title: A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

acronym: BE RADIANT

summary: This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO).

ReferenceCitation: Strober B, Paul C, Blauvelt A, Thaci D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez NN, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023 Sep;89(3):486-495. doi: 10.1016/j.jaad.2023.04.063. Epub 2023 May 12.

oa_host_type: publisher

evidence: open (via crossref license)

ReferenceCitation: Gottlieb AB, Warren RB, Augustin M, Garcia L, Cioffi C, Peterson L, Pelligra C, Ciaravino V. Psychometric Validation of the Psoriasis Symptoms and Impacts Measure (P-SIM): A Novel Patient-Reported Outcome Instrument for Patients with Plaque Psoriasis, Using Reported Data from the BE RADIANT Phase 3b Trial. Adv Ther. 2021 Oct;38(10):5253-5269. doi: 10.1007/s12325-021-01836-1. Epub 2021 Sep 2.

ReferenceCitation: Yeremenko N. Out of the shadow of interleukin-17A: the role of interleukin-17F and other interleukin-17 family cytokines in spondyloarthritis. Curr Opin Rheumatol. 2021 Jul 1;33(4):333-340. doi: 10.1097/BOR.0000000000000805.

ReferenceCitation: Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152. doi: 10.1056/NEJMoa2102383. Epub 2021 Apr 23.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available

lead_sponsor: UCB Biopharma SRL

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


title: A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8 week treatment in patients with essential hypertension

source: euctr

lead_sponsor: NOVARTIS PHARMA SERVICES AG

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

lead_sponsor: Abbott GmbH & Co. KG


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients with Familial Hypercholesterolemia and Inadequately Controlled Low-Density-Lipoprotein Cholesterol

acronym: FOCUS FH

lead_sponsor: Genzyme Corporation and its Affiliates


title: Effects of ivabradine on plaque burden, morphology and composition in patients with clinically indicated coronary angiography. A randomised double-blind placebo-controlled international multicentre study.

acronym: MODIFY

lead_sponsor: Institut de Recherches Internationales Servier


title: A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group, active Controlled Clinical Trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus Glycopyrronium bromide administered via pMDI (CHF 5993) versus indacaterol/glycopyrronium (Ultibro®) via DPI in patients with Chronic Obstructive Pulmonary Disease

acronym: TRIBUTE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP).

acronym: RAISE

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: A Randomized, Open-Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Lumiliximab in Combination with Fludarabine, Cyclophosphamide, and Rituximab Versus Fludarabine, Cyclophosphamide, and Rituximab Alone in Subjects with Relapsed Chronic Lymphocytic Leukemia

acronym: Lumiliximab in combination with FCR in the treatment of relapsed CLL

lead_sponsor: Biogen Idec Ltd


title: A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

lead_sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA


title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination with Topical Treatment (Calcipotriol/Betamethasone) in Subjects with Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

acronym: BELIEVE


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Pfizer

summary: The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

ReferenceType: derived

ReferenceCitation: Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Navarro-Compan V, Wei JC, Van den Bosch F, Magrey M, Wang L, Fleishaker D, Cappelleri JC, Wang C, Wu J, Dina O, Fallon L, Strand V. Effect of tofacitinib on pain, fatigue, health-related quality of life and work productivity in patients with active ankylosing spondylitis: results from a phase III, randomised, double-blind, placebo-controlled trial. RMD Open. 2022 Jun;8(2):e002253. doi: 10.1136/rmdopen-2022-002253.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

publisher_dissemination: British Medical Journal

ReferenceCitation: Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: Leiden University - Leiden Repository

unpaywall_oa_status: hybrid

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi, Ic Hastaliklari

location_facility: Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, rheumatology department,

location_facility: Multiprofile Hospital for active treatment "Kaspela" EOOD

location_facility: Malopolskie Badania Kliniczne Sp. z o.o. s.k.

location_facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Marmara Univ. Istanbul Pendik Egitim ve Arastirma Hastanesi

location_facility: NZOZ JAMED Pracownia Rentgenowska Jerema Antoszewski

location_facility: Pest megyei Flór Ferenc Kórház, Reumatológia-és Fizioterápiás Osztály

location_facility: Rheumatology and Immunology Department, Shanghai Changzheng Hospital

location_facility: Szpital Uniwersytecki w Krakowie, Zaklad Radiologii

location_facility: Paramount Medical Research and Consulting, LLC

location_facility: Zespol Poradni Specjalistycznych REUMED, Wallenroda Filia nr 1

location_facility: Ternopil University Hospital, Department of Rheumatology,

location_facility: VITAL MEDICAL CENTER (VITÁL-MEDICINA Kft.)

location_facility: Limited Liability Company Medical Center "Rheuma-Med"

location_facility: The First Affiliated Hosptial of Wenzhou Medical University

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology

location_facility: State Healthcare Institution "Regional Clinical Hospital"

location_facility: Center for Rheumatology and Bone Research

location_facility: Rheumatology Research Unit Sunshine Coast

location_facility: Geo Medical Sp. z.o.o Szpital Geo Medical

location_facility: Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Trinity Universal Research Associates, Inc.

location_facility: University of California, San Francisco Medical Center

location_facility: Izmir Katip Celebi Univ Ataturk Egitim ve Arastirma Hastanesi

location_facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"

location_facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

location_facility: Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi

location_facility: Military-Medical Clinical Center (Clinical Hospital with 200 beds) of State Border Guard Service of

location_facility: Izmir Katip Celebi Univ. Ataturk Egitim ve Arastirma Hastanesi

location_facility: Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Kyiv City Clinical Hospital # 3, Rheumatology Department

location_facility: Diagnostic-Consulting Center XVII - Sofia

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: RSBHI "Smolensk Regional Clinical Hospital"

location_facility: The Third Affiliated Hospital, Sun Yat-Sen University

location_facility: Lviv Communal Clinical Hospital #4, Rheumatology department

location_facility: Szpital Sw. Elzbiety, Mokotowskie Centrum Medyczne, Zaklad Diagnostyki

title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

enrollment_type: Actual

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.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Poland
Hungary
Israel
Australia
United States
China
Korea, Republic of
Turkey
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France

ipd_sharing: Yes


title: A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients with Metastatic Melanoma

lead_sponsor: Eli Lilly and Company


lead_sponsor: Novartis Pharmaceuticals

summary: The main purpose of this study was to assess the antitumor activity of three combinations: i) LAG525 + spartalizumab; ii) LAG525 + spartalizumab + carboplatin, and iii) LAG525 + carboplatin in participants with advanced triple-negative breast cancer (TNBC) in first or second line therapy.

location_facility:
Novartis Investigative Site
Highlands Oncology Group
Ironwood Cancer and Research Centers

title: A Phase II Open-label, Randomized, Three-arm, Multicenter Study of LAG525 Given in Combination With Spartalizumab (PDR001), or With Spartalizumab and Carboplatin, or With Carboplatin, as First or Second Line Therapy in Patients With Advanced Triple-negative Breast Cancer

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Italy
Hungary
Argentina
Israel
Australia
Japan
Singapore
Lebanon
Belgium
United States
Korea, Republic of
Spain
Thailand
Taiwan
Canada
France


title:
Apixaban for Prevention of Acute Ischemic Events - 2
 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome

acronym: APPRAISE - 2

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Long-term Assessment of Safety and Physical Function with AMG 108 Subcutaneous Monthly Treatment in Subjects with Rheumatoid Arthritis

lead_sponsor: Amgen Inc.


title:
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery.
 + Revised Protocol 01: Incorporates Amendment 02  dated 18-Apr-2007

acronym: The ADVANCE - 2 Study

lead_sponsor: Bristol Myers Squibb International Corporation


acronym: CREAD OLE

lead_sponsor: Hoffmann-La Roche

summary: In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.

location_facility: National Clinical Research Inc.-Richmond

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

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

location_facility: Alzheimer's Research and Treatment Center

location_facility: Neurodegenerative Disorders Research; Neurology

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: SHI City Psychoneurological Dispensary #7 (with Hospital)

location_facility: Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Southern Illinois University, School of Medicine

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Research Center for Clinical Studies, Inc.

