title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and Either Emtricitabine/Tenofovir Alafenamide or Emtricitabine/Tenofovir Disoproxil Fumarate to a Fixed Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Subjects Who Are Virologically Suppressed

lead_sponsor: Gilead Sciences

ReferenceCitation: Sax PE, Rockstroh JK, Luetkemeyer AF, Yazdanpanah Y, Ward D, Trottier B, Rieger A, Liu H, Acosta R, Collins SE, Brainard DM, Martin H; GS-US-380-4030 Investigators. Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clin Infect Dis. 2021 Jul 15;73(2):e485-e493. doi: 10.1093/cid/ciaa988.

ReferenceCitation: Acosta RK, Willkom M, Andreatta K, Liu H, Martin R, Parvangada A, Martin H, Collins S, White KL. Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) From Dolutegravir (DTG)+F/TAF or DTG+F/Tenofovir Disoproxil Fumarate (TDF) in the Presence of Pre-existing NRTI Resistance. J Acquir Immune Defic Syndr. 2020 Nov 1;85(3):363-371. doi: 10.1097/QAI.0000000000002454.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

location_country:
Austria
Canada
Puerto Rico
United States
France
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Abbott Northwestern Hospital part of Allina Health

location_facility: Universitätsklinikum Hamburg- Eppendorf - Ambulanzzentrum des Universitatsklinikums Eppendorf GmbH - Bereich Infektiologie

location_facility: Prime Healthcare Services - St. Michael's LLC d/b/a Saint Michael's Medical Center

location_facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Klinisches Studienzentrum Immunologie

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: Infectious Disease Research Institute Inc

location_facility: Hennepin County Medical Center, Positive Care Clinic

location_facility: AIDS Arms Inc/ Trinity Health and Wellness Center

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: Community Research Initiative of New England

location_facility: Chronical Viral Illness Service/McGill University Health Care (MUHC)

location_facility: AIDS Healthcare Foundation - South Beach

location_facility: Universitätsklinikum Frankfurt, Medizinische Klinik II, Schwerpunkt Infektiologie, Haus 68

location_facility: Mercer University, Department of Internal Medicine

location_facility: Kaiser Permanente, Department of Infectious Diseases

location_facility: Medical University of South Carolina (MUSC)

location_facility: NC TraCS Institute - CTRC; University of North Carolina at Chapel Hill

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie

location_facility: East Carolina University (ECU), The Brody School of Medicine, Adult Specialty Care

location_facility: University of Miami Divison of Infectious Diseases Clinical Research Unit

location_facility: Clinique de Médecine Urbaine du Quartier Latin

location_facility: EPIMED Gesellschaft fur epidemiologische und klinische Forschung in der Medizin mbH

location_facility: North Texas Infectious Diseases Consultants, P.A.

location_facility: Maple Leaf Research / Maple Leaf Medical Clinic

location_facility: Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: zibp Zentrum für Infektiologie Berlin Prenzlauer Berg

location_facility: The Crofoot Research Center, INC (DBA: Gordon E. Crofoot MD PA)

location_facility: Palmetto Health Richland (Regulatory and Study Supply Shipping)

location_facility: Universitätsklinikum Essen - Klinik fur Dermatologie und Venerologie - HPSTD Ambulanz

location_facility: John A. Burns School of Medicine, University of Hawaii Clinics at Kaka'ako

location_facility: Providence Hospital Center for Infectious Diseases

location_facility: University of Colorado Denver, University of Colorado Hospital

location_facility: Highland Hospital - Alameda Health System

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: AIDS Research and Treatment Center of the Treasure Coast

location_facility: Hôpital Gui de Chauliac, CHU de Montpellier

location_facility: Claudia T Martorell, MD., LLC d/b/a The Research Institute

location_facility: MultiCare Rockwood HIV Critical Care Clinic

location_facility: Universitätsklinikum Köln - Klinik I fur Innere Medizin - Klinisches Studienzentrum fur Infektiologie I

location_facility: Midland Florida Clinical Research Center, LLC

summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (DTG) and emtricitabine /tenofovir alafenamide (F/TAF) or DTG and emtricitabine/tenofovir disoproxil fumarate (F/TDF) to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus DTG+F/TAF in virologically suppressed HIV-1 infected adults with or without antiretroviral (ARV) resistance.


