evaluating the Fixed Dose Combinations of TAK-491 Plus Chlorthalidone (40/12.5 mg and 40/25 mg) in Subjects With Grades 2 or 3 Essential Hypertension, Who Do Not Achieve Target Blood Pressure Following Treatment With TAK-491 40 mg Monotherapy

summary: The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Takeda

location_country:
Poland
Serbia
Spain
Italy
United Kingdom
Estonia
Netherlands
Lithuania
Sweden
Hungary
France
Germany
Bulgaria
Slovakia

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of Inhaled Fluticasone Furoate in the Treatment of Persistent Asthma in Adults and Adolescents Currently Receiving Mid to High Strength Inhaled Corticosteroids.

summary: A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of two doses of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids.

ReferenceType: derived

ReferenceCitation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157.

ReferenceCitation: Woodcock A, Lötvall J, Busse WW, Bateman ED, Stone S, Ellsworth A, Jacques L. Efficacy and safety of fluticasone furoate 100 μg and 200 μg once daily in the treatment of moderate-severe asthma in adults and adolescents: a 24-week randomised study. BMC Pulm Med. 2014 Jul 9;14:113. doi: 10.1186/1471-2466-14-113.

ReferenceCitation: Svedsater H, Jacques L, Goldfrad C, Bleecker ER. Ease of use of the ELLIPTA dry powder inhaler: data from three randomised controlled trials in patients with asthma. NPJ Prim Care Respir Med. 2014 Jun 26;24:14019. doi: 10.1038/npjpcrm.2014.19.

ReferenceCitation: Svedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.

ipd_sharing: Yes

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:
Russian Federation
Argentina
United States
Chile
France
Mexico


status: Active, not recruiting

acronym: OPERA II

title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

study_completion_date_type: Anticipated

lead_sponsor: Hoffmann-La Roche

source: euctr

study_start_date_type: Actual

ReferenceCitation: Arnold DL, Sprenger T, Bar-Or A, Wolinsky JS, Kappos L, Kolind S, Bonati U, Magon S, van Beek J, Koendgen H, Bortolami O, Bernasconi C, Gaetano L, Traboulsee A. Ocrelizumab reduces thalamic volume loss in patients with RMS and PPMS. Mult Scler. 2022 Oct;28(12):1927-1936. doi: 10.1177/13524585221097561. Epub 2022 Jun 7.

ReferenceCitation: Krishnan AP, Song Z, Clayton D, Gaetano L, Jia X, de Crespigny A, Bengtsson T, Carano RAD. Joint MRI T1 Unenhancing and Contrast-enhancing Multiple Sclerosis Lesion Segmentation with Deep Learning in OPERA Trials. Radiology. 2022 Mar;302(3):662-673. doi: 10.1148/radiol.211528. Epub 2021 Dec 14.

ReferenceCitation: Giovannoni G, Kappos L, de Seze J, Hauser SL, Overell J, Koendgen H, Manfrini M, Wang Q, Wolinsky JS. Risk of requiring a walking aid after 6.5 years of ocrelizumab treatment in patients with relapsing multiple sclerosis: Data from the OPERA I and OPERA II trials. Eur J Neurol. 2022 Apr;29(4):1238-1242. doi: 10.1111/ene.14823. Epub 2021 May 5.

ReferenceCitation: Hauser SL, Kappos L, Arnold DL, Bar-Or A, Brochet B, Naismith RT, Traboulsee A, Wolinsky JS, Belachew S, Koendgen H, Levesque V, Manfrini M, Model F, Hubeaux S, Mehta L, Montalban X. Five years of ocrelizumab in relapsing multiple sclerosis: OPERA studies open-label extension. Neurology. 2020 Sep 29;95(13):e1854-e1867. doi: 10.1212/WNL.0000000000010376. Epub 2020 Jul 20.

ReferenceCitation: Kappos L, Wolinsky JS, Giovannoni G, Arnold DL, Wang Q, Bernasconi C, Model F, Koendgen H, Manfrini M, Belachew S, Hauser SL. Contribution of Relapse-Independent Progression vs Relapse-Associated Worsening to Overall Confirmed Disability Accumulation in Typical Relapsing Multiple Sclerosis in a Pooled Analysis of 2 Randomized Clinical Trials. JAMA Neurol. 2020 Sep 1;77(9):1132-1140. doi: 10.1001/jamaneurol.2020.1568.

