title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

acronym: Celestial 47

lead_sponsor: Cephalon, Inc.


title: An open-label trial with TMC125 as part of an ART including TMC114/rtv and an investigator-selected OBR in HIV-1 infected subjects who participated in a DUET trial (TMC125-C206 or TMC125-C216).

source: euctr

lead_sponsor: Tibotec Pharmaceuticals Limited

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-naïve HIV-1 infected subjects

acronym: Thrive


title: A Phase IIa, Double-blind, Randomised, Parallel-group, Multi-centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2423 Compared to Placebo in Patients with Posttraumatic Neuralgia

lead_sponsor: AstraZeneca AB


title: A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY REGIMENS IN SUBJECTS WITH PREVIOUSLY TREATED METASTATIC BREAST CANCER

lead_sponsor: Genentech Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study, to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sulphonylurea Therapy

acronym: CANTATA-MSU Trial

lead_sponsor: Janssen-Cilag International NV


title: A randomized, open-label phase II study evaluating the efficacy and safety of FOLFOX-4 plus cetuximab versus UFOX plus cetuximab as first-line therapy in subjects with metastatic colorectal cancer

acronym: FUTURE

lead_sponsor: Merck KGaA


title: A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

lead_sponsor: Amgen Inc


title: A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer


title: The Safety and Efficacy of AL-8309B Ophthalmic Solution for the Treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

acronym: Geographic Atrophy Treatment Evaluation (GATE)

lead_sponsor: Alcon Research, Ltd


title: A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination with AMG 386 or Placebo in Subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

lead_sponsor: Amgen Inc.


title: A Phase III Open-Label, Single-Group Extension Study to Obtain Long-Term Safety and Tolerability Data of Idebenone in the Treatment of Friedreich's Ataxia Patients

acronym: MICONOS EXTENSION

lead_sponsor: Santhera Pharmaceuticals (Switzerland) Ltd


title: The Impact of LY2189265 versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)

acronym: GBDC

lead_sponsor: Eli Lilly & Company - Indianapolis


title: A Phase 3 Randomized, Double-Blind Trial of Pembrolizumab (MK-3475) in Combination with Epacadostat (INCB024360) or Placebo in Participants with Cisplatin-ineligible Urothelial Carcinoma (KEYNOTE-672/ECHO-307)

acronym: Phase 3 Study of Pembro with/without Epacadostat in 1L Urothelial Carcinoma

lead_sponsor: Incyte Corporation


title:
Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to
 Evaluate the Efficacy and Safety of Terguride Plus Symptomatic Therapy
 in Subjects With Diffuse Cutaneous Systemic Sclerosis

acronym: TERGISS

lead_sponsor: medac GmbH

status: Prematurely Ended

status_simplified: Unknown


title: A multinational, randomized, double-blind placebo controlled study of AVE8062 (25 mg/m²) administered every 3 weeks in patients with advanced-stage soft tissue sarcoma, treated with cisplatin (75 mg/m²) after failure of anthracycline and ifosfamide chemotherapies.

lead_sponsor: sanofi-aventis recherche et développement


title: An Open-Label, Multicenter Study of the Effects of Remission Maintenance Therapy with Ceplene® (Histamine Dihydrochloride), Given in Conjunction with Low-Dose Interleukin-2 (IL-2, Proleukin), on Immune Response and Minimal Residual Disease (MRD) in Adult Patients with Acute Myeloid Leukemia (AML) in First Complete Remission (CR1)

lead_sponsor: EpiCept Corporation


title: A Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy


title: Study FDC114615: Comparative efficacy of DuodartTM plus lifestyle advice versus watchful waiting plus lifestyle advice with step-up therapy to tamsulosin in the management of treatment naïve men with moderately symptomatic benign prostatic hyperplasia and prostate enlargement.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


title: Efficacy and safety of the SQ tree SLIT-tablet in subjects with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch group

lead_sponsor: ALK Abello A/S


title: A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA

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


title: A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer


title: Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia

lead_sponsor: H. Lundbeck A/S


title: A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symptoms

acronym: FIELD (Fabrazyme: Intervening Early at a Lower Dose)

lead_sponsor: Genzyme Europe BV


title: A PHASE 2B/3 OPEN-LABEL ROLLOVER STUDY FOR SUBJECTS DISCONTINUING FROM THE UK-453,061 PROTOCOLS FOR THE TREATMENT OF HIV-1 INFECTED SUBJECTS


title: A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.