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Advanced Memory Research Institute of NJ

location_facility: Institute for Neurodegenerative Disorders

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

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

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

status: Terminated

title: A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease

location_country:
Finland
Germany
Italy
Lithuania
Poland
United Kingdom
Hong Kong
Australia
Mexico
United States
Korea, Republic of
Spain
Turkey
Canada
Russian Federation
France

status_simplified: Unknown


title: A Twenty Eight –Week, Open-Label, Safety Study of Flibanserin 50 milligrams to 100 milligrams dailyin Premenopausal European Women With Hypoactive Sexual Desire Disorder

acronym: Magnolia

lead_sponsor: Boehringer Ingelheim France


title: An Open-Label, Randomized Study To Evaluate The Radiographic Efficacy And Safety Of Enbrel™ (Etanercept) Added To Methotrexate In Comparison With Usual Treatment In Subjects With Moderate Rheumatoid Arthritis Disease Activity.

acronym: Extra

lead_sponsor: Wyeth Pharmaceuticals France


title: A Three-Month, Multicenter, Double-Masked Study Comparing the Safety and Efficacy of the Fixed Combination Travoprost + Brinzolamide Eye Drops, Suspension vs Travatan vs Azopt in Patients with Open-Angle Glaucoma or ocular Hypertension

acronym: Travoprost / Brinzolamide Fixed Combination vs. TRAVATAN and vs. AZOPT

lead_sponsor: Alcon Research, Ltd.


title: Pyruvate Kinase Deficiency Global Longitudinal Registry

acronym: PEAK Registry

summary:
This study is an observational (ie, noninterventional), longitudinal, multicenter, global registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic hemolytic anemia.

This Registry will be open for enrollment for 7 years and all enrolled participants will be followed prospectively for a minimum of 2 years, and up to 9 years.

Data will be collected from participating Registry Physicians, participants, and, where appropriate, parents/guardians who have provided informed consent or assent (where relevant) and authorization pursuant to applicable laws and regulations.

Data should include demographic, clinical, and treatment data; and other data of relevance to the management of patients with PK deficiency. Annual chart review and data entry are expected in order to enhance longitudinal understanding of PK deficiency; however, no specific protocol schedule of assessment is required by this Registry protocol.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Denmark
Netherlands
Switzerland
United States
Korea, Republic of
Spain
Thailand
Turkey
Czechia
Canada
France

location_facility: AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Evangelisches Krankenhaus Bielefeld gGmbH

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitario Germans Trias i Pujol

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

location_facility: Centro Hospitalar Lisboa Central- Hospital Dona Estefania

location_facility: Hospital Universitario Vall d'Hebron - PPDS

status_simplified: Ongoing


title: Effects of a 10 or 15 mg single intravenous bolus of ivabradine versus placebo on heart rate control during a multislice computed tomography coronary angiography for the evaluation of coronary artery disease. A randomised, double blind, international, multicenter study.

lead_sponsor: Institut de Recherches Internationales Servier (I.R.I.S)


summary: The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.

ReferenceCitation: Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

title: A Phase 2,Multicenter,Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab,With or Without Hydroxyurea/Hydroxycarbamide,in Sequential,Descending Age Groups of Pediatric Sickle Cell Disease Patients With Vaso-Occlusive Crisis

location_country:
Germany
Italy
Colombia
India
United Kingdom
Brazil
Switzerland
Lebanon
Belgium
United States
Spain
Turkey
Oman
Canada
France


title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF SUNITINIB PLUS PREDNISONE VERSUS PREDNISONE IN PATIENTS WITH PROGRESSIVE METASTATIC HORMONE-REFRACTORY PROSTATE CANCER AFTER FAILURE OF A DOCETAXEL-BASED CHEMOTHERAPY REGIMEN

lead_sponsor: Pfizer Inc


title: A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy.

lead_sponsor: Amgen Inc


title: A 48-WEEK, DOUBLE BLIND, RANDOMIZED, MULTINATIONAL, MULTICENTRE, 2-ARM PARALLEL GROUP, REFERENCE TREATMENT CONTROLLED CLINICAL TRIAL OF “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA pMDI (CHF 1535 FOSTER®) VERSUS FORMOTEROL IN PATIENTS WITH SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE

lead_sponsor: Chiesi Farmaceutici S.p.A.


title: A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension

acronym: SERAPHIN

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: A Randomized, Double-blind, Placebo-controlled Trial of Long-term (2-year) Treatment of Galantamine in Mild to Moderately-severe Alzheimer’s Disease

lead_sponsor: Janssen Cilag International NV


title: Randomized, Double-blind, Placebo-controlled, Two-Part, Adaptive Design Study of Safety, Tolerability, Preliminary Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of MYK-491 in Patients With Stable Heart Failure With Reduced Ejection Fraction

summary: The purpose of this Phase 1b/2a study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MYK-491 in patients with stable heart failure.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
United Kingdom
Sweden
Netherlands
United States
France

location_facility: University of Pennsylvania Heart and Vascular Center

location_facility: Wojewodzki Szpital Specjalistyczny Im M Kopernika

location_facility: Jacksonville Center for Clinical Research

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu, Oddzial Kardiologiczny z Pododdzialem Intensywnego Nadzoru Kardiologicznego i Pododdzialem Leczenia Zaburzen Rytmu Serca


title: A Randomized Trial of Temsirolimus and Sorafenib as Second-Line Therapy in Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc. Global Medical Affairs


title: A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP

summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.

design_allocation: Non-Randomized

ReferenceCitation: Konteatis Z, Travins J, Gross S, Marjon K, Barnett A, Mandley E, Nicolay B, Nagaraja R, Chen Y, Sun Y, Liu Z, Yu J, Ye Z, Jiang F, Wei W, Fang C, Gao Y, Kalev P, Hyer ML, DeLaBarre B, Jin L, Padyana AK, Dang L, Murtie J, Biller SA, Sui Z, Marks KM. Discovery of AG-270, a First-in-Class Oral MAT2A Inhibitor for the Treatment of Tumors with Homozygous MTAP Deletion. J Med Chem. 2021 Apr 22;64(8):4430-4449. doi: 10.1021/acs.jmedchem.0c01895. Epub 2021 Apr 8.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: U.S. Department of Energy Office of Scientific and Technical Information - OSTI OAI

repository_normalized: US Office of Scientific and Technical Information

version: submittedVersion

publisher_dissemination: American Chemical Society

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
Spain
France

location_facility:
Massachusetts General Hospital
Memorial Sloan Kettering Cance Center
Hospital Universitario Vall d'Hebron
Dana Farber Cancer Institute
Beth Israel
Yale University
Institut Gustave Roussy
Sarah Cannon Cancer Center


title: A MULTICENTER, THREE ARM, RANDOMIZED, OPEN LABEL  CLINICAL STUDY TO COMPARE RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT A MONOCLONAL ANTI-IL2R ANTIBODY (BASILIXIMAB)

acronym: Short Title: DIAMOND Study

lead_sponsor: Astellas Pharma Europe Ltd.


title: A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pre-treatment At the Time of Diagnosis in Patients with Non-ST-Elevation Myocardial Infarction (NSTEMI)  -  The ACCOAST Study

acronym: TADF

lead_sponsor: Eli Lilly


title: Open, randomized, multinational phase IIIb trial evaluating the activity and safety of cetuximab as 250 mg/m² weekly and 500 mg/m² every two weeks maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment for subjects with advanced non-small cell lung cancer (NSCLC)

acronym: NEXT

lead_sponsor: Merck KGaA


acronym:
Phase 2 Study of PT2977 for Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

 Etude de Phase 2 du PT2977 pour le traitement  du cancer du rein associé à la maladie de VHL

lead_sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

summary: This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.

