title: A Phase III Double-blind, Extension, Placebo-controlled Parallel Group Safety and Efficacy Trial of BI 10773 (10 and 25mg Once Daily) and Sitagliptin (100mg Once Daily) Given for Minimum 76 Weeks (Incl. 24 Weeks of Preceding Trial) as Monotherapy or With Different Back-ground Therapies in Patients With Type 2 Diabetes Mellitus Previously Completing Trial 1245.19, 1245.20 or 1245.23

summary: This study will investigate the efficacy and long term safety and tolerability of BI 10773 in type 2 diabetic patients.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Inzucchi SE, Davies MJ, Khunti K, Trivedi P, George JT, Zwiener I, Johansen OE, Sattar N. Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add-on to metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Feb;23(2):425-433. doi: 10.1111/dom.14234. Epub 2020 Nov 20.

ReferenceCitation: Shiba T, Ishii S, Okamura T, Mitsuyoshi R, Pfarr E, Koiwai K. Efficacy and safety of empagliflozin in Japanese patients with type 2 diabetes mellitus: A sub-analysis by body mass index and age of pooled data from three clinical trials. Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.

ReferenceCitation: Roden M, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Stella P, Woerle HJ, Broedl UC; EMPA-REG EXTEND™ MONO investigators. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug-naïve patients with type 2 diabetes: a double-blind extension of a Phase III randomized controlled trial. Cardiovasc Diabetol. 2015 Dec 23;14:154. doi: 10.1186/s12933-015-0314-0.

ReferenceCitation: Haering HU, Merker L, Christiansen AV, Roux F, Salsali A, Kim G, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG EXTEND™ METSU investigators. Empagliflozin as add-on to metformin plus sulphonylurea in patients with type 2 diabetes. Diabetes Res Clin Pract. 2015 Oct;110(1):82-90. doi: 10.1016/j.diabres.2015.05.044. Epub 2015 May 29.

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Slovenia
Greece
Ireland
Mexico
Canada
Switzerland
Ukraine
Philippines
Korea, Republic of
United States
France
China
India
Belgium
Japan
Germany
Turkey
Slovakia

location_facility: 1245.31.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86042 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20040 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33016 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86035 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20019 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10077 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86054 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10162 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91103 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32024 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86058 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86049 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32021 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86056 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86032 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33019 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86020 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20027 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86052 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10127 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86057 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10059 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10038 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10137 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49020 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35306 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10155 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86038 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10112 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35302 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49022 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49007 Boehringer Ingelheim Investigational Site

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location_facility: 1245.31.49002 Boehringer Ingelheim Investigational Site

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location_facility: 1245.31.86033 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86007 Boehringer Ingelheim Investigational Site

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location_facility: 1245.31.91104 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86043 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20032 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91101 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88013 Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: 1245.31.86016 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20022 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10131 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10156 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86039 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33020 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10146 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88021 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10157 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10158 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81013 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20041 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20021 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33013 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86019 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86045 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20030 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35303 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10119 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32016 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86013 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35305 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10046 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91105 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10123 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10151 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10130 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20035 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20057 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32025 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49016 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86031 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10117 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86055 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86036 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49017 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.88006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32026 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10159 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20036 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10154 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32020 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20060 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.81008 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20028 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82011 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20029 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20017 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10045 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20034 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49019 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10149 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10124 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86034 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33045 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49013 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.90001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.35304 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20033 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20025 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86017 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10080 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20058 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10133 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.33002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20016 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.30004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20005 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86053 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.41003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86041 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20024 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.75002 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32023 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91012 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10108 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20015 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10086 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20038 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10085 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.91014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.41004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.74004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10071 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49006 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10129 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86014 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86018 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.49009 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.63004 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.32019 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.10145 Boehringer Ingelheim Investigational Site

location_facility: 1245.31.86037 Boehringer Ingelheim Investigational Site


type: Other Identifier

title: A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics

acronym: PALMFlexS

summary: This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Schreiner A, Bergmans P, Cherubin P, Keim S, Rancans E, Bez Y, Parellada E, Carpiniello B, Vidailhet P, Hargarter L. A prospective flexible-dose study of paliperidone palmitate in nonacute but symptomatic patients with schizophrenia previously unsuccessfully treated with oral antipsychotic agents. Clin Ther. 2014 Oct 1;36(10):1372-88.e1. doi: 10.1016/j.clinthera.2014.08.014. Epub 2014 Oct 23. Erratum in: Clin Ther. 2014 Nov 1;36(11):1705.