lead_sponsor: F Hoffmann-La Roche Ltd


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Using Cinacalcet to Correct Hypercalcemia in Renal Transplant Recipients With Autonomous Hyperparathyroidism.


title: A PHASE 2B MULTICENTER, RANDOMIZED, COMPARATIVE TRIAL OF UK-453,061 VERSUS ETRAVIRINE IN COMBINATION WITH DARUNAVIR/RITONAVIR AND A NUCLEOTIDE/NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED HIV-1 INFECTED SUBJECTS WITH EVIDENCE OF NNRTI RESISTANT HIV-1

lead_sponsor: Pfizer Inc


title: A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection

lead_sponsor: F.Hoffmann-La Roche


title:
A Randomized, Double-Blind, Multi-Center Phase 2 Trial of Exemestane (Aromasin®) plus Dasatinib versus Exemestane plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer after Disease Progression on a Non-steroidal Aromatase Inhibitor (NSAI).
 + Administrative Letter 1 dated 18-Aug-2008.

lead_sponsor: Bristol Myers Squibb International Corporation


title: A Phase 2a/2b study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects with Genotypes 1 and 4 Chronic Hepatitis C Infection.

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor

acronym: Study comparing the Efficacy and Safety of Retosiban Versus Atosiban in Spontaneous Preterm labor

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A phase II randomised, double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin in patients with moderate hepatic impairment (Child-Pugh B) with genotype 1b chronic hepatitis C infection

lead_sponsor: Boehringer Ingelheim France


title: Cilengitide in subjects with newly diagnosed glioblastoma multiforme and unmethylated MGMT gene promoter - a multicenter, open-label Phase II study, investigating two cilengitide regimens in combination with standard treatment (temozolomide with concomitant radiation therapy, followed by temozolomide maintenance therapy) - CORE.

acronym: CORE

lead_sponsor: Merck KGaA


title: ICON7 - A randomised, two-arm, multicentre Gynaecologic Cancer InterGroup trial of adding bevacizumab to standard chemotherapy (carboplatin and paclitaxel) in patients with epithelial ovarian cancer.

acronym: ICON7 GCIG Trial (International Collaborative Ovarian Neoplasm 7)

lead_sponsor: Medical Research Council


title: A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled trial of Ustekinumab, a Fully Human anti-IL-12/23p40 Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Psoriatic Arthritis and Previously Treated with Biologic Anti-TNFα Agent(s)

lead_sponsor: Centocor B.V.


title: A PHASE 2, RANDOMIZED, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND ANTI-CYTOMEGALOVIRUS (CMV) ACTIVITY OF MARIBAVIR VERSUS VALGANCICLOVIR FOR TREATMENT OF CMV INFECTIONS IN TRANSPLANT RECIPIENTS WHO DO NOT HAVE CMV ORGAN DISEASE

lead_sponsor: VIROPHARMA INCORPORATED


title: A Multicenter, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-Term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1-to-11-Year-Old Pediatric Subjects with Endoscopically Proven GERD

lead_sponsor: Janssen-Cilag International NV


title: Effect of Olmesartan Medoxomil on Arterial Stiffness and Thickness in Subjects with Metabolic Syndrome

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


title: Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a “Standard Chemotherapy Regimen”

acronym: Chemotherapy Adjuvant Study for women at advanced Age (CASA)

lead_sponsor: International Breast Cancer Study Group (IBCSG)


title: Effect of LY450139, a γ-Secretase Inhibitor, on the Progression of Alzheimer’s Disease as Compared with Placebo

lead_sponsor: Eli Lilly and Company


title: Prospective randomised phase II trial of oral vinorelbine and cisplatin or pemetrexed and cisplatin in first line Metastatic or Locally Advanced Non-Small-Cell Lung Cancer patients with non-squamous histological type.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: A Phase 2, Randomized Study of VELCADE® (bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who are Candidates for Autologous Transplantation.