ReferenceCitation: Jonasch E, Donskov F, Iliopoulos O, Rathmell WK, Narayan VK, Maughan BL, Oudard S, Else T, Maranchie JK, Welsh SJ, Thamake S, Park EK, Perini RF, Linehan WM, Srinivasan R; MK-6482-004 Investigators. Belzutifan for Renal Cell Carcinoma in von Hippel-Lindau Disease. N Engl J Med. 2021 Nov 25;385(22):2036-2046. doi: 10.1056/NEJMoa2103425.

oa_colors: green other

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

version: acceptedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

location_facility: National Institutes of Health Clinical Center

location_facility: University of Pennsylvania Medical Center

status: Active, not recruiting

title: An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

location_country:
United States
Denmark
United Kingdom
France


type: Other Grant/Funding Number

title: Biology of Juvenile Myoclonic Epilepsy

acronym: BIOJUME

summary: The investigators are collecting genetic information through blood samples as well as clinical and EEG data from over 1000 people with Juvenile Myoclonic Epilepsy (JME) across the UK, Europe and North America. This study will draw on both existing and new samples from JME patients. These will be compared to anonymised data from samples for 2000 controls. The goal of this study is to find the genetic cause of JME. Finding the cause will help create better treatments for JME, as well as improve patient outcomes by allowing us to detect it earlier.

time_perspective: Other

lead_sponsor: King's College London

sponsor_collaborators:
King's College London
King's College Hospital NHS Trust
Charles University, Czech Republic
Hopital Universitaire Robert-Debre
Vestre Viken Hospital Trust
The Hospital for Sick Children
Cardiff University
Odense University Hospital

location_country:
Italy
Norway
United Kingdom
Denmark
United States
Czechia
Canada
Estonia
France

location_facility: Commissione Genetica Lega Italiana contro l'Epilepssia

location_facility: Walton Centre for Neurology and Neurosurgery

intervention_type: Other


lead_sponsor: Novartis Pharmaceuticals

summary: Efficacy and safety of LNP023 in IgAN patients

title: An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

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:
Finland
Germany
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Czechia
France
Colombia
Hong Kong
Denmark
India
Belgium
China
Malaysia
Norway
Singapore
United Kingdom
Sweden
Netherlands
Korea, Republic of
Taiwan
Israel


title: A Pivotal Phase 2 Trial of Antibody Naxitamab (hu3F8) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow

summary:
Children and adults diagnosed with high-risk neuroblastoma patients with primary refractory disease or incomplete response to salvage treatment in bone and/or bone marrow will be treated for up to 101 weeks with naxitamab and granulocyte-macrophage colony stimulating factor (GM-CSF). Patients will be followed for up to five years after first dose.

Naxitamab, also known as hu3F8 is a humanised monoclonal antibody targeting GD2

lead_sponsor: Y-mAbs Therapeutics

location_country:
Germany
Italy
United Kingdom
Hong Kong
Denmark
United States
Spain
Canada
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: Hospital Infantil Universitario Niño Jesús

intervention_type: Biological


title: An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects with Myelodysplastic Syndromes (MOS)


title: Natural History of the Progression of Choroideremia Study

acronym: NIGHT

summary: The objective of this natural history study is to gain a better understanding of the progression of choroideremia (CHM) and add to the knowledge base for this rare disease.

ReferenceType: background

ReferenceCitation: Hariri AH, Velaga SB, Girach A, Ip MS, Le PV, Lam BL, Fischer MD, Sankila EM, Pennesi ME, Holz FG, MacLaren RE, Birch DG, Hoyng CB, MacDonald IM, Black GC, Tsang SH, Bressler NM, Larsen M, Gorin MB, Webster AR, Sadda SR; Natural History of the Progression of Choroideremia (NIGHT) Study Group. Measurement and Reproducibility of Preserved Ellipsoid Zone Area and Preserved Retinal Pigment Epithelium Area in Eyes With Choroideremia. Am J Ophthalmol. 2017 Jul;179:110-117. doi: 10.1016/j.ajo.2017.05.002. Epub 2017 May 10.

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

lead_sponsor: NightstaRx Ltd, a Biogen Company

location_country:
Finland
Germany
United Kingdom
Denmark
Brazil
Netherlands
United States
Canada
France


title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Centocor BV


title: A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors

summary: The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).

lead_sponsor: Eli Lilly and Company

location_country:
Italy
Denmark
Belgium
United States
Spain
France

location_facility: Hospital Clinico Universitario Virgen de la Victoria


title: A Twenty-Four Week, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in premenopausal European Women With Hypoactive Sexual Desire Disorder

acronym: "Orchid"

lead_sponsor: Boehringer Ingelheim France


title: A multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.

lead_sponsor: Sanofi-Aventis Recherche & Développement


title: A Multinational, Randomized, Double-Blind Study Comparing Aflibercept Versus Placebo in Patients Treated with Second-Line Docetaxel after Failure of One Platinum Based Therapy for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)

acronym: VITAL

lead_sponsor: sanofi-aventis recherche & développement


title: A PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE EFFICACY OF ANIDULAFUNGIN AND VORICONAZOLE IN COMBINATION TO THAT OF VORICONAZOLE ALONE WHEN USED FOR PRIMARY THERAPY OF PROVEN OR PROBABLE INVASIVE ASPERGILLOSIS

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose finding study to evaluate the efficacy, safety, and tolerability of three doses of ACT-128800, an oral S1P1 receptor agonist, administered for twenty-four weeks in patients with relapsing-remitting multiple sclerosis

lead_sponsor: Actelion Pharmaceuticals Ltd


title: A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.

lead_sponsor: F. Hoffmann-La Roche Ltd.


title: A MULTICENTER, SINGLE-ARM, OPEN, CONVERSION STUDY FROM A CYCLOSPORINE (CyA) BASED IMMUNOSUPPRESSIVE REGIMEN TO A TACROLIMUS MODFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN KIDNEY TRANSPLANT SUBJECTS

acronym: CONCERTO

lead_sponsor: Astellas Pharma GmbH


title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DEMONSTRATE THE EFFICACY AND LONG-TERM SAFETY OF DUPILUMAB IN ADULT PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

lead_sponsor: Regeneron Pharmaceuticals, Inc.