ReferenceCitation: Hauser SL, Bar-Or A, Comi G, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Montalban X, Rammohan KW, Selmaj K, Traboulsee A, Wolinsky JS, Arnold DL, Klingelschmitt G, Masterman D, Fontoura P, Belachew S, Chin P, Mairon N, Garren H, Kappos L; OPERA I and OPERA II Clinical Investigators. Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):221-234. doi: 10.1056/NEJMoa1601277. Epub 2016 Dec 21.

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Russian Federation
Argentina
Turkey
Mexico
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Germany
Bulgaria
Belarus
Ireland
France

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: MHAT National Cardiology Hospital, EAD; Neurology

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Samodz.Publi.Szpital Kliniczny; nr 4 w Lublinie

location_facility: Institut Catala d´Oncologia Hospital Germans Trias i Pujol

location_facility: Hospital CIMA Chihuahua; Centro de Investigación Clínicatorre de Consultoriospiso 4

location_facility: Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr

location_facility: Wayne State University; Department of Neurology

location_facility: Krajska zdravotni, a. s. - Nemocnice Teplice, o. z.; Neurologicke oddeleni

location_facility: Hôpital Maisonneuve - Rosemont; Recherche Clinique de Neurologie

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Mun.Med.Proph.Inst."Chernihiv Reg.Hosp."; Neurology Department

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Fifth MHAT-Sofia AD; Neuro Dept with Vascular Unit

location_facility: Kings College Hospital; Neurosciences Clinical Trials Office

location_facility: Saratov State Medical University of RosZdrav; Neurology

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; Farmacia Interna

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie; Oddzial Neurologiczny z Pododdzialem Udarowym

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Road Clinical Hospital of Donetsk Station; Neurology Department

location_facility: Pardubicka Krajska Nemocnice; Department of Neurology

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: Associated Neurologists of Southern CT PC

location_facility: MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: State institution of health care - Territorial Clinical Hospital

location_facility: Hôpital General - Service de neurologie; Service de neurologie

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Miami; Dept. of Neurology MS Center

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Neurologische Gemeinschaftspraxis Dr. Lang, Prof. Schreiber, Dr. Krauß, Dr. Kornhuber

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: State Institution V.K. Gusak Institute of Urgent and Recover; Dep of Reconstructive Angioneurology a

location_facility: Sankt Gertrauden Krankenhaus; Neurologisches Facharztzentrum

location_facility: Territory Neurology and Research Institute

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Collaborative Neuroscience Research, LLC

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: University of Alberta; Northern Alberta Trials & Research Centre

location_facility: Hospital Mexico Americano SC; Departamento de Electroencefalografía

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Hospital Regional Universitario de Malaga

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: ALPI-Inst. de Rehabilitacion Marcelo Fitte

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Hospital Angeles Culiacan; Neurociencias

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii

location_facility: City General Hospital; Department of Neurology

location_facility: Kirov City Clinical Hospital #1; Neurology Department

location_facility: Vseobecna nemocnica s poliklinikou Levoca a.s.

location_facility: SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department

location_facility: Karolinska Universitetssjukhuset Solna; Neurology

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: University of Texas Southwestern Medical Center

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: MHATNP Sv.Naum EAD; Clinic for intensive treatment of neurology diseases

summary: This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks).

status_simplified: Ongoing


title: A Phase 3, Multicenter, Open-label, Extension Study to Assess the Safety and Tolerability of Epratuzumab Treatment in Systemic Lupus Erythematosus Subjects

summary: The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

lead_sponsor: UCB Pharma

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
South Africa
Belgium
Czechia
Poland
Hong Kong
Russian Federation
Australia
Israel
Mexico
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Estonia
Korea, Republic of
France


title: Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial.

summary: the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arastéh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

lead_sponsor: Boehringer Ingelheim

location_country:
Brazil
Spain
Italy
United Kingdom
Switzerland
United States
France
Germany

location_facility: 1220.19.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3903 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0044 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3904 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0045 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5503 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4919 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0060 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4920 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4922 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3906 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0026 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0031 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5505 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3902 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4921 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0084 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4923 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0016 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5508 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3307 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0021 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0086 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5502 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4924 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3306 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0014 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3907 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5501 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3905 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0079 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.5506 Boehringer Ingelheim Investigational Site

location_facility: 1220.19.0008 Boehringer Ingelheim Investigational Site


title: A 12 Week Study to Evaluate the Effect of Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) on Arterial Stiffness Compared With Tiotropium Bromide 18 mcg Delivered Once Daily Via a HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

summary: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) > 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.