title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

summary:
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: derived

ReferenceCitation: Yun MR, Kim DH, Kim SY, Joo HS, Lee YW, Choi HM, Park CW, Heo SG, Kang HN, Lee SS, Schoenfeld AJ, Drilon A, Kang SG, Shim HS, Hong MH, Cui JJ, Kim HR, Cho BC. Repotrectinib Exhibits Potent Antitumor Activity in Treatment-Naïve and Solvent-Front-Mutant ROS1-Rearranged Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Jul 1;26(13):3287-3295. doi: 10.1158/1078-0432.CCR-19-2777. Epub 2020 Apr 8.

ReferenceCitation: Drilon A, Ou SI, Cho BC, Kim DW, Lee J, Lin JJ, Zhu VW, Ahn MJ, Camidge DR, Nguyen J, Zhai D, Deng W, Huang Z, Rogers E, Liu J, Whitten J, Lim JK, Stopatschinskaja S, Hyman DM, Doebele RC, Cui JJ, Shaw AT. Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor That Potently Inhibits ROS1/TRK/ALK Solvent- Front Mutations. Cancer Discov. 2018 Oct;8(10):1227-1236. doi: 10.1158/2159-8290.CD-18-0484. Epub 2018 Aug 9.

ipd_sharing: No

ipd_sharing_description: There are no plans to share individual participant data with other researchers.

lead_sponsor: Turning Point Therapeutics, Inc.

location_country:
Denmark
Poland
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
China
Singapore
Belgium
Japan
Germany

location_facility: Vall d'Hebron University Hospital PHASE 2

location_facility: Centre Hospitalier Universitarie Arie Grenoble Alpes (CHUGA) PHASE 2

location_facility: Memorial Sloan Kettering Cancer Center PHASE 1 (recruiting) & PHASE 2 (Recruiting)

location_facility: MD Anderson Cancer Center - The University of Texas PHASE 2

location_facility: Országos Korányi TBC és Pulmonológiai Intézet Budapest PHASE 2

location_facility: Baptist Memorial Hospital Baptist Cancer Center PHASE 2

location_facility: Columbus Regional Research Institute PHASE 2

location_facility: The Center for Cancer & Blood Disorders - Maryland PHASE 2

location_facility: The First Affiliated Hospital of Gannan Medical University PHASE 2

location_facility: National Cancer Center Hospital, Tokyo PHASE 2

location_facility: Princess Margaret Cancer Center at University Health Network PHASE 2

location_facility: Sichuan Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: Georgetown Lombardi Comprehensive Cancer Center PHASE 2

location_facility: The First Affiliated Hospital Zhejiang University School of Medicine/Respiratory medicine Department PHASE 2

location_facility: Hopital D'Instruction Des Armees Begin PHASE 2

location_facility: National Cheng Kung University Hospital PHASE 2

location_facility: National Taiwan University Hospital PHASE 2

location_facility: Hong Kong United Oncology Centre PHASE 2

location_facility: Oklahoma Cancer Specialists and Research Institute Tulsa, OK (OCSRI) (QCCA) PHASE 2

location_facility: Weifang People's Hospital/Medical Oncology Department PHASE 2

location_facility: Instituto Valenciano de Oncología PHASE 2

location_facility: Guangdong Provincial People's Hospital PHASE 2

location_facility: Konkuk University Medical Center PHASE 2

location_facility: UZA Research Unit Oncology- route 55 PHASE 2

location_facility: IRCCS Istituto Regina Elena Oncologia Medica 1 PHASE 2

location_facility: Cancer Hospital Chinese Academy of Medical Sciences/Cancer Institute PHASE 2