title:
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebO (CALISTO).
 An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title: RANDOMIZED, OPEN-LABEL, PHASE 3 TRIAL OF ERLOTINIB ALONE OR IN COMBINATION WITH CP-751,871 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER OF NON-ADENOCARCINOMA HISTOLOGY

lead_sponsor: Pfizer Inc 235 East 42nd Street, New York, NY 10017


title: A randomized,  placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin


title: An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma

summary: This is a multi-center, open-label trial to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib (CA-4948) in adult patients with relapsed or refractory (R/R) hematologic malignancies. Part A will evaluate the safety and tolerability of escalating doses of emavusertib as monotherapy (Part A1), and in combination with ibrutinib. In Protocol Version (v) 1.0 through v6.0, patients with Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma (WM/LPL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) were also enrolled at ibrutinib doses of 420 mg (Part A2). Enrollment into Parts A1 and A2 has been closed. Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in patients with primary central nervous system lymphoma (PCNSL).

lead_sponsor: Curis, Inc.

location_country:
France
Italy
Poland
United States
Spain
Czechia
Israel

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy

location_facility: IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hematology Department Soroka UMC / Heanatology Department

location_facility: Hospital of the University of Pennsylvania

location_facility: Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

location_facility: SODc Ematologia Azienda Ospedaliera Universitaria Careggi

location_facility: UCLA Department of Medicine - Hematology/Oncology


title: A Pan-European, open label, randomised study comparing the efficacy and cost-effectiveness of Symbicort Maintenance and Reliever Therapy (Symbicort SMART) using a maintenance dose of Symbicort 160/4.5 micrograms of 1 or 2 inhalations twice daily in the treatment of persistent asthma. EUROSMART

acronym: EUROSMART

lead_sponsor: AstraZeneca AB


title: Multi center, double blind, randomized, placebo controlled, active reference, parallel group polysomnography study to assess the efficacy and safety of a 16 day oral administration of ACT 078573 in adult subjects with chronic primary insomnia.


title: A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients


title:
Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilate for the treatment and secondary prevention of venous thromboembolism.

 Etude de sécurité en ouvert et non contrôlée, de l’administration intraveineuse d’une dose unique d’idarucizumab à des patients pédiatriques participant aux essais cliniques de phase IIb/III avec le dabigatran étexilate pour le traitement et la prévention secondaire de la maladie thromboembolique


title: A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping.

acronym: CONSCIOUS 2

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2

summary: This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.

lead_sponsor: Neurotech Pharmaceuticals

location_country:
United States
United Kingdom
Australia
France

location_facility: Oxford Eye Hospital, Oxford University Hospitals NHS Foundation Trust

location_facility: Jules Stein Eye Institute / David Geffen School of Medicine

location_facility: Scripps Clinic Carmel Valley Ambulatory Surgery Center

location_facility: Retina Consultants of Southern Colorado, P.C.

location_facility: University of Utah John A. Moran Eye Center

intervention_type: Procedure


title: A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Noncarriers and Participated in Study 3133K1-3000-WW

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development


title: A randomized, double-blind, parallel group, placebo controlled, multi center dose ranging study of solifenacin succinate (3 mg, 6 mg and 9 mg) in combination with tamsulosin OCAS 0.4 mg compared with solifenacin succinate monotherapy (3 mg, 6 mg and 9 mg) and tamsulosin OCAS 0.4 mg monotherapy in males with lower urinary tract symptoms (LUTS) associated with begnin prostatic hyperplasia (BPH) -  [SATURN]

acronym: SATURN

lead_sponsor: Astellas Pharma Europe B.V.


title: A 52-WEEK MULTICENTER, OPEN-LABEL, RANDOMIZED, PARALLEL, TWO - ARM STUDY COMPARING EXUBERA® (INHALED HUMAN INSULIN) VS. HUMALOG® (INSULIN LISPRO), BOTH IN COMBINATION WITH INSULIN GLARGINE IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS - PROTOCOL A2171035.

lead_sponsor: Pfizer Inc


title: OPEN-LABEL, NON-COMPARATIVE, STUDY OF INTRAVENOUS ANIDULAFUNGIN, FOLLOWED OPTIONALLY BY ORAL VORICONAZOLE OR FLUCONAZOLE THERAPY, FOR TREATMENT OF DOCUMENTED CANDIDEMIA/INVASIVE CANDIDIASIS IN INTENSIVE CARE UNIT PATIENT POPULATIONS

lead_sponsor: Pfizer Ltd


title: Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

lead_sponsor: F. Hoffmann-La Roche Ltd


title: Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease

acronym: TIDE

lead_sponsor: GlaxoSmithKline

status: Prematurely Ended


title: A randomized, double-blind, controlled phase III study of Stimuvax® (L-BLP25 or BLP25 liposome vaccine) in combination with hormonal treatment versus hormonal treatment alone for first-line therapy of post-menopausal women with estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive, inoperable locally advanced, recurrent, or metastatic breast cancer STRIDE - STimulating immune Response In aDvanced brEast cancer

acronym: STRIDE

lead_sponsor: Merck KGaA


type: Registry Identifier

title: REFINE: Regorafenib Observational Study in Hepatocellular Carcinoma

summary: Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Argentina
Japan
Thailand
Turkey
Canada
France
Denmark
United States
Belgium
China
Egypt
Italy
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: C.R.Wood Cancer Center, Glen Falls Hospital

location_facility: University of Louisville - Clinical Trials Unit

location_facility: Corporal Michael J. Crescenz VA Medical Center

location_facility: St. Joseph´s Hospital and Medical Center


title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer


title: A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects with Nonvalvular Atrial Fibrillation

acronym: ARISTOTLE

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

lead_sponsor: Celgene Corporation


title: A RANDOMIZED, PHASE 3 STUDY OF SUNITINIB IN COMBINATION WITH CAPECITABINE COMPARED WITH CAPECITABINE IN PATIENTS WITH PREVIOUSLY TREATED BREAST CANCER

lead_sponsor: Pfizer Inc.


title: Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients

lead_sponsor: Merck Serono S.A. - Geneva


title: A Randomized Trial Comparing two therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects with Type 2 Diabetes who were previously treated by basal insulin Glargine with either Metformin or Metformin and Sulfonylurea

acronym: GWDM or Etude 4B

lead_sponsor: Eli Lilly and Company Limited


title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-033, an Anti-LAG-3 Monoclonal Antibody, Alone and in Combination With an Anti-PD-1 in Patients With Advanced Solid Tumors

acronym: CITRINO

summary: This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-lymphocyte activation gene-3 (LAG-3) antibody TSR-033 alone, in combination with the anti-PD-1 antibody dostarlimab, and in combination with dostarlimab, modified folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) (mFOLFOX6) or FOL/leucovorin, 5-fluorouracil and irinotecan (IRI) (FOLFIRI), and bevacizumab in participants with advanced solid tumors in a broad range of solid tumors. Participants with disease types selected for evaluation in this study are expected to derive clinical benefit with addition of an anti-PD-1. The study will be conducted in two parts with Part 1 consisting of dose escalation to determine the recommended phase 2 dose (RP2D) of TSR-033 as a single agent (Part 1a) and in combination with dostarlimab (Part 1c). RP2D decisions will be based on the occurrence of dose-limiting toxicities (DLTs), pharmacokinetics (PK), as well as pharmacodynamics (PDy) data. Part 2A of the study will investigate the anti-tumor activity of TSR-033 and dostarlimab in combination in participants with advanced or metastatic microsatellite stable colorectal cancer (MSS-CRC). Part 2B of the study will investigate the safety and anti-tumor activity of TSR-033 and dostarlimab in combination with chemotherapy (Cohort B1: mFOLFOX6 and Cohort B2: FOLFIRI) and bevacizumab in participants with advanced or metastatic MSS-CRC.