lead_sponsor: Janssen-Cilag International NV

location_country:
Denmark
Croatia
Portugal
Spain
Greece
Austria
Estonia
Latvia
Lithuania
Netherlands
Switzerland
Ukraine
Sweden
Hungary
France
Israel
Turkey
United Kingdom
Belgium
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of ARQ197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer (NSCLC)

summary: This study is to determine if the combination regimen of tivantinib with erlotinib will improve overall survival relative to erlotinib alone in subjects with locally advanced or metastatic non-squamous, non-small cell lung cancer who have received 1 or 2 prior systemic anti-cancer therapies.

study_start_date_type: Actual

status: Terminated

design_allocation: Randomized

ReferenceCitation: Scagliotti G, von Pawel J, Novello S, Ramlau R, Favaretto A, Barlesi F, Akerley W, Orlov S, Santoro A, Spigel D, Hirsh V, Shepherd FA, Sequist LV, Sandler A, Ross JS, Wang Q, von Roemeling R, Shuster D, Schwartz B. Phase III Multinational, Randomized, Double-Blind, Placebo-Controlled Study of Tivantinib (ARQ 197) Plus Erlotinib Versus Erlotinib Alone in Previously Treated Patients With Locally Advanced or Metastatic Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Aug 20;33(24):2667-74. doi: 10.1200/JCO.2014.60.7317. Epub 2015 Jul 13.

ReferenceCitation: Scagliotti GV, Novello S, Schiller JH, Hirsh V, Sequist LV, Soria JC, von Pawel J, Schwartz B, Von Roemeling R, Sandler AB. Rationale and design of MARQUEE: a phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):391-5. doi: 10.1016/j.cllc.2012.01.003. Epub 2012 Mar 21.

ipd_sharing: No

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Denmark
France
Chile
Netherlands

status_simplified: Unknown


title: A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

summary: To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

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: Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, Mamolo C. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1753-1759. doi: 10.1111/jdv.13702. Epub 2016 Jun 7.

ReferenceCitation: Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, Yakusevich V, Chimenti S, Papacharalambous J, Proulx J, Gupta P, Tan H, Tawadrous M, Valdez H, Wolk R; OPT Compare Investigators. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015 Aug 8;386(9993):552-61. doi: 10.1016/S0140-6736(14)62113-9. Epub 2015 Jun 4.

lead_sponsor: Pfizer

location_country:
Croatia
Spain
United Kingdom
Belgium
Czechia
Poland
Hong Kong
Austria
Russian Federation
Argentina
Israel
Turkey
Singapore
Sweden
Slovakia
Bosnia and Herzegovina
Switzerland
Hungary
Germany
Bulgaria
Denmark
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: MBAL na Voennomeditsinska akademia- Sofia

location_facility: Department of Dermatology, Aarhus University Hospital

location_facility: Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

location_facility: Clinical hospital of emergency care N.V. Soloviev

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

location_facility: Centro de Investigacion Clinica de la Universidad del Rosario

location_facility: Department for skin and venerial diseases, Clinical Center University of Sarajevo

location_facility: State Research Center of Dermatovenerology, Department of dermatology

location_facility: Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

location_facility: Ryazan regional clinical dermatovenerologic dispensary

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: IMAI (Instituto Medico de Asistencia e Investigaciones)

location_facility: Department of dermatovenerology, University Hospital Center Zagreb

location_facility: LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

location_facility: Tsentar za kozhno-venericheski zaboliavania" EOOD

location_facility: Novum Instytut Dermatologii Leczniczej i Estetycznej

location_facility: Skanes Universitetssjukhus i Malmo, Hudkliniken

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

location_facility: Samsung Medical Center / Department of Dermatology

location_facility: Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

location_facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Centro Integral de Reumatología del Caribe Circaribe S.A

location_facility: Hospital General Universitario de Alicante

location_facility: LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

location_facility: Hautarztpraxis Dres. Scholz, Sebastian, Schilling

location_facility: Hospital Clinico Universidad de Chile, Departamento Dermatologia