location_facility: University of Colorado Denver PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: Avera Cancer Institute Center for Precision Oncology PHASE 2

location_facility: Washington University Siteman Cancer Center PHASE 2

location_facility: West China Hospital Sichuan University/Lung cancer center PHASE 2

location_facility: Centrum für Integrierte Onkologie - Universitaetsklinikum Koeln PHASE 2

location_facility: Zhejiang Cancer Hospital/Thoracic Oncology Department PHASE 2

location_facility: MGH Satellite - Dana-Farber Cancer Institute PHASE 2

location_facility: Anhui Provincial Hospital/Oncology Department PHASE 2

location_facility: Frederick Health - James M Stockman Cancer Institute PHASE 2

location_facility: Shanghai Chest Hospital/Chest Cancer Institute PHASE 2

location_facility: Rigshospitalet, University Hospital of Copenhagen PHASE 2

location_facility: Beijing Cancer Hospital/Oncology Department PHASE 2

location_facility: Centre Hospitalier Regional Vuniversitaire Brest PHASE 2

location_facility: University of Maryland School of Medicine PHASE 2

location_facility: XuZhou Central Hospital/Oncology Department PHASE 2

location_facility: Katedra i Klinika Pneumonologii, Onkologii i Alergologii Uniwersytetu Medycznego w Lublinie PHASE 2

location_facility: Seoul National University Hospital PHASE 2

location_facility: Ventura County Hematology Oncology Specialists PHASE 2

location_facility: The Third Xiangya Hospital of Central South University/Department of Respiratory and Critical Care Medicine PHASE 2

location_facility: The Royal Marsden NHS Foundation Trust PHASE 2

location_facility: Ohio State Wexner Medical Center PHASE 2

location_facility: Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology/Cancer Center Department PHASE 2

location_facility: Imperial College London - Hammersmith Hospital PHASE 2

location_facility: Fondazione IRCCS Istituto Nazionale Dei Tumori PHASE 2

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud PHASE 2

location_facility: National Cancer Center Hospital East PHASE 2

location_facility: Chonnam National University Hwasun Hospital PHASE 2

location_facility: Universiair Medisch Centrum Groningen PHASE 2

location_facility: New Jersey Cancer Care and Blood Disorders PHASE 2

location_facility: Hospital Universitario 12 de Octubre PHASE 2

location_facility: UC Irvine Health, Chao Family Comprehensive Cancer Center PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: Massachusetts General Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: University Cancer and Blood Center PHASE 2

location_facility: University Clinic Carl Gustav Carus PHASE 2

location_facility: Kanagawa Cancer Center, Yokohama PHASE 2

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine/Oncology Department PHASE 2

location_facility: National Cancer Center Singapore PHASE 2

location_facility: Maria Sklodowska-Curie Cancer Centre and Institute PHASE 2

location_facility: Fujian Provincial Cancer Hospital/Thoracic oncology Department PHASE 2

location_facility: Jilin Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: Yonsei Cancer Center, Severance Hospital PHASE 1 (recruiting) & PHASE 2 (recruiting)

location_facility: University of Michigan Rogel Cancer Center PHASE 2

location_facility: Hunan Cancer Hospital/Medical Oncology Department PHASE 2

location_facility: The Christie NHS Foundation Trust PHASE 2

location_facility: Daping Hospital, the Third Affiliated Hospital of Third Military Medical University /Cancer Center PHASE 2

location_facility: The First Hospital of Jilin University/Oncology Center Department PHASE 2

location_facility: Pontchartrain Cancer Center (QCCA) PHASE 2

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cerevello" PHASE 2

location_facility: Fort Wayne Medical Oncology and Hematology PHASE 2

location_facility: Hematology Oncology Associates of Fredericksburg PHASE 2

location_facility: Seoul National University Hospital PHASE 1 (recruiting) and PHASE 2 (not yet recruiting)

location_facility: Jinan Central Hospital/Medical Oncology Department PHASE 2

location_facility: Regions Hospital Cancer Care Center PHASE 2

location_facility: Johns Hopkins Kimmel Cancer Center PHASE 2

location_facility: Shanghai Chest Hospital/Oncology Department PHASE 2

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico PHASE 2

location_facility: The Affiliated Tumor Hospital of Harbin Medical University/Medical Oncology Department PHASE 2

location_facility: Henan Cancer Hospital/The 1st pneumology department PHASE 2

location_facility: The Second XIANGYA Hospital Of Central South University/Oncology Department PHASE 2

location_facility: The First Affiliated Hospital of Xiamen University/Medical oncology Department PHASE 2