ipd_sharing: No

lead_sponsor: Tesaro, Inc.

sponsor_collaborators:
Tesaro, Inc.
GlaxoSmithKline

location_country:
United States
France


title: A Randomised, Double-blind, Parallel Group, Phase 3, Efficacy and Safety Study of AZD6140 Compared with Clopidogrel for Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary Syndromes (ACS) [PLATO – A Study of PLATelet inhibition and Patient Outcomes.]

acronym: PLATO

lead_sponsor: AstraZeneca AB


title: Efficacy and safety assessment of T4032 (unpreserved bimatoprost 0.01%) versus Lumigan® 0.01% in ocular hypertensive or glaucomatous patients.

acronym: In-SIGHT study

lead_sponsor: Laboratoires THEA


title: A Phase III, Observer-Blind, Randomized, Non-influenza Vaccine Comparator-Controlled, Parallel-Group, Multi-Country Study in Children Aged 6-35 Months to Assess the Safety and Efficacy of Abbott’s Candidate Quadrivalent Influenza Vaccine.

lead_sponsor: Abbott Biologicals B.V.

status: Not Authorised


title: A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by endovascular coiling.

acronym: CONSCIOUS 3

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: A multi-center, randomized, double-blind, placebo-controlled phase III trial comparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL)

acronym: MAIN


title: Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice

summary: The study addresses the safety, utilisation and effectiveness of Obizur in the treatment of bleeding episodes in real-life clinical practice in Europe and the United States.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

collaborators: Baxalta Innovations GmbH, now part of Shire

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
United States
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: The University of Texas Health Science Center at Houston

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden


title:
A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer
 patients

lead_sponsor: TESARO Inc.


title: EuroNet-Paediatric Hodgkin's Lymphoma Group / First International inter-group study for classical Hodgkin’s lymphoma in children and adolescents

acronym: EURONET PHL C1

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

lead_sponsor_type: academique


title: A Long-term Access Programme for Subjects with Severe Asthma who Participated in a GSK-sponsored Mepolizumab Clinical Study

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Randomized Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

lead_sponsor: Amgen Inc


title: Clinical and Basic Investigations Into Phosphomannomutase Deficiency (PMM2-CDG)

summary:
Clinical and Basic Investigations into Phosphomannomutase deficiency (PMM2-CDG)

This is a natural history (observational) protocol designed to collect clinical and biological information in patients with PMM2-CDG (CDG-Ia).

ReferenceCitation: Cechova A, Honzik T, Edmondson AC, Ficicioglu C, Serrano M, Barone R, De Lonlay P, Schiff M, Witters P, Lam C, Patterson M, Janssen MCH, Correia J, Quelhas D, Sykut-Cegielska J, Plotkin H, Morava E, Sarafoglou K. Should patients with Phosphomannomutase 2-CDG (PMM2-CDG) be screened for adrenal insufficiency? Mol Genet Metab. 2021 Aug;133(4):397-399. doi: 10.1016/j.ymgme.2021.06.003. Epub 2021 Jun 11.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: Radboud University - Radboud Repository

repositories:
LIRIAS (KU Leuven)
PubMed Central
repository.ubn.ru.nl

repositories_concat: LIRIAS (KU Leuven);PubMed Central;repository.ubn.ru.nl

repositories_institution:
KU Leuven - Lirias
Radboud University - Radboud Repository

lead_sponsor: Glycomine, Inc.

location_country:
Italy
Poland
Portugal
Netherlands
Belgium
United States
Spain
Czechia
France

location_facility: Mother and Child Institute (Instytut Matki i Dziecka)

location_facility: Radboud University Nejmegen Medical Center

location_facility: Children's Hospital of Philadelphia (CHOP)


title:
A randomized, double blind, placebo controlled multicenter dose ranging study to assess the safety and efficacy of multiple oral ZPL389 doses in patients with moderate to severe Atopic Dermatitis (ZEST trial)

 Etude dose-réponse, multicentrique, randomisée, en double aveugle, contrôlée par placebo, évaluant la tolérance et l’efficacité de doses multiples de ZPL389 par voie orale chez des patients atteints de dermatite atopique modérée à sévère (étude ZEST)

acronym: A study to assess the safety and efficacy of ZPL389 doses in patients with moderate to severe AD

lead_sponsor: Novartis Pharma AG


title: Micra Atrial Tracking Using a Ventricular Accelerometer Study

acronym: MARVEL

summary:
The purpose of this study is to characterize performance of the MARVEL algorithm downloaded into the MicraTM TPS to provide atrial synchronous ventricular pacing in subjects with AV block.

A sub-study will be conducted within the Marvel study, the purpose of this study is to characterize the MARVEL algorithm in patients who were enrolled in the MARVEL study, and to collect and compare the accelerometer signals and AV synchrony at a second point in time.

primary_purpose: Device Feasibility

ReferenceCitation: Chinitz L, Ritter P, Khelae SK, Iacopino S, Garweg C, Grazia-Bongiorni M, Neuzil P, Johansen JB, Mont L, Gonzalez E, Sagi V, Duray GZ, Clementy N, Sheldon T, Splett V, Stromberg K, Wood N, Steinwender C. Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies. Heart Rhythm. 2018 Sep;15(9):1363-1371. doi: 10.1016/j.hrthm.2018.05.004. Epub 2018 May 11.

repositories_concat: LIRIAS (KU Leuven)

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Denmark
Austria
Belgium
United States
Spain
Malaysia
Czechia
France

location_facility: Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello

location_facility: Kepler Universitätsklinikum Med Campus III

location_facility: Hospital Universitari Clínic de Barcelona

intervention_type: Device


title:
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized-withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis

 Étude de phase 3 d’une durée de 46 semaines, en double aveugle, avec une période de retrait randomisée de 6 semaines contrôlée par placebo évaluant la sécurité d'emploi et l'efficacité de la relamoreline chez des patients atteints de gastroparésie diabétique.

acronym:
Diabetic Gastroparesis Study with Randomized-withdrawal Period

 Étude de la gastroparésie diabétique avec une période d'arrêt randomisée

lead_sponsor: Allergan Ltd.


title: Phase 3, Single-arm, Open-label, Multidose, Titration, Pharmacokinetic, Pharmacodynamic, and Safety Study of Etelcalcetide in Children and Adolescents ? 2 to < 18 Years of age With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Maintenance Hemodialysis.

lead_sponsor: Amgen Inc.

status: Ongoing


title: Paediatric Hepatic International Tumour Trial

acronym: PHITT

lead_sponsor: University of Birmingham


title: Rate of Progression in USH2A-related Retinal Degeneration

summary: The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with USH2A related retinal degeneration associated with congenital hearing loss (Usher syndrome type 2a) or non-syndromic retinitis pigmentosa (RP39).

ipd_sharing_description: A de-identified database is available upon request through the public domain on the FFB/Jaeb public website.

lead_sponsor: Jaeb Center for Health Research

sponsor_collaborators:
Jaeb Center for Health Research
Foundation Fighting Blindness

location_country:
Germany
United Kingdom
Netherlands
United States
Canada
France

location_facility: Kellogg Eye Center, University of Michigan

location_facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild Functional Mitral Regurgitation

summary: The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).