lead_sponsor: Janssen-Cilag International, N.V.Turnhoutseweg 30, 2340 Beerse, Belgium


title: A Randomised, Multicentre, Open Label, Phase II study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib with Capecitabine for the Treatment of Metastatic Breast Cancer.

lead_sponsor: GlaxoSmithKline research & Development


title: A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of NS-304 in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

lead_sponsor: Nippon Shinyaku Co., Ltd.


title: A randomized, multicentre, open-label, Phase II study of the efficacy and safety of lapatinib plus epirubicin and cyclophosphamide (EC90-L) followed by weekly paclitaxel and lapatinib (PX-L) compared with EC90 followed by weekly paclitaxel and trastuzumab (PX-T), as neoadjuvant therapy in patients with previously untreated ErbB2-overexpressing Stage I - IIIA invasive breast cancer with primary tumour size > 1cm.

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase 2B, randomized, blinded, dose-ranging, active-controlled, parallel-group, multi-center study to evaluate the dose response relationship of GSK1278863 over the first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks in hemodialysis-dependent subjects with anemia associated with chronic kidney disease who switch from recombinant human erythropoietin.


title: A Phase III, randomised, double blind, placebo controlled study to evaluate the safety and efficacy of subcutaneous implants of CUV1647 in patients suffering from polymorphic light eruption (PLE).

acronym: Phase III Trial of CUV1647 in PLE

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: A PROSPECTIVE, MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE WITH MIDAZOLAM FOR CONTINUOUS SEDATION OF VENTILATED PATIENTS IN INTENSIVE CARE UNIT

acronym: Midex

lead_sponsor: Orion Corporation Orion Pharma


title: Open-Label Extension for Alzheimer’s Disease Patients Who Complete One of Two Semagacestat Phase 3 Double-Blind Studies (H6L-MC-LFAN or H6L-MC-LFBC)


title: Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers.

acronym: not available

lead_sponsor: Nerviano Medical Sciences S.r.l.


study_start_date_type: Actual

acronym: CENTAUR

intervention_type: Drug

lead_sponsor: Tobira Therapeutics, Inc.

summary: The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

ReferenceType: derived

ReferenceCitation: Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22. Erratum In: Gastroenterology. 2022 Aug;163(2):536.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

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license_normalized: no license

repository_normalized: PubMed Central

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

version: submittedVersion

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

license: cc-by

license_normalized: cc-by

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: HAL

unpaywall_oa_status: hybrid

ReferenceCitation: Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22. No abstract available.

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Nottingham - Repository@Nottingham

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

ReferenceCitation: Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Columbia University - Columbia Academic Commons

ReferenceCitation: Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

title: CENTAUR: Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Subjects With Liver Fibrosis

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


title:
DORADO-AC - Optimized Doses of Darusentan as Compared to an Active Control in Resistant Hypertension
 A Phase 3 Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-center, Parallel Group Study to Evaluate the Safety and Efficacy of Darusentan in Subjects with Resistant Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine or Placebo

acronym: DORADO-AC

lead_sponsor: Gilead Sciences, Inc.


title: A MULTI-CENTER, LONG TERM, OPEN-LABEL STUDY OF [S,S]-REBOXETINE (PNU-165442G) ADMINISTERED ONCE DAILY IN PATIENTS WITH FIBROMYALGIA

lead_sponsor: Pfizer Inc.,


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Efficacy of a Single Treatment of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Injected into the Prostate for the Treatment of Lower Urinary Tract Symptoms in Patients due to Benign Prostatic Hyperplasia

lead_sponsor: Allergan Inc.


title: A two-arm, randomised, double-blind, placebo-controlled, multicenter phase II study to evaluate safety and tolerability and to explore the neuroprotective effect of atacicept as assessed by Optical Coherence Tomography (OCT) in subjects with Optic Neuritis (ON) as Clinically Isolated Syndrome (CIS) over a 36 week treatment course

acronym: Atacicept in Optic Neuritis, Phase II

lead_sponsor: Merck Serono International S.A.