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii PHASE 2

location_facility: Osaka International Cancer Institute PHASE 2

location_facility: Azienda Ospedaliera Santa Maria di Terni - PHASE 2

location_facility: Evangelische Lungenklinik Berlin PHASE 2

location_facility: Cancer Specialists of North Florida PHASE 2

location_facility: Chungbuk National University Hospital PHASE 2

location_facility: UC San Diego Moores Cancer Center PHASE 2

location_facility: The first Hospital Affiliated to AMU (Southwest Hospital)/Pneumology Department PHASE 2

location_facility: Southeastern Medical Oncology Center PHASE 2

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis

acronym: ECLIPSE

summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

ReferenceCitation: Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
Australia
Canada
Hungary
United States
France
Germany
Czechia

location_facility: Southern California Permanente Medical Group

location_facility: NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: San Luis Dermatology & Laser Clinic, Inc

location_facility: Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm

location_facility: Dermatology Clinical Research Center of San Antonio

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

location_facility: St George Dermatology & Skin Cancer Centre

location_facility: Atlanta Dermatology, Vein & Research Center

location_facility: Suzanne Bruce and Associates - The Center for Skin Research

status_simplified: Completed


title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

summary: This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

ReferenceCitation: Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grünwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Argentina
Israel
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Greece
Czech Republic
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: University of California at Los Angeles UCLA (4)

location_facility: University of Minnesota Medical Center - Fairview Univ of MN

location_facility: University of Maryland Medical Center UMMC

location_facility: Stanford University Medical Center Cancer Clinical Trials Office

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)

location_facility: Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

location_facility: University of Virginia Health Systems Univ Virginia

location_facility: Willamette Valley Clinical Studies Williamette Valley Cancer

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

location_facility: CINJ at Cooper University Hospital Cooper

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: Medical University of South Carolina -Hollings Cancer Center Med Univ SC

location_facility: University of Kansas Cancer Center Univ of KS

location_facility: University of Texas Southwestern Medical Center UTSW


title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY

acronym: PREVAIL

summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

ReferenceCitation: Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naïve men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.

ReferenceCitation: Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.

ReferenceCitation: Kim CS, Choi YD, Lee SE, Lee HM, Ueda T, Yonese J, Fukagai T, Chiong E, Lau W, Abhyankar S, Theeuwes A, Tombal B, Beer TM, Kimura G. Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer. Medicine (Baltimore). 2017 Jul;96(27):e7223. doi: 10.1097/MD.0000000000007223.

ReferenceCitation: Devlin N, Herdman M, Pavesi M, Phung, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. doi: 10.1186/s12955-017-0704-y.

ReferenceCitation: Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.

ReferenceCitation: Kim CS, Theeuwes A, Kwon DD, Choi YD, Chung BH, Lee HM, Lee KH, Lee SE. The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investig Clin Urol. 2016 May;57(3):174-83. doi: 10.4111/icu.2016.57.3.174. Epub 2016 May 10.

ReferenceCitation: Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW, Forer D, Parli T, Phung D, Tombal B, Beer TM, Sternberg CN. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Ann Oncol. 2016 Feb;27(2):286-94. doi: 10.1093/annonc/mdv542. Epub 2015 Nov 16.

ReferenceCitation: Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Poland
Austria
Australia
Russian Federation
Israel
Sweden
Singapore
Slovakia
Canada
Germany
Denmark
Finland
Korea, Republic of
France
Netherlands

location_facility: Centre Hospitalier Universitaire de Liege-Urologie

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: QEII Health Sciences Centre, Nova Scotia Cancer Centre.