ReferenceCitation: Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

ReferenceCitation: Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

ReferenceCitation: Lipiecki J, Siminiak T, Sievert H, Muller-Ehmsen J, Degen H, Wu JC, Schandrin C, Kalmucki P, Hofmann I, Reuter D, Goldberg SL, Haude M. Coronary sinus-based percutaneous annuloplasty as treatment for functional mitral regurgitation: the TITAN II trial. Open Heart. 2016 Jul 8;3(2):e000411. doi: 10.1136/openhrt-2016-000411. eCollection 2016.

lead_sponsor: Cardiac Dimensions, Inc.

location_country:
United States
Greece
France

location_facility: Vassar Brothers- Hudson Valley Cardiovascular Practice

location_facility: Dignity Health Research Institute at Mercy Gilbert and Chandler Regional Medical Centers

location_facility: Lindner Research Center at the Christ Hospital


title: A Phase 1/2, Open-Label, Multicenter Study to Investigate the Safety and Preliminary Efficacy of Combined Bempegaldesleukin (NKTR-214) and Pembrolizumab With or Without Chemotherapy in Patients With Locally Advanced or Metastatic Solid Tumors

acronym: PROPEL

summary:
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy.

The study is comprised of two groups; dose optimization and dose expansion cohorts.

Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC)

The dose expansion cohort will include first-line NSCLC patients.

lead_sponsor: Nektar Therapeutics

location_country:
Germany
Australia
United States
Spain
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Washington University School of Medicine in St. Louis

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Sarah Cannon Research Institute (SCRI) (The SCRI Oncology Research Consortium)

location_facility: Augusta University - Augusta University Medical Center

location_facility: New York University Langone Medical Center

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: Park Nicollet - Frauenshuh Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Highlands Oncology Group, PA - North Hills

location_facility: Hospital Universitari i Politècnic La Fe


title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor

acronym: ESCAPE-TRD

lead_sponsor: Janssen-Cilag International NV


title: European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial

acronym: EU-SolidAct

lead_sponsor: Oslo University Hospital


title:
A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY,
 ACTIVE CONTROLLED MULTI-CENTER STUDY ASSESSING THE EFFICACY AND SAFETY OF ABROCITINIB COMPARED WITH DUPILUMAB IN ADULT PARTICIPANTS ON BACKGROUND TOPICAL THERAPY WITH MODERATE TO SEVERE ATOPIC DERMATITIS

 ÉTUDE MULTICENTRIQUE DE PHASE 3B, RANDOMISÉE, EN DOUBLE AVEUGLE, À DOUBLE PLACEBO, AVEC TRAITEMENT DE RÉFÉRENCE, VISANT À ÉVALUER L’EFFICACITÉ ET LA SÉCURITÉ D’EMPLOI DE L’ABROCITINIB COMPARÉ AU DUPILUMAB CHEZ DES PARTICIPANTS ADULTES ATTEINTS DE DERMATITE ATOPIQUE MODÉRÉE À SÉVÈRE RECEVANT UN TRAITEMENT TOPIQUE DE FOND

lead_sponsor: Pfizer Inc.


lead_sponsor: Genfit

summary: The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

ReferenceCitation: Schattenberg JM, Pares A, Kowdley KV, Heneghan MA, Caldwell S, Pratt D, Bonder A, Hirschfield GM, Levy C, Vierling J, Jones D, Tailleux A, Staels B, Megnien S, Hanf R, Magrez D, Birman P, Luketic V. A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA. J Hepatol. 2021 Jun;74(6):1344-1354. doi: 10.1016/j.jhep.2021.01.013. Epub 2021 Jan 21.

location_facility: The Newcastle Upon Tyne Hosptials NHS Foundation Trust

location_facility: University of Birmingham Centre for Liver Research

location_facility: Clinic for Gastroenterology and Hepatology

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid

location_country:
Germany
United Kingdom
United States
Spain
France


title:
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

 Étude de phase III randomisée, contre placebo, en double aveugle comparant des gélules d'acide nor-ursodésoxycholique au placebo dans le traitement de la cholangite sclérosante primitive

lead_sponsor: Dr. Falk Pharma GmbH


title: A Multi-national Phase IIIb, Double-blind, Placebo-controlled Trial to Determine the Safety and Efficacy of STALORAL® Birch 300 IR in Children and Adolescents 5 to 17 Years old with Birch Pollen-induced Allergic Rhinoconjunctivitis with or without Asthma

acronym: YOBI

lead_sponsor: STALLERGENES


title:
European Network of Paediatric Hodgkin Lymphoma Second International Inter-Group Study for Classical Hodgkin Lymphoma in Children and Adolescents (EuroNet-PHL-C2)

 EuroNet-PHL-C2.  Seconde Etude Internationale de l’inter-groupe des Lymphomes de Hodgkin Classiques de l’Enfant, de l’Adolescent et de l’Adulte jeune (EuroNet-PHL-C2)

lead_sponsor: JUSTUS LIEBIG UNIVERSITY OF GIESSEN


title: Multi-center, Randomized, Double-blind, Parallel-group, Double-dummy, Active-controlled, Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ponesimod Versus Fingolimod During 108 Weeks of Treatment in Pediatric Participants, 10 to <18 Years Old, with Relapsing-remitting Multiple Sclerosis

acronym: PIONEER


title: A phase III randomized, double-blind study of induction(daunorubicin/cytarabine) and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML)

lead_sponsor: Novartis Pharma Services AG


title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF POMALIDOMIDE, BORTEZOMIB AND LOW-DOSE DEXAMETHASONE VERSUS BORTEZOMIB AND LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

lead_sponsor: Celgene Corporation


title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

lead_sponsor: Rigel Pharmaceuticals, Inc.


title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced  Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

acronym: Pembrolizumab+FP/XP vs. Placebo+FP/XP in Biomarker Select,  Advanced Gastric  or GEJ Adenocarcinoma

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,


title: A randomised, double-blind, placebo-controlled, multicentre, Phase 3 study evaluating long-term efficacy and safety of lanifibranor in adult patients with non-cirrhotic non-alcoholic steatohepatitis (NASH) and fibrosis 2 (F2)/fibrosis 3 (F3) stage of liver fibrosis

lead_sponsor: Inventiva S.A.


title:
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E MUTANT COLORECTAL CANCER

 ÉTUDE OUVERTE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE DE LA COMBINAISON ENCORAFÉNIB ET CÉTUXIMAB COMME TRAITEMENT DE
 PREMIÈRE INTENTION, AVEC OU SANS CHIMIOTHÉRAPIE, COMPARÉE AU TRAITEMENT STANDARD, AVEC UNE PHASE PRELIMINAIRE DE SECURITE POUR L’ASSOCIATION AVEC LA CHIMIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER COLORECTAL MÉTASTATIQUE AVEC
 MUTATION BRAF V600E

acronym: The BREAKWATER Study


title:
IntReALL HR 2010
 International Study for Treatment of High Risk Childhood Relapsed ALL 2010

lead_sponsor: Charité - Universitätsmedizin Berlin


title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 - A randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

acronym: IntReALL SR 2010

lead_sponsor: Charité - University Hospital of Berlin


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease has Remained Stable or Responded to First-Line Platinum-Based Chemotherapy with Pembrolizumab forStage IIIB or IV Non-Small Cell Lung Cancer

lead_sponsor: GlaxoSmithKline Research & Development Ltd.


title:
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)

 Elacestrant en monothérapie contre traitement standard du cancer du sein métastatique RO+ HER2- après traitement préalable par inhibiteur de CDK4/6: une étude de phase 3, randomisée, ouverte, contrôlée et multicentrique (EMERALD)

acronym: EMERALD

lead_sponsor: Radius Pharmaceuticals Inc.