ReferenceCitation: Pepin JL, Cockcroft JR, Midwinter D, Sharma S, Rubin DB, Andreas S. Long-acting bronchodilators and arterial stiffness in patients with COPD: a comparison of fluticasone furoate/vilanterol with tiotropium. Chest. 2014 Dec;146(6):1521-1530. doi: 10.1378/chest.13-2859.

location_country:
Italy
Russian Federation
Argentina
Ukraine
France
Norway
Germany


title: A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease

summary: This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.

ReferenceCitation: Lacroix A, Bronstein MD, Schopohl J, Delibasi T, Salvatori R, Li Y, Barkan A, Suzaki N, Tauchmanova L, Ortmann CE, Ravichandran S, Petersenn S, Pivonello R. Long-acting pasireotide improves clinical signs and quality of life in Cushing's disease: results from a phase III study. J Endocrinol Invest. 2020 Nov;43(11):1613-1622. doi: 10.1007/s40618-020-01246-0. Epub 2020 May 8.

ReferenceCitation: Newell-Price J, Pivonello R, Tabarin A, Fleseriu M, Witek P, Gadelha MR, Petersenn S, Tauchmanova L, Ravichandran S, Gupta P, Lacroix A, Biller BMK. Use of late-night salivary cortisol to monitor response to medical treatment in Cushing's disease. Eur J Endocrinol. 2020 Feb;182(2):207-217. doi: 10.1530/EJE-19-0695.

ReferenceCitation: Fleseriu M, Petersenn S, Biller BMK, Kadioglu P, De Block C, T'Sjoen G, Vantyghem MC, Tauchmanova L, Wojna J, Roughton M, Lacroix A, Newell-Price J. Long-term efficacy and safety of once-monthly pasireotide in Cushing's disease: A Phase III extension study. Clin Endocrinol (Oxf). 2019 Dec;91(6):776-785. doi: 10.1111/cen.14081. Epub 2019 Oct 1.

ReferenceCitation: Lacroix A, Gu F, Gallardo W, Pivonello R, Yu Y, Witek P, Boscaro M, Salvatori R, Yamada M, Tauchmanova L, Roughton M, Ravichandran S, Petersenn S, Biller BMK, Newell-Price J; Pasireotide G2304 Study Group. Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Lancet Diabetes Endocrinol. 2018 Jan;6(1):17-26. doi: 10.1016/S2213-8587(17)30326-1. Epub 2017 Oct 12. Erratum in: Lancet Diabetes Endocrinol. 2018 Jan;6(1):e1.

ReferenceCitation: Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Pituitary. 2016 Oct;19(5):536-43. doi: 10.1007/s11102-016-0734-1. Review.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Argentina
Canada
Thailand
United States
France
China
India
Belgium
Israel
Germany
Peru
Turkey
Japan

location_facility: University of California at Los Angeles UCLA Tiverton

location_facility: Oregon Health & Sciences University DeptofOregonHealth&Sciences(2)

location_facility: Vanderbilt University Medical Center CSOM230G2304

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Emory University School of Medicine/Winship Cancer Institute G2304 - C2301

location_facility: University of Pennsylvania - Clinical Studies Unit Unniv SC

location_facility: Mount Sinai School of Medicine Mt. Sinai Medical Center

location_facility: Pituitary Center, Division of Endocrinology SC


type: Other Identifier

title: A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) Infection

summary: The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

design_allocation: Non-Randomized

primary_purpose: Other

ReferenceCitation: Zoulim F, Moreno C, Lee SS, Buggisch P, Horban A, Lawitz E, Corbett C, Lenz O, Fevery B, Verbinnen T, Shukla U, Jessner W. A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection. Virol J. 2018 Jan 30;15(1):26. doi: 10.1186/s12985-018-0936-4.

lead_sponsor: Janssen R&D Ireland

location_country:
Poland
Russian Federation
Canada
United States
France
Belgium
Germany


title: Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Gadobutrol-enhanced Magnetic Resonance Angiography (MRA) After a Single Injection of 0.1 mmol/kg of Gadobutrol in Subjects With Known or Suspected Renal Artery Disease

acronym: GRAMS

summary:
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.

This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.