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Royal North Shore Hospital, Department of Medical Oncology

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging

location_facility: British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior

location_facility: Azienda USL8-Presidio Ospedaliero S.Donato

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Oncology Eastern Clinical Research Unit (ECRU)

location_facility: University Medical Center Groningen, Department of Urology

location_facility: University College London Hospital NHS Trust

location_facility: Hematology / Oncology MUSC Hollings Cancer Center

location_facility: Centre de recherche clinique el evaluative en oncologie (CRCEO)

location_facility: Department of Urology, National University Hospital

location_facility: Centre Eugene Marquis-Service d'Oncologie Medicale

location_facility: Niigata University Medical and Dental Hospital

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Jewish Hospital & St. Mary's Healthcare, Inc.

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Lismore Base Hospital, Lismore Cancer Care and Haematology Unit

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

location_facility: Tom Baker Cancer Centre - Holy Cross Site

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: UROEXAM, spol. s r.o. urologicka ambulancia

location_facility: Clinical Investigations and Research Unit, Royal Sussex County Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Vrije Universiteit Medical Center, Department of Medical Oncology

location_facility: North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare

location_facility: Medical University of South Carolina - Urology Services

location_facility: Hospital Universitario German Trias i Pujol

location_facility: Universitaetsklinikum Heidelberg, Klinik Fuer Urologie

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: State Educational Institution of Higher Professional Education

location_facility: MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica

location_facility: Azienda Ospedaliera San. Camillo Forlanini

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden an der

location_facility: North County Oncology Medical Clinic, Inc

location_facility: University of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: The University of Arizona Cancer Certer-North Campus

location_facility: MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: HIA Begin, Service de Medecine Interne et Oncologie

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: University of Queensland Centre for Clinical Research (UQCCR)

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Division of Oncourology, National Cancer Institute

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi

location_facility: The Ottawa Hospital Cancer Centre, General Campus

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: London RegCancer Program, London Health Sciences Centre

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Universitaetsklinikum Mannheim, Klinik fuer Urologie

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)


title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

lead_sponsor: Amgen

source: euctr

ReferenceType: background

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhommé C, Richardson G, Rincón DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17.

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhommé C, Richardson G, Rincón DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18.

ReferenceCitation: Fujiwara K, Monk BJ, Lhommé C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
India
Israel
Mexico
Malaysia
Sweden
Brazil
Canada
Switzerland
Bulgaria
Greece
Latvia
Estonia
Czech Republic
Korea, Republic of
France
Chile

summary:
The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.


title: A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

summary: This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

status: Active, not recruiting

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: Butzkueven H, Spelman T, Horakova D, Hughes S, Solaro C, Izquierdo G, Kubala Havrdová E, Grand'Maison F, Prat A, Girard M, Hupperts R, Onofrj M, Lugaresi A, Taylor B; MSBase Study Group, Giovannoni G, Kappos L, Hauser SL, Montalban X, Craveiro L, Freitas R, Model F, Overell J, Muros-Le Rouzic E, Sauter A, Wang Q, Wormser D, Wolinsky JS. Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry. Eur J Neurol. 2022 Apr;29(4):1082-1090. doi: 10.1111/ene.14824. Epub 2021 May 6.

ReferenceCitation: Wolinsky JS, Arnold DL, Brochet B, Hartung HP, Montalban X, Naismith RT, Manfrini M, Overell J, Koendgen H, Sauter A, Bennett I, Hubeaux S, Kappos L, Hauser SL. Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2020 Dec;19(12):998-1009. doi: 10.1016/S1474-4422(20)30342-2. Epub 2020 Oct 29. Erratum in: Lancet Neurol. 2020 Nov 17;:.