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: LKH Salzburg, Landesklinik fuer Dermatologie

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

location_facility: Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

location_facility: T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

location_facility: Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

location_facility: Hôpital de Brabois / Bâtiment Philippe Canton

location_facility: Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

location_facility: Amphia Hospital Location Molengracht / Department Dermatology

location_facility: Severance Hospital, Yonsei University College of Medicine/Department of Dermatology

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

location_facility: Dres.Kirsten Prepeneit und Volker Streit

location_facility: Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

location_facility: Kralska zdravotni a.s., Masarykovy nemocnice o.z.

location_facility: Istanbul university Istanbul Medical Faculty

location_facility: SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

location_facility: NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

location_facility: Centro de Investigaciones Dermatologicas

location_facility: Department of Dermatovenerology, University Hospital Center Osijek

location_facility: DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

location_facility: Hopital Ambroise Pare, Service de Dermatologie

location_facility: State Research Center of Dermatovenerology, Department of clinical dermatology

location_facility: Rostov-on-Don regional dermatovenerologic dispensary

location_facility: Dermatovenerologic dispensary #10 of Vyborg region

intervention_type: Biological


title: Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine

acronym: ONTIME

summary: The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.

ReferenceType: background

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

ReferenceCitation: Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Cell. 2016 Apr 21;165(3):643-55. doi: 10.1016/j.cell.2016.03.045.

ReferenceType: result

ReferenceCitation: Garcia-Manero G, Fenaux P, Al-Kali A, Baer MR, Sekeres MA, Roboz GJ, Gaidano G, Scott BL, Greenberg P, Platzbecker U, Steensma DP, Kambhampati S, Kreuzer KA, Godley LA, Atallah E, Collins R Jr, Kantarjian H, Jabbour E, Wilhelm FE, Azarnia N, Silverman LR; ONTIME study investigators. Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): a randomised, controlled, phase 3 trial. Lancet Oncol. 2016 Apr;17(4):496-508. doi: 10.1016/S1470-2045(16)00009-7. Epub 2016 Mar 9.

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15. Review.

ReferenceCitation: Al-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

lead_sponsor: Onconova Therapeutics, Inc.

location_country:
Spain
Italy
United States
France
Belgium
Germany

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Emory University Winship Cancer Institute

location_facility: CHU Perpignan Centre Hospitalier Hôpital Saint-Jean

location_facility: University of California San Diego Moores Cancer Center

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Azienda Osperdaliera Universitaria Maggiore della Carità

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Mount Sinai Comprehensive Cancer Centers

location_facility: University of Oklahoma Health Science Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi di Firenze

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: Azienda Ospedaliero-Universitaria di Bologa Policlinico S. Orsola-Malpighi

location_facility: CHU Avignon Centre Hospitalier Henri Dufaut

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: University of Pennsylvania Health System

location_facility: Azienda Ospedaliera-Universitairia Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: CHU Angers Service de Medecine D - Maladies du Sang

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliero Universitaria San Giovanni Battista di Torino

location_facility: Hospital Universitario Central de Asturias

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: University of Texas M. D. Anderson Cancer Center


title: An Observational Study of the Treatment of Multiple Myeloma in Routine Clinical Practice

summary: The primary objective of this observational study is to document and describe current treatment regimens and disease progression of patients with Multiple Myeloma (MMY). The aim of this registry is to provide accurate, descriptive information on the way Multiple Myeloma is treated in routine clinical practice. The registry will collect information related to the treatment received for Multiple Myeloma. About 3000 patients will take part in the study in about 28 countries. The registry will only collect information that is already in medical files regarding treatment. Patients will not be required to actively do anything in addition to what would be done without participating in this registry, nor will there be any procedures or interventions that are not already part of the current treatment.

study_type: Observational

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country: Macedonia, The Former Yugoslav Republic of

intervention_type: Other


title: Edwards SAPIEN™ Aortic Bioprosthesis Multi-Region Outcome Registry XT

summary: This registry is to expand upon existing data sets, to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis that are undergoing treatment with the commercially available Edwards SAPIEN XT™ Valve, and delivery devices.