MRA and CTA images will be collected for an independent review (blinded read).

primary_purpose: Diagnostic

lead_sponsor: Bayer

location_country:
Poland
Taiwan
Brazil
Austria
Argentina
Czech Republic
Switzerland
Korea, Republic of
United States
France
Turkey
Colombia
Germany


title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6). pii: 2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

ReferenceCitation: Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS® trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

ReferenceCitation: Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(®) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

ReferenceCitation: Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS® trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

ReferenceCitation: Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5). pii: 1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

ReferenceCitation: Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

ReferenceCitation: Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

ReferenceCitation: Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

ReferenceCitation: Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

ReferenceCitation: Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum in: N Engl J Med. 2015 Aug 20;373(8):782.

ReferenceCitation: Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

location_country:
Portugal
Spain
Greece
Russian Federation
Mexico
Netherlands
Finland
Canada
Korea, Republic of
United States
Chile
China
France
India
Japan
Germany
Turkey

location_facility: 1199.34.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35101 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10093 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35107 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81060 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10070 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10069 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10100 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81059 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35801 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81062 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10077 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10060 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86057 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.52001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10084 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10086 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81061 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.07003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.07001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10064 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10082 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10066 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34009 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35102 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10074 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86052 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.02003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10089 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.56001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10101 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91056 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81058 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33007 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81057 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10083 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30005 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91051 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34008 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10088 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81052 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10090 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10080 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10079 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.31001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10085 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.31003 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.91054 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81053 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10092 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.35103 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10073 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86055 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.30001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10078 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.90001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10067 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10075 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.86058 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.49011 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.81063 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.82002 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10087 Boehringer Ingelheim Investigational Site

location_facility: 1199.34.10095 Boehringer Ingelheim Investigational Site


title: An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

acronym: SPARTAN

summary: The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Italy
United Kingdom
United States
France
Germany

location_facility:
Metropolis Medical Pc
Aids Care
Consultive Medicine
Eisenhower Medical Center
Triple O Medical Services, P.A.
The Research Institute
Health For Life Clinic Pllc
Local Institution
Orange County Health Dept.


title: A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer

location_country:
Poland
Spain
Italy
United Kingdom
Australia
United States
France
Belgium
Germany

summary: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

summary: The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

ReferenceCitation: Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.

lead_sponsor: Gilead Sciences

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

location_facility: CHICAS - Centre Hospitalier Intercommunal des Alpes du sud, site de GAP

location_facility: Universitätsklinikum Jena Clinic for Internal Medicine II

location_facility: UO Broncopneumologia IRCCS Fondazione Cà Granda Milano

location_facility: GBS RE Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Royal Devon and Exeter Hospital, NHS Foundation Trust

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Tampa General Hospital - New Lung Associates

location_facility: Ospendale Civile Maggiore Centro Regionale Fibrosi Cistica

location_facility: University of Texas Health Science Center at Tyler

location_facility: University of Wisconsin Hospital and Clinics

location_facility: The Oregon Clinic P.C./ Pulmonary Division

location_facility: Sir William Leech Centre for Lung Research, Freeman Hospital

location_facility: Pulmonary & Critical Care Associates of Baltimore

location_facility: Research Center for Medical Studies (RCMS)

location_facility: Columbia University, NY Presbyterian Hospital

location_facility: Service Activite Ambulatoire Pole Cardiovasculaire Hopital Nord

location_facility: University of Miami Miller School of Medicine

location_facility: University of Pennsylvania Medical Center

location_facility: Sarasota Memorial Hospital - Clinical Research Center

location_facility: Medical College of Wisconsin Froedtert Hospital

location_facility: Pulmonary Consultants & Primary Care Physicians Medical Group, Inc.

location_facility: The Lung Centre at Vancouver General Hospital

location_facility: Kelowna Respiratory Research and Allergy Clinic


title: A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

acronym: D-LITE

summary: The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

location_country:
Spain
Italy
Australia
New Zealand
Puerto Rico
United States
France
Japan
Germany

location_facility: University Of Colorado Denver And Hospital

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Bristol-Myers Squibb/David E. Bernstein, Md

intervention_type: Biological


title: Clinical Efficacy, Immunogenicity, Clinical Tolerability and Assessment of Safety of gpASIT+TM Administered Orally, According to Two Administration Schedules, for the Prophylaxis of Seasonal Grass Pollen Rhinoconjunctivitis

summary: The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.

primary_purpose: Prevention

lead_sponsor: BioTech Tools S.A.