ReferenceCitation: Fox EJ, Markowitz C, Applebee A, Montalban X, Wolinsky JS, Belachew S, Fiore D, Pei J, Musch B, Giovannoni G. Ocrelizumab reduces progression of upper extremity impairment in patients with primary progressive multiple sclerosis: Findings from the phase III randomized ORATORIO trial. Mult Scler. 2018 Dec;24(14):1862-1870. doi: 10.1177/1352458518808189. Epub 2018 Nov 12.

ReferenceCitation: Wolinsky JS, Montalban X, Hauser SL, Giovannoni G, Vermersch P, Bernasconi C, Deol-Bhullar G, Garren H, Chin P, Belachew S, Kappos L. Evaluation of no evidence of progression or active disease (NEPAD) in patients with primary progressive multiple sclerosis in the ORATORIO trial. Ann Neurol. 2018 Oct;84(4):527-536. doi: 10.1002/ana.25313.

ReferenceCitation: Montalban X, Hauser SL, Kappos L, Arnold DL, Bar-Or A, Comi G, de Seze J, Giovannoni G, Hartung HP, Hemmer B, Lublin F, Rammohan KW, Selmaj K, Traboulsee A, Sauter A, Masterman D, Fontoura P, Belachew S, Garren H, Mairon N, Chin P, Wolinsky JS; ORATORIO Clinical Investigators. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis. N Engl J Med. 2017 Jan 19;376(3):209-220. doi: 10.1056/NEJMoa1606468. Epub 2016 Dec 21.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Uruguay
Israel
Mexico
Norway
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Greece
New Zealand
Finland
France
Netherlands

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: Fakultni nemocnice Brno; Interni kardiologicka klinika

location_facility: Mount Sinai School of Medicine; Neurology

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Barzilai Medical Center; Neurology Department

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Rabin Medical Center; Multiple Sclerosis Clinic

location_facility: Klaipeda University Hospital; Public Institution

location_facility: Indiana University Medical Center; Department of Neurology

location_facility: Universität Leipzig; Innere Medizin, Neurologie, Dermatologie

location_facility: Wayne State University; Department of Neurology

location_facility: University of Miami School of Medicine; Dept. of Neurology Movement Disorder Center

location_facility: Swedish Neuroscience Institute; Multiple Sclerosis Center

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT

location_facility: Research Medical Complex "Vashe Zdorovie"; Neurology Department

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurologie

location_facility: Wellington Hospital; Department of Neurology

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: University of Colorado; Anschutz Medical Campus Department of Neurology

location_facility: Timisoara Emergency County Clinical Hospital

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

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Lviv Regional Clinical Hospital; Department of Neurology

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Washington University School of Medicine; Department of Neurology

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Intermedios y Urgencias Pediatricas

location_facility: Ukrainian State Inst. of Med. and Social Problems of Disability; Neuro

location_facility: Elias Emergency University Hospital Neurology Dept; Neurology Department

location_facility: Groupe Hospitalo-Universitaire Caremeau; Service Neurologie

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: University of Minnesota; Clin. Neuro Research Unit

location_facility: Royal Victoria Infirmary; Neurology Dept.

location_facility: Uni Hospital Queens Medical Centre; Neurology

location_facility: Univ of CA San Francisco; Department of Neurology

location_facility: Hopital Purpan; Fédération de neurologie

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology

location_facility: Hospital das Clinicas - UFG;Reumatologia

location_facility: Trustees of the University of Pennsylvania; Neurology

location_facility: Tampereen yliopisto; Kliinisen lääketieteen laitos, Neurologian yksikkö

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Centro de Estudios Clinicos y Espec. Med. SC

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Municipal Non-profit Enterprise Odessa Regional Clinical Hospital of Odessa Regional Council

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Vero Beach Neurology and Research Institute

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej; Neuro-Medic

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Hospital de Basurto; Servicio de Neurologia

location_facility: University of British Columbia UBC Hospital; Multiple Sclerosis (MS) Clinic - Vancouver

location_facility: Michigan Institute for Neurological Disorders

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Universitätsklinikum Gießen und Marburg GmbH; Neurologie