title: A prospective randomized, open-labelled, multi-centre trial comparing the safety and efficacy of Ritonavir-boosted Aptivus (Tipranavir, TPV/r) to that of Prezista® (Darunavir, DRV/r) in  three-class (NRTI, NNRTI, and PI) treatment-experienced patients with resistance to more than one PI. POTENT: PrOspecTive EvaluatioN of Tipranavir vs. Darunavir in Treatment Experienced Patients

acronym: POTENT

lead_sponsor: Boehringer Ingelheim France SAS


title: A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies

lead_sponsor: H. Lundbeck A/S


title: A Multicenter, Open-Label, Randomized Study Comparing the Efficacy and Safety of  S-1 as a Single Agent at 30 mg/m2 BID versus 5-FU Bolus Infusion for the Treatment of Patients with Metastatic Pancreatic Cancer Previously Treated with a Gemcitabine Based-Regimen

acronym: S-1 Pancreas

lead_sponsor: sanofi-aventis recherche & developpement


title: Efficacy and safety of 2mg/day of M100907 on Sleep Maintenance Insomnia with a sub-study of the effect of M100907 on stable Type II Diabetes Mellitus: a 12-week, multi-center, randomized, double-blind, placebo-controlled study

acronym: SAMS 12 (Sleep And Metabolism Study, 12 weeks)

lead_sponsor: sanofi-aventis recherche & développement


title: A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients who are Ineligible to Receive Cisplatin-Based Therapy

acronym: VINCENT

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A randomized, multicenter, open-label, 6-month study to explore the efficacy and safety of enteric coated mycophenolate sodium (Myfortic) in combination with two corticosteroid regimens for the treatment of lupus nephritis flare

acronym: Mylupus

lead_sponsor: Novartis Pharma Services AG


title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia.

lead_sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium


title:
Prospective Trial for the diagnosis and treatment of
 children, adolescents and young adults with Intracranial Germ Cell Tumours

 essai prospectif pour le diagnostic et le traitement des enfants, adolescents et jeunes adultes porteurs d’une tumeur germinale intracrânienne

acronym: SIOP CNS GCT II

lead_sponsor: Universitätsklinikum Münster

lead_sponsor_type: academique


title: Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety with Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, 26-Week, Multicenter Study With a 26-Week Extension, to Evaluate the Efficacy, Safety and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment

lead_sponsor: Janssen Cilag international NV


title: An open label follow-up trial of the efficacy and safety of chronic administration of the combination of telmisartan 40mg + amlodipine 5mg or the combination of telmisartan 80mg + amlodipine 5mg tablets alone or in combination with other antihypertensive medications in patients with hypertension.


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial With an Open-Label Extension Phase of Perampanel as Adjunctive Treatment in Subjects at Least 2 years of Age With Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome

lead_sponsor: Eisai Limited


title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

lead_sponsor: Incyte Corporation


title:
Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steatohepatitis (NASH).

 Étude multicentrique, en ouvert, évaluant la sécurité et la tolérance de doses croissantes d’HepaStem chez des patients atteints de stéatohépatite non-alcoolique (également appelé NASH) à un stade de cirrhose ou de pré-cirrhose.

lead_sponsor: Promethera Biosciences


title: A multicenter, international, randomised, double-blind, placebo controlled study to demonstrate the clinical efficacy and safety of a subcutaneous immunotherapy with gpASIT+™ in patients with grass pollen-induced allergic rhinoconjunctivitis

acronym: not availabe

lead_sponsor: BioTech Tools S.A.


title:
A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFα, vedolizumab and/or corticosteroids.

 Etude de phase IIa comparant la tolérance et l’efficacité d’ABX464 administré à la dose quotidienne de 50 mg à un placebo chez des sujets présentant une rectocolite hémorragique active modérée à sévère résistants ou intolérants aux traitements immunomodulateurs, aux Anti-TNFα, au vedolizumab et/ou aux corticoïdes.

acronym:
Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.