location_country: France Luxembourg Belgium

location_facility:
UZ Antwerpen
UZ Brussel
UCL Saint Luc
CHR Saint Joseph Warquignies
UZ Gent
UCL Mont Godinne
Clinique du Parc Léopold
UZ Leuven
Private practice
AZ Sint Lucas
CHU Ambroise Paré
CHU Sart-Tilman
CHRU Lille
CHRU Strasbourg
CH Luxembourg
CHR Citadelle
CHU Reims
Hôpital Saint Vincent de Paul


title: Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease

summary: The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

ReferenceCitation: Antonini A, Bauer L, Dohin E, Oertel WH, Rascol O, Reichmann H, Schmid M, Singh P, Tolosa E, Chaudhuri KR. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015 Oct;22(10):1400-7. doi: 10.1111/ene.12757. Epub 2015 Jun 22.

location_country:
Romania
Spain
Italy
Austria
Czech Republic
Switzerland
Hungary
France
Belgium
Germany
Bulgaria
Slovakia

intervention_type: Other


title: Empirical Versus Pre-emptive (Diagnostic-driven) Antifungal Therapy of Patients Treated for Haematological Malignancies or Receiving an Allogeneic Stem Cell Transplant. A Therapeutic Open Label Phase III Strategy Study of the EORTC Infectious Diseases and Leukemia Groups

summary:
RATIONALE: Caspofungin acetate may be effective in treating fungal infections in patients with acute myeloid leukemia or myelodysplastic syndrome who are receiving treatment for their cancer. It is not yet known whether caspofungin acetate is more effective when treatment starts after development of a fever or after the infection is shown in laboratory test, chest x-ray, or CT scan.

PURPOSE: This randomized phase III trial is studying the best time to start caspofungin acetate therapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed or in first relapse.

primary_purpose: Supportive Care

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Netherlands France Belgium Germany Slovakia Czechia

location_facility: Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II

location_facility: Radboud University Nijmegen Medical Centre


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

acronym: EMPOWER

summary: The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

ReferenceCitation: Cudkowicz ME, van den Berg LH, Shefner JM, Mitsumoto H, Mora JS, Ludolph A, Hardiman O, Bozik ME, Ingersoll EW, Archibald D, Meyers AL, Dong Y, Farwell WR, Kerr DA; EMPOWER investigators. Dexpramipexole versus placebo for patients with amyotrophic lateral sclerosis (EMPOWER): a randomised, double-blind, phase 3 trial. Lancet Neurol. 2013 Nov;12(11):1059-67. doi: 10.1016/S1474-4422(13)70221-7. Epub 2013 Sep 23. Erratum in: Lancet Neurol. 2013 Nov;12(11):1042. Carbonell, J G [corrected to Gamez, J].

lead_sponsor: Knopp Biosciences

location_country:
Spain
Ireland
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Johns Hopkins University School of Medicine

location_facility: Washington University School of Medicine

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Research Foundation of the State University of New York

location_facility: University of Arkansas for Medical Sciences

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of Texas Health Sciences Center

location_facility: University of South Florida Medical Center

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: University of California at San Francisco - Fresno

location_facility: Walton Centre for Neurology & Neurosurgery


title: INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

summary:
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

ReferenceCitation: Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.

location_country:
New Zealand
Germany
United States
France


title: Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Kolotkin RL, Fujioka K, Wolden ML, Brett JH, Bjorner JB. Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management. Clin Obes. 2016 Aug;6(4):233-42. doi: 10.1111/cob.12146. Epub 2016 May 19.

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422.

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. Epub 2016 Aug 2.

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjøth TV, Bjørn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

ReferenceCitation: Pi-Sunyer X, Astrup A, Fujioka K, Greenway F, Halpern A, Krempf M, Lau DC, le Roux CW, Violante Ortiz R, Jensen CB, Wilding JP; SCALE Obesity and Prediabetes NN8022-1839 Study Group. A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management. N Engl J Med. 2015 Jul 2;373(1):11-22. doi: 10.1056/NEJMoa1411892.

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. Review.

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjøth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

ReferenceCitation: le Roux CW, Astrup A, Fujioka K, Greenway F, Lau DCW, Van Gaal L, Ortiz RV, Wilding JPH, Skjøth TV, Manning LS, Pi-Sunyer X; SCALE Obesity Prediabetes NN8022-1839 Study Group. 3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial. Lancet. 2017 Apr 8;389(10077):1399-1409. doi: 10.1016/S0140-6736(17)30069-7. Epub 2017 Feb 23. Erratum in: Lancet. 2017 Apr 8;389(10077):1398.