title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients with HRD-Positive Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

 Étude de phase 3, randomisée, en double aveugle, contrôlée contre placebo, multicentrique, évaluant le traitement d'entretien par niraparib chez des patientes atteintes d’un cancer de l'ovaire avancé avec défaut de recombinaison homologue (HRD-positif) en réponse à une chimiothérapie de première ligne à base de platine

lead_sponsor: TESARO, Inc.


title: A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency

lead_sponsor: Novo Nordisk A/S


title: A PHASE III, RANDOMIZED, OPEN-LABEL STUDY OF PRALSETINIB VERSUS STANDARD OF CARE FOR TREATMENT OF RET-MUTATED MEDULLARY THYROID CANCER

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A phase I/II study of Inotuzumab Ozogamicin as a single agent and in combination with chemotherapy for pediatric CD22-positive relapsed/refractory Acute Lymphoblastic Leukemia

lead_sponsor: Erasmus Medical Center


title:
A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

 Etude de phase III, multicentrique, randomisée, en double aveugle, en groupes parallèles, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi de LNP023 chez des patients atteints de néphropathie primaire à IgA

lead_sponsor: Novartis Pharma AG


title: A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION

acronym: ADVANCE-extension

lead_sponsor: Arena Pharmaceuticals, Inc.


title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

lead_sponsor: Arena Pharmaceuticals Inc.


title: A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

lead_sponsor: BeiGene, Ltd.


title: Phase 1 Study of Lorlatinib (PF-06463922), an Oral Small Molecule Inhibitor of ALK/ROS1, for Patients With ALK-Driven Relapsed or Refractory Neuroblastoma

summary: Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).

ReferenceCitation: Baranowska-Kortylewicz J, Kortylewicz ZP, McIntyre EM, Sharp JG, Coulter DW. Multifarious Functions of Butyrylcholinesterase in Neuroblastoma: Impact of BCHE Deletion on the Neuroblastoma Growth In Vitro and In Vivo. J Pediatr Hematol Oncol. 2022 Aug 1;44(6):293-304. doi: 10.1097/MPH.0000000000002285. Epub 2021 Sep 6.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: New Approaches to Neuroblastoma Therapy Consortium

collaborators: Children's Neuroblastoma Cancer Foundation

collaborators: The Catherine Elizabeth Blair Memorial Foundation

location_country:
United States
United Kingdom
Canada
France

location_facility: Children's Hospital and Regional Medical Center - Seattle

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: University of Chicago, Comer Children's Hospital

location_facility: Childrens Hospital Boston, Dana-Farber Cancer Institute.


title:
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
 (CheckMate 7FL: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 7FL)

acronym: Nivo/Placebo with Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in ER+/HER2-Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title:
A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

 Étude randomisée menée en ouvert comparant le ponatinib au nilotinib chez des patients atteints de leucémie myéloïde chronique en phase chronique suite à une résistance à l'imatinib

acronym: OPTIC 2L

lead_sponsor: ARIAD Pharmaceuticals, Inc.


title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia Coronavirus COVID-19 (REMAP-CAP-COVID-19)

acronym: REMAP-CAP

lead_sponsor: University Medical Center Utrecht


title:
A 52-week, randomised, double-blind, double-dummy, parallel group,multi-centre, non-inferiority study assessing exacerbation rate,
 additional measures  of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 compared with mepolizumab or benralizumab

 Étude de 52 semaines de non-infériorité, randomisée, en double aveugle, avec double placebo, en groupes parallèles, multicentrique, évaluant le taux d’exacerbation, le contrôle de l’asthme et la sécurité d’emploi chez des patients adultes et adolescents atteints d’asthme sévère présentant un phénotype éosinophilique et traités par GSK3511294, par rapport au traitement par mépolizumab ou benralizumab

lead_sponsor: GlaxoSmithKline Research & Development Limited


title:
High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)
 Randomized, international and multicentric phase 3 study that evaluates and compares 2 treatment strategies in 3 therapeutic phases (induction, high-dose chemotherapy and radiotherapy) for patients with high-risk neuroblastoma.

 Etude internationale multicentrique de phase 3 randomisée qui évalue et compare 2 stratégies de traitement dans 3 phases thérapeutiques (induction, chimiothérapie à haute dose et radiothérapie) pour les patients atteints de neuroblastome de haut-risque.

lead_sponsor: Gustave Roussy


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects with Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed after Prior VEGFR-Targeted Therapy

lead_sponsor: Exelixis, Inc.


title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis

acronym: HARBOR

lead_sponsor: Blueprint Medicines Corporation


title:
A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary
 Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid

lead_sponsor: Intercept Pharmaceuticals, Inc.


title:
I6T-MC-AMAP
 A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-
 Term Efficacy and Safety of Mirikizumab in Patients with Moderately to
 Severely Active Ulcerative Colitis (LUCENT 3)

 I6T-MC-AMAP
 Étude d’extension de Phase 3, multicentrique, en ouvert visant à évaluer la sécurité et l’efficacité à long terme du mirikizumab chez les patients atteints de rectocolite hémorragique active modérée à sévère (LUCENT 3)

acronym: LUCENT 3

lead_sponsor: Eli Lilly and Company


title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

lead_sponsor: Amgen Inc


title:
A Phase 3 Study Comparing Daratumumab, VELCADE (bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Previously Untreated Multiple Myeloma who are Eligible for High-dose Therapy

 Étude de phase 3 comparant l’association de daratumumab, VELCADE (bortézomib), lénalidomide et dexaméthasone (D-VRd) par rapport au traitement par VELCADE (bortézomib), lénalidomide et dexaméthasone (VRd) chez des patients présentant un myélome multiple non traités auparavant mais éligibles à un traitement à fortes doses

acronym:
The Perseus trial

 Etude Perseus

lead_sponsor: European Myeloma Network (EMN)


acronym: DIVERGENCE 1

lead_sponsor: Gilead Sciences

summary: The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) < 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

ReferenceCitation: Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.

sponsor_collaborators:
Gilead Sciences
Galapagos NV

location_facility: Royal Devon and Exeter Hospital, Department of Gastroenterology

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza

location_facility: Fargo Gastroenterology and Hepatology Clinic

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Center for lnterventional Endoscopy- Florida Hospital

location_facility: Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1

location_facility: Hospital Universitario Gran Canaria Dr. Negrin

location_facility: Bugát Pál Kórház, Gasztroenterológiai osztály

location_facility: Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology

location_facility: CHU de Toulouse -Hopital Rangueil (Main Office)

location_facility: University of South Florida South Tampa campus

location_facility: Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology

location_facility: Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma

location_facility: Indiana University Health University Hospital

location_facility: Medical University of Innsbruck, Department of Internal Medicine I

location_facility: Azienda Ospedaliero - Universitaria Mater Domini

location_facility: Gastroenterologie, Hepatologie und Endokrinologie

location_facility: Gastroenterology Research of San Antonio

location_facility: Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University

title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

location_country:
Germany
Italy
Hungary
United Kingdom
Austria
Belgium
United States
Spain
Czechia
Canada
Ukraine
France


title: Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia

lead_sponsor: Milestone Pharmaceuticals Inc.