time_perspective: Prospective

ReferenceCitation: Schymik G, Lefèvre T, Bartorelli AL, Rubino P, Treede H, Walther T, Baumgartner H, Windecker S, Wendler O, Urban P, Mandinov L, Thomas M, Vahanian A. European experience with the second-generation Edwards SAPIEN XT transcatheter heart valve in patients with severe aortic stenosis: 1-year outcomes from the SOURCE XT Registry. JACC Cardiovasc Interv. 2015 Apr 27;8(5):657-69. doi: 10.1016/j.jcin.2014.10.026.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
Poland
Spain
Greece
Austria
Italy
Netherlands
Canada
Finland
Switzerland
United Kingdom
France
Israel
South Africa
Belgium
Norway
Germany
Czechia

location_facility: Centre Hospitalier De Universite of Montreal

location_facility: The Cardinal Stefan Wyszyński Institute of Cardiology

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Azienda Ospedaliera Policlinico Universitario

location_facility: CHU Montpellier - Hôpital Arnaud de Villeneuve

location_facility: KLINIKUM KARLSBURG der Klinikgruppe Dr. Guth GmbH & Co. KG

location_facility: St Mary's Hospital - Imperial College Healthcare NHS Trust, Hammersmith Hospital . Du Cane Road

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

location_facility: Klinikum der Universität München - Großhadern

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Complexo Hospitalario Universitario de Vigo

intervention_type: Device


ipd_sharing: Yes

title: A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

lead_sponsor: Novartis Pharmaceuticals

source: euctr

ReferenceCitation: Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.

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

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Panama
Turkey
Norway
Malaysia
Sweden
Slovakia
Egypt
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Denmark
Jordan
Greece
Ireland
Estonia
Finland
Korea, Republic of
France
Netherlands

summary: The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.


title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel Plus Prednisone With Placebo Plus Prednisone in Patients With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

lead_sponsor: Millennium Pharmaceuticals, Inc.

type: Registry Identifier

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

ReferenceCitation: Saad F, Fizazi K, Jinga V, Efstathiou E, Fong PC, Hart LL, Jones R, McDermott R, Wirth M, Suzuki K, MacLean DB, Wang L, Akaza H, Nelson J, Scher HI, Dreicer R, Webb IJ, de Wit R; ELM-PC 4 investigators. Orteronel plus prednisone in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (ELM-PC 4): a double-blind, multicentre, phase 3, randomised, placebo-controlled trial. Lancet Oncol. 2015 Mar;16(3):338-48. doi: 10.1016/S1470-2045(15)70027-6. Epub 2015 Feb 18.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Mexico
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Germany
Bulgaria
Taiwan
Belarus
Greece
Ireland
Latvia
New Zealand
Finland
Czech Republic
France
Chile
Colombia
Netherlands

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel (TAK-700) plus prednisone compared with placebo plus prednisone in the treatment of men with progressive, chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC)


title: A MultiCentre, Randomized, Double-blind, Placebo-controlled Phase IIb Study to Compare the Efficacy and Safety of Two Dosing Regimens of Intravenous Infusions of AZD9773 (CytoFab™) in Adult Patients With Severe Sepsis and/or Septic Shock

summary: The primary purpose of this study to evaluate the effect of two different doses of AZD9773 (CytoFab™) versus placebo on ventilator free days (VFDs) over the first 28 days after the start of dosing with AZD9773 in patients with severe sepsis and/or septic shock, who are already receiving appropriate standard of care treatment for sepsis.

ReferenceCitation: Yates JW, Das S, Mainwaring G, Kemp J. Population pharmacokinetic/pharmacodynamic modelling of the anti-TNF-α polyclonal fragment antibody AZD9773 in patients with severe sepsis. J Pharmacokinet Pharmacodyn. 2012 Dec;39(6):591-9. doi: 10.1007/s10928-012-9270-4. Epub 2012 Sep 23.

lead_sponsor: AstraZeneca

location_country:
Spain
Australia
Finland
Canada
Czech Republic
France
Belgium