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

ReferenceCitation: Kolotkin RL, Gabriel Smolarz B, Meincke HH, Fujioka K. Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity. Clin Obes. 2018 Feb;8(1):1-10. doi: 10.1111/cob.12226. Epub 2017 Oct 16.

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

ReferenceCitation: Williams DM, Staff M, Bain SC, Min T. Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity. touchREV Endocrinol. 2022 Mar;18(1):43-48. doi: 10.17925/EE.2022.18.1.43. Epub 2022 Mar 18. Review.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Brazil
Canada
Switzerland
Former Serbia and Montenegro
Hungary
Germany
Denmark
Ireland
Finland
France
Netherlands

summary:
This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America.

The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline.

Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).


acronym: TIS

title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients

lead_sponsor: Horizon Pharma USA, Inc.

ReferenceCitation: Elborn JS, Flume PA, Cohen F, Loutit J, VanDevanter DR. Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection. J Cyst Fibros. 2016 Sep;15(5):634-40. doi: 10.1016/j.jcf.2016.01.005. Epub 2016 Feb 28.

location_country:
United Kingdom
Ireland
United States
Israel
France
Germany

location_facility: Universitätsklinik Gießen und Marburg GmbH Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: CRCM adultes et enfants Service des maladies respiratoires et pédiatrie 1 CHU- Arnaud de Villeneuve

location_facility: Kinderärztliche Gemeinschaftspraxis Dr. H. E. Heuer, Dr. C. Runge, W. Sextro

location_facility: Ludwig-Maximilians Universität Klinikum Innenstadt

location_facility: Schneider Childrens Medical Center of Israel

location_facility: Dr. von Haunersches Kinderspital der Universität München Christiane Herzog Ambulanz

location_facility: Safra Childrens Hospital, Sheba Medical Center

location_facility: Katharina-Kasper Kliniken GmbH St. Elisabethen-Krankenhaus Medizinische Klinik

location_facility: CRCM adulte Hôpital Larrey-CHU de Toulouse

location_facility: Hôpital Pellegrin Enfants - CHU Bordeaux

location_facility: Universitätsklinik für Kinder- und Jugendmedizin

summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


title: A Randomized, Double-Blind Study of the Safety and Efficacy of GSK1349572 Plus Abacavir/Lamivudine Fixed-Dose Combination Therapy Administered Once Daily Compared to Atripla Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.

ReferenceType: background

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Walmsley S, Baumgarten A, Berenguer J, Felizarta F, Florence E, Khuong-Josses MA, Kilby JM, Lutz T, Podzamczer D, Portilla J, Roth N, Wong D, Granier C, Wynne B, Pappa K. Brief Report: Dolutegravir Plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy-Naive Patients: Week 96 and Week 144 Results From the SINGLE Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2015 Dec 15;70(5):515-9. doi: 10.1097/QAI.0000000000000790. Erratum in: J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):e33.

ReferenceCitation: Walmsley SL, Antela A, Clumeck N, Duiculescu D, Eberhard A, Gutiérrez F, Hocqueloux L, Maggiolo F, Sandkovsky U, Granier C, Pappa K, Wynne B, Min S, Nichols G; SINGLE Investigators. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med. 2013 Nov 7;369(19):1807-18. doi: 10.1056/NEJMoa1215541.

lead_sponsor: ViiV Healthcare

location_country:
Denmark
Romania
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
United States
France
Belgium
Germany


title: A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short-term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport and Dysport NG) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport NG Following Repeated Treatments of Subjects With Cervical Dystonia

summary: The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.

ReferenceCitation: Poewe W, Burbaud P, Castelnovo G, Jost WH, Ceballos-Baumann AO, Banach M, Potulska-Chromik A, Ferreira JJ, Bihari K, Ehler E, Bares M, Dzyak LA, Belova AN, Pham E, Liu WJ, Picaut P. Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized-controlled trial. Mov Disord. 2016 Nov;31(11):1649-1657. doi: 10.1002/mds.26760. Epub 2016 Sep 21.