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

lead_sponsor: Galderma S.A.


title:
A Randomised Double-Blind Placebo-Controlled Phase III Clinical  Study to Evaluate the Efficacy and Safety of Cobitolimod as an Induction and Maintenance Therapy in Participants with Moderate  to Severe Active Left-Sided Ulcerative Colitis

 Étude clinique de phase 3, randomisée, en double aveugle, contrôlée par placebo visant à évaluer l’efficacité et l’innocuité du cobitolimod en traitement d’induction et d’entretien chez des participants présentant une rectocolite hémorragique affectant la partie gauche du côlon modérément à sévèrement active

acronym: CONCLUDE

lead_sponsor: InDex Pharmaceuticals


title: A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease

lead_sponsor: Incyte Corporation


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors

lead_sponsor: Novo Nordisk A/S


title: A Randomized, Double-Blind, Dose Finding and Comparison Study of the Safety and Efficacy of a High Dose of Eteplirsen, Preceded by an Open-label Dose Escalation, in Patients with Duchenne Muscular Dystrophy With Deletion Mutations Amenable to Exon 51 Skipping

lead_sponsor: Sarepta Therapeutics, Inc.


title: A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

acronym: Ph 3 Trial of MK-3475 (Pembrolizumab) vs Standard Treatment in Recurrent/Metastatic Head and Neck Ca

lead_sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.


title: A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

lead_sponsor: IVERIC bio, Inc.


title:
A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021

 Etude randomisée, à 3 bras de traitement, en double aveugle, de non-infériorité, d’une durée de 2 ans, comparant l’efficacité et la sécurité d’emploi de l’ofatumumab et du siponimod versus fingolimod chez des patients pédiatriques atteints de sclérose en plaques, suivie d’une extension en ouvert.

acronym: NEOS

lead_sponsor: Novartis Pharma AG


title: A Randomized, Controlled, Open-Label, Phase 3 Study of Melflufen/ Dexamethasone Compared with Pomalidomide/Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide

lead_sponsor: Oncopeptides AB


title: Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache

lead_sponsor: H. Lundbeck A/S


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects with Moderately to Severely Active Ulcerative Colitis

lead_sponsor: Amgen Inc.


title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors


title: Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults

acronym: DisCoVeRy

lead_sponsor: INSERM


title: A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin

acronym: SWITCH

lead_sponsor: Merck Sharp & Dohme Corp.


title: A 52-week open-label extension study of the long-term safety and efficacy of rosiglitazone extended-release (RSG XR) as adjunctive therapy to acetylcholinesterase inhibitors in subjects with mild-to-moderate Alzheimer's disease (REFLECT-4).

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

summary: The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
Poland
Portugal
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
Estonia
France

location_facility: Main Line Health Center/Lankenau Hospital

location_facility: Saint John Regional Hospital - New Brunswick Heart Centre

location_facility: CHI St. Luke's Health Baylor College of Medicine

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: Centralny Szpital Kliniczny MSW w Warszawie


title: A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of mongersen (GED-0301) for the treatment of adult and adolescent subjects with active Crohn’s disease

acronym: A Study of Efficacy and Safety of GED-0301 in Adults and Adolescents with Crohn's Disease

lead_sponsor: Celgene Corporation


lead_sponsor: Shire

summary: The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

location_facility: Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

location_facility: Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC

location_facility: Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH

location_facility: University of Waterloo School of Optometry and Vision Science

location_facility: Advanced Laser Vision & Surgical Institute

location_facility: The Ottawa Hospital - General Campus, University of Ottawa Eye Institute

location_facility: Emanuelli Research & Development Center, LLC

location_facility: University of the Sunshine Coast Clinical Trials Centre

location_facility: East Tallinn Central Hospital Eye Clinic

location_facility: DCT- Shah Research, LLC dba Discovery Clinical Trials

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS

location_facility: Vienna Institute for Research in Ocular Surgery

location_facility: Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus)

location_facility: Cornea and Cataract Consultants of Arizona

location_facility: Centro Dotal de Investigaciones de Servicios de Salud

title: A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis

location_country:
Italy
Poland
Hungary
Israel
Australia
Austria
United States
Spain
South Africa
Canada
Estonia
Puerto Rico
France


title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Who are Medically Managed - The TRILOGY ACS Study

acronym: Trilogy ACS

lead_sponsor: Eli Lilly and Company


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis

lead_sponsor: Millennium Pharmaceuticals, Inc.


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail

lead_sponsor: Amgen Inc


title: An Open, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus


title:
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY

 — OPEN-LABEL ESL EXTENSION —

acronym: not applicable

lead_sponsor: BIAL - Portela & Ca, S.A.


title: A Pan-European randomized, parallel group, two-arm placebo-controlled, double-blind multicenter study of Rimonabant 20mg once daily in the treatment of abdominally obese patients with impaired fasting blood glucose with or without other comorbidities

lead_sponsor: sanofi aventis groupe


title: Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma

summary:
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)

This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.

lead_sponsor: Polyganics BV

location_country:
Germany
Italy
United Kingdom
Sweden
United States
Spain
France

location_facility: Veterans affairs Medical Center Portland

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: University Hospital Lund - Department of Hand Surgery

location_facility: The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)

location_facility: Stanford Medical Center Hand and Upper Limb Center

location_facility: Virginia Commonwealth University Medical Center


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome

lead_sponsor: Takeda Global Research & Development Centre (Europe) Ltd.


title:
A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with
 MK-5172 in a Prior Clinical Trial


title: Randomized, multinational, double-blind study, comparing a high loading dose regimen of clopidogrel versus standard dose in patients with unstable angina or non-ST segment elevation myocardial infarction managed with an early invasive strategy

acronym: CURRENT

lead_sponsor: sanofi-aventis recherche et développement


title: A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of MLN0002 in Patients with Ulcerative Colitis and Crohn’s Disease


title: A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis

lead_sponsor: Novartis Pharma Services AG


title:
A phase 3  multi-center, long-term extension study investigating the efficacy and safety of  PF-04965842, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis

 Étude d’extension à long terme, multicentrique, de phase III, évaluant l’efficacité et la tolérance du PF-04965842, avec ou sans médicaments topiques, administrés à des sujets âgés de 12 ans et plus, atteints de dermatites atopiques modérées à graves

lead_sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017


title: A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE)

lead_sponsor: Novo Nordisk A/S


title:
A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)

 Etude multicentrique randomisée, en double aveugle, contrôlée par placebo, évaluant l’effet de l'inclisiran sur les événements cardiovasculaires majeurs chez des patients atteints d'une maladie cardiovasculaire établie (VICTORION-2 PREVENT)

acronym: Study of inclisiran to prevent cardiovascular (CV) events in participants with established cardiovas

lead_sponsor: Novartis Pharma AG


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

acronym: ELEVATE UC OLE

lead_sponsor: Arena Pharmaceuticals Inc.


title:
An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis

 Etude d’extension, multicentrique, en ouvert, à un seul bras évaluant la sécurité d’emploi, la tolérance et l’efficacité à long-terme de l’ofatumumab chez des patients atteints de sclérose en plaques récurrente.


title: A PHASE 4 RANDOMIZED CLINICAL TRIAL OF ANDEXANET ALFA [ANDEXANET ALFA FOR INJECTION] IN ACUTE INTRACRANIAL HEMORRHAGE IN PATIENTS RECEIVING AN ORAL FACTOR XA INHIBITOR

lead_sponsor: Portola Pharmaceuticals, Inc


title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease


title: Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study.

acronym: SIGNIFY

lead_sponsor: Institut de Recherches Internationales Servier