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: Klinikum Bayreuth GmbH; Neurologische Klinik

location_facility: Dnipropetrovsk State Medical Academy; Dept of Neurology

location_facility: Turku University Central Hospital; Pharmacy

location_facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council

location_facility: Weill Medical College of Cornell University; Judith Jaffe MS Ctr

location_facility: SPZOZ Uni. Szpital Kliniczny nr 1 im. Norberta Barlickiego Uni. Medycznego w Lodzi ; Neurologii

location_facility: Heinrich Heine Universität Düsseldorf; Neurologische Klinik

location_facility: Hospital Clinic i Provincial; Servicio de Neurologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hadassah University Hospital Ein Kerem; Neurology Department

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Montreal Neurological Institute and Hospital

location_facility: Kh. Med. Ac. of P.-Gr. Ed.; Cl. Cen. Hosp. of UkrZal.; 3rd Dept. Neurology

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: Medical Center Ziv Safed; Neurology Department

location_facility: St Vincent's Hospital Melbourne; Clinical Neuroscience and Neurological Research

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II

location_facility: Medizinische Universitat Wien Medical University of Vienna

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Instituto Nacional de Neurologia y Neurocirugia

location_facility: Medizinische Einrichtungen des Bezirks Oberpfalz GmbH; Neurologie

location_facility: Henry Ford Health System; Neurology & Neurosurgery

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Comprehensive MS Care Center at South Shore Neurologic Assoc.

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Vinnytsya National Med. Uni. n.a. M.I. Pyrohov; Dept. of Neurology #3

location_facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: University of New Mexico; MS Specialty Clinic

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Hospital Nacional Dos de Mayo - Centro de Investigacion en Oncología

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Akson - Clinical Research Maciejowski - Bielecki Sp. Jawna

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej KENDRON ; Poradnia Neurologiczna

location_facility: Kyiv City Clinical Hospital #4 MAHC of Kyiv; Chair of Neurology

location_facility: Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika

location_facility: Veszprém Megyei Csolnoky Ferenc Kórház; Reumatológia

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: Zespol Opieki Zdrowotnej w Konskich; Oddzial Neurologiczny

location_facility: Oslo universitetssykehus HF, Ullevål; Nevrologisk avdeling

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: DKD Helios Klinik (Deutsche Klinik für Diagnostik GmbH)

location_facility: Hospital Universitario Clementino Fraga Filho - UFRJ

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie

location_facility: The Ohio State University Wexner Medical Center; Department of Neurology

location_facility: Oklahoma Medical Research Foundation; MS Center of Excellence

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: 401 Military Hospital of Athens; Neurology Department

intervention_type: Other


title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

acronym: STANDUP AHF

summary: A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

ReferenceCitation: Felker GM, McMurray JJV, Cleland JG, O'Connor CM, Teerlink JR, Voors AA, Belohlavek J, Böhm M, Borentain M, Bueno H, Cole RT, DeSouza MM, Ezekowitz JA, Filippatos G, Lang NN, Kessler PD, Martinez FA, Mebazaa A, Metra M, Mosterd A, Pang PS, Ponikowski P, Sato N, Seiffert D, Ye J. Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study. JACC Heart Fail. 2021 Feb;9(2):146-157. doi: 10.1016/j.jchf.2020.10.012. Epub 2020 Nov 25.

ReferenceCitation: Cowart D, Venuti RP, Lynch K, Guptill JT, Noveck RJ, Foo SY. A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS-986231 in Healthy Volunteers. J Clin Pharmacol. 2019 May;59(5):717-730. doi: 10.1002/jcph.1364. Epub 2019 Jan 31.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Spain
Greece
Italy
Netherlands
United Kingdom
Argentina
Canada
United States
France
Japan
Germany
Czechia

location_facility: University of North Carolina at Chapel Hill

location_facility: Wexner Medical Center at The Ohio State University

location_facility: Indiana University Health Methodist Hospital

location_facility: University of Arizona Sarver Heart Center

location_facility: Medical University of South Carolina - PPDS

location_facility: University of Texas Southwestern Medical Center


title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

acronym: EPICOR

summary: The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.