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Poland
Portugal
Austria
Australia
Russian Federation
Ukraine
Hungary
France
Belgium
Germany
Czechia

location_facility: Ukrainian State Institute of Medical and Social Problems of Disability

location_facility: Jósa András Oktató Kórház Nonprofit Kft.

location_facility: Institute of Neurology, Psychiatry and Narcology AMS of Ukraine

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Research Medical Complex "Vashe Zdorovie"

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: Department of Neurosciences Alfred Hospital

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Smolensk State Medical Academy Smolensk Regional Clinical Hospital

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Nizhniy Novgorod Research Institute for Traumatology and Orthopaedics

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Russian Medical Military Academy n.a. S.M.Kirov


title: A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection

summary: To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

ReferenceCitation: Dore GJ, Lawitz E, Hézode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Lédinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.

location_country:
Denmark
Italy
Australia
Canada
United States
France

location_facility:
California Liver Institute
Alamo Medical Research
Options Health Research, Llc
Local Institution
Digestive Disease Associates, P.A.


title: A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta

acronym: TERACLES

summary:
The primary objective was to demonstrate the effect of teriflunomide, in comparison to placebo, on frequency of Multiple Sclerosis (MS) relapses in patients with relapsing forms of MS who are treated with Interferon-beta (IFN-beta).

The secondary objectives were:

Assess the effect of teriflunomide, in comparison to placebo, when added to IFN-beta on:

Disease activity as measured by brain Magnetic Resonance Imaging (MRI)
Disability progression
Burden of disease and disease progression as measured by brain MRI
Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
Assess associations between variations in genes and clinical outcomes (safety and efficacy)
Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
Assess measures of health economics (hospitalization due to relapse, including the length of stay and any admission to intensive care unit)

status: Terminated

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Portugal
Austria
Australia
Russian Federation
Argentina
Tunisia
Norway
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Greece
Estonia
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Investigational Site Number 276023
Investigational Site Number 056002
Investigational Site Number 840027
Investigational Site Number 276009
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 840012
Investigational Site Number 840028
Investigational Site Number 380012
Investigational Site Number 840040
Investigational Site Number 032003
Investigational Site Number 380003
Investigational Site Number 152005
Investigational Site Number 840030
Investigational Site Number 276018
Investigational Site Number 440002
Investigational Site Number 643012
Investigational Site Number 056005
Investigational Site Number 380010
Investigational Site Number 643010
Investigational Site Number 276013
Investigational Site Number 170007
Investigational Site Number 276031
Investigational Site Number 643007
Investigational Site Number 840055
Investigational Site Number 840013
Investigational Site Number 036010
Investigational Site Number 170005
Investigational Site Number 643016
Investigational Site Number 724005
Investigational Site Number 528006
Investigational Site Number 620004
Investigational Site Number 724003
Investigational Site Number 826001
Investigational Site Number 788002
Investigational Site Number 643009
Investigational Site Number 528001
Investigational Site Number 528005
Investigational Site Number 724009
Investigational Site Number 620003
Investigational Site Number 276012
Investigational Site Number 124001
Investigational Site Number 056007
Investigational Site Number 440004
Investigational Site Number 724004
Investigational Site Number 076009
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 643014
Investigational Site Number 250001
Investigational Site Number 124006
Investigational Site Number 056004
Investigational Site Number 643018
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 380014
Investigational Site Number 348009
Investigational Site Number 788006
Investigational Site Number 276022
Investigational Site Number 032004
Investigational Site Number 036008
Investigational Site Number 840004
Investigational Site Number 703001
Investigational Site Number 348003
Investigational Site Number 788005
Investigational Site Number 276005
Investigational Site Number 840033
Investigational Site Number 246001
Investigational Site Number 643013
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 348010
Investigational Site Number 826004
Investigational Site Number 840046
Investigational Site Number 276016
Investigational Site Number 076007
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 840003
Investigational Site Number 233001
Investigational Site Number 246006
Investigational Site Number 276001
Investigational Site Number 152003
Investigational Site Number 276021
Investigational Site Number 124005
Investigational Site Number 246003
Investigational Site Number 840037
Investigational Site Number 840041
Investigational Site Number 276015
Investigational Site Number 840047
Investigational Site Number 076012
Investigational Site Number 208002
Investigational Site Number 788004
Investigational Site Number 643011
Investigational Site Number 826006
Investigational Site Number 380009
Investigational Site Number 643003
Investigational Site Number 380011
Investigational Site Number 233002
Investigational Site Number 528002
Investigational Site Number 840020
Investigational Site Number 246002
Investigational Site Number 032002
Investigational Site Number 380006
Investigational Site Number 124009
Investigational Site Number 276008
Investigational Site Number 840031
Investigational Site Number 410001
Investigational Site Number 643017
Investigational Site Number 276004
Investigational Site Number 578002
Investigational Site Number 348005
Investigational Site Number 840007
Investigational Site Number 410004
Investigational Site Number 840011
Investigational Site Number 170001
Investigational Site Number 380004
Investigational Site Number 276026
Investigational Site Number 276024
Investigational Site Number 124003
Investigational Site Number 752003
Investigational Site Number 840015
Investigational Site Number 056006
Investigational Site Number 826008
Investigational Site Number 276006
Investigational Site Number 276002
Investigational Site Number 380008
Investigational Site Number 276020
Investigational Site Number 724007
Investigational Site Number 840017
Investigational Site Number 620001
Investigational Site Number 250010
Investigational Site Number 840016
Investigational Site Number 040004
Investigational Site Number 380002
Investigational Site Number 620002
Investigational Site Number 040001
Investigational Site Number 840036
Investigational Site Number 076003
Investigational Site Number 752001
Investigational Site Number 300003
Investigational Site Number 152004
Investigational Site Number 410002
Investigational Site Number 826005
Investigational Site Number 300002
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840021
Investigational Site Number 124008
Investigational Site Number 840034
Investigational Site Number 276010
Investigational Site Number 246004
Investigational Site Number 643015
Investigational Site Number 348002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 840043
Investigational Site Number 300006
Investigational Site Number 643005
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 348007
Investigational Site Number 076013
Investigational Site Number 170009
Investigational Site Number 348006
Investigational Site Number 724001
Investigational Site Number 124007
Investigational Site Number 036005
Investigational Site Number 752004
Investigational Site Number 643001
Investigational Site Number 643004
Investigational Site Number 056001
Investigational Site Number 840049
Investigational Site Number 300001
Investigational Site Number 703002
Investigational Site Number 348001
Investigational Site Number 276028
Investigational Site Number 056003
Investigational Site Number 840005
Investigational Site Number 036004
Investigational Site Number 440003
Investigational Site Number 276032
Investigational Site Number 380005

status_simplified: Unknown


acronym: STRIDE

title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Romania
Slovenia
Greece
Austria
Ireland
Italy
Finland
Spain
United Kingdom
Hungary
France
Belgium
Netherlands
Slovakia
Czechia

summary: In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.


title: Phase III, Multi-center, Randomized, 12-week, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of RO4917838 in Patients With Sub-optimally Controlled Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 40-week Double-blind, Parallel-group, Placebo-controlled Treatment Period.

summary: This randomized, multi-center, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.

ReferenceCitation: Bugarski-Kirola D, Iwata N, Sameljak S, Reid C, Blaettler T, Millar L, Marques TR, Garibaldi G, Kapur S. Efficacy and safety of adjunctive bitopertin versus placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics: results from three phase 3, randomised, double-blind, parallel-group, placebo-controlled, multicentre studies in the SearchLyte clinical trial programme. Lancet Psychiatry. 2016 Dec;3(12):1115-1128. doi: 10.1016/S2215-0366(16)30344-3. Epub 2016 Nov 2.

lead_sponsor: Hoffmann-La Roche

location_country:
Romania
United Kingdom
Russian Federation
Australia
Mexico
Finland
Argentina
Hungary
Korea, Republic of
United States
France
India
Colombia
Sweden


title: A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

acronym: ZORO

summary: The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

ReferenceCitation: Marty FM, Vidal-Puigserver J, Clark C, Gupta SK, Merino E, Garot D, Chapman MJ, Jacobs F, Rodriguez-Noriega E, Husa P, Shortino D, Watson HA, Yates PJ, Peppercorn AF. Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial. Lancet Respir Med. 2017 Feb;5(2):135-146. doi: 10.1016/S2213-2600(16)30435-0. Epub 2017 Jan 14.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
United Kingdom
United States
Belgium
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
India
Mexico
Norway
Slovakia
Brazil
Canada
Hungary
China
Germany
Denmark
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France
Colombia
Netherlands


title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults With Partial -Onset Seizures

acronym: IR

summary: The purpose of this Phase III study is to evaluate the efficacy, safety and tolerability and health outcomes of retigabine Immediate Release (IR) as adjunctive therapy to each of the following monotherapy Antiepileptic Drug (AED) treatments: carbamazepine/oxcarbazepine, lamotrigine, levetiracetam, or valproic acid in adult subjects with partial-onset seizures (POS) using a flexible dosing regimen.

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Netherlands
Thailand
Ukraine
France
Belgium
Germany
Bulgaria