ReferenceCitation: Martín-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.

ReferenceCitation: Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.

ReferenceCitation: Bardají A, Leal M, Arrarte V, Garcia-Moll X, Pérez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.

ReferenceCitation: Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.

ReferenceCitation: Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.

ReferenceCitation: Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.

ReferenceCitation: Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.

ReferenceCitation: Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.

ReferenceCitation: Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.

lead_sponsor: AstraZeneca

location_country:
Denmark
Poland
Brazil
Luxembourg
Romania
Greece
Italy
Mexico
Netherlands
Finland
Argentina
Slovenia
Spain
United Kingdom
Venezuela
France
Turkey
Belgium
Norway
Germany


ipd_sharing: Undecided

status: Terminated

title: A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease

lead_sponsor: Eisai Co., Ltd.

ReferenceCitation: Bullich S, Mueller A, De Santi S, Koglin N, Krause S, Kaplow J, Kanekiyo M, Roé-Vellvé N, Perrotin A, Jovalekic A, Scott D, Gee M, Stephens A, Irizarry M. Evaluation of tau deposition using (18)F-PI-2620 PET in MCI and early AD subjects-a MissionAD tau sub-study. Alzheimers Res Ther. 2022 Jul 27;14(1):105. doi: 10.1186/s13195-022-01048-x.

location_country:
Poland
Portugal
Spain
Greece
Austria
Australia
Russian Federation
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
Japan
Germany
Bulgaria
Slovakia
Czechia

location_facility:
Facility #8
Facility #2
Eisai Trial Site 3
Eisai Trial site 2
Facility #5
Facility #3
Facility #9
Eisai Trail Site 1
Facility #4
Eisai Trial Site 1
Eisai Trial site 5
Facility #11
Facility #7
Eisai Trial Site 2
Eisai Trial Site 4
Facility #10
Facility #1
Facility #6

summary: The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.

status_simplified: Unknown


title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg, 25 mg) Administered Orally, Once Daily Over 24 Weeks in Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control Despite Treatment With Metformin Alone or Metformin in Combination With a Sulfonylurea

lead_sponsor: Boehringer Ingelheim

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: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

ReferenceCitation: Häring HU, Merker L, Seewaldt-Becker E, Weimer M, Meinicke T, Woerle HJ, Broedl UC; EMPA-REG METSU Trial Investigators. Empagliflozin as add-on to metformin plus sulfonylurea in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2013 Nov;36(11):3396-404. doi: 10.2337/dc12-2673. Epub 2013 Aug 20.

location_country:
Taiwan
Slovenia
Canada
Korea, Republic of
United States
France
China
India
Mexico
Turkey
Germany
Slovakia

location_facility: 1245.23.49004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20026 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10159 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86052 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86054 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91103 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20036 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20033 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10158 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86051 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20039 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10143 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86041 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86035 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20028 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20040 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88013 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86013 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86048 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20027 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10133 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20024 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20034 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91102 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10074 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10120 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86032 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10123 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10106 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20029 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33016 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33019 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10046 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74004 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82012 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90007 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20035 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20037 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88021 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10145 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86039 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86040 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86053 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20025 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86055 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86037 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86058 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86056 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33014 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33020 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86043 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10157 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20030 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86045 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10095 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90006 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10127 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20022 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86049 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91104 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10031 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33045 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10153 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33015 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91101 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.88009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10148 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33013 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86057 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.82011 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.49009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10149 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86038 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10042 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33018 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86042 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.91105 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.90001 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.86033 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10109 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.74002 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20038 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10080 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.20032 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10117 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.23.10156 Boehringer Ingelheim Investigational Site

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of two doses of BI 10773 compared to placebo given for 24 weeks as add-on therapy to metformin or metformin plus sulfonylurea in patients with Typ 2 Diabetes Mellitus with insufficient glycaemic control.