 Etude de tolérance et d’efficacité de l’ABX464 chez des patients atteints de colite ulcéreuse active

lead_sponsor: ABIVAX


title: A double-blind, randomised, placebo-controlled, multicentre, relapse-prevention study with two doses of Lu AA21004 in patients with Major Depressive Disorder.

acronym: Not applicable


title: A randomised, double-blind, parallel-group, placebo-controlled and active-referenced study evaluating the efficacy and safety of three fixed dose regimens of Lu AA34893 in the treatment of Major Depressive Disorder.


title: A multicenter, randomized, double blind (double dummy), active-comparator controlled study to compare the efficacy, safety and tolerability of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled with sulfonylurea (SU) monotherapy or metformin plus sulfonylurea combination therapy.

acronym: EMERGE 6

lead_sponsor: F. Hoffmann-La Roche Ltd


title: An international, randomised, double blinded, multi-centre, active- and placebo-controlled dose response trial to evaluate the efficacy and safety of SABER-Bupivacaine for postoperative pain control in patients following arthroscopic shoulder surgery

lead_sponsor: Nycomed Danmark ApS


title: A PHASE 3 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, FIRST LINE MAINTENANCE STUDY OF LENALIDOMIDE (REVLIMID®) IN PATIENTS WITH MANTLE-CELL LYMPHOMA

acronym: The RENEW trial

lead_sponsor: Celgene Corporation


title: MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical study A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis

acronym: MUSIC

lead_sponsor: Actelion Pharmaceuticals Ltd.


title: EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN NEUTROPENIC PATIENTSWITH INVASIVE CANDIDA INFECTION

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


title:
A multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO)

 Étude multicentrique, randomisée, en double aveugle, contrôlée contre placebo, en groupes parallèles visant à évaluer l'efficacité, la tolérance et la sécurité d’une perfusion sous-cutanée continue de ND0612 administrée comme traitement complémentaire à la lévodopa orale chez des patients atteints de la maladie de Parkinson avec fluctuations motrices (iNDiGO)

acronym: iNDiGO

lead_sponsor: NeuroDerm Ltd.


title: Phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma

acronym: RTOG

lead_sponsor: EORTC


title:
Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy

 Etude en ouvert, en escalade de dose, visant à évaluer la tolérabilité, la toxicité, la tolérance, la pharmacocinétique, la pharmacodynamie et l’activité du volasertib administré en plus d’une chimiothérapie de rattrapage associant daunorubicine liposomale, fludarabine et cytarabine (DNX-FLA) suivie de l’association fludarabine et cytarabine (FLA) chez des enfants de 3 mois à moins de 18 ans ayant une leucémie myéloïde aiguë après échec d’une chimiothérapie de première ligne.

lead_sponsor: BOEHRINGER INGELHEIM


title: A randomized, double-blind, placebo controlled, multi-centre, phase IIA study to assess the effect on GERD symptoms, pharmacokinetics, safety and tolerability of four weeks treatment with AZD3355 65 mg bid as add-on treatment to a PPI  in patients with an incomplete response to PPI treatment

lead_sponsor: AstraZeneca AB


title: A phase II, multicentre study of oral LBH589 in patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

lead_sponsor: Novartis Pharma Services AG


title: A phase II, multicentre study of oral LBH589 in patients with accelerated phase or blast phase (blast crisis) chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors


title: Open label study of bevacizumab maintenance therapy (AVASTIN) with or without pemetrexed after a first line treatment chemotherapy with bevacizumab-cisplatin-pemetrexed in patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC)


title: A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy


title:
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled
 Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.

acronym: RELAX-AHF

lead_sponsor: Corthera, Inc.


title: A 52-Week, International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 52-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone


title: Randomized, double-blind, placebo and comparator-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in the treatment of excessive daytime sleepiness in narcolepsy

acronym: Harmony I bis

lead_sponsor: Bioprojet


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Global Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once Daily Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.

acronym: A Study in Benign Prostatic Hyperplasia

lead_sponsor: Eli Lilly and Company


title: A multicenter, double-blind, placebo-controlled, randomised, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib in patients with mild to moderate Alzheimer’s disease

lead_sponsor: AB Science

status: Prohibited by CA


title: A multicenter, open-label, randomized, active-controlled, parallel group, pivotal study to investigate the efficacy, safety and tolerability, and pharmacokinetics of murepavadin combined with one anti-pseudomonal antibiotic versus two anti-pseudomonal antibiotics in adult subjects with ventilator-associated bacterial pneumonia suspected or confirmed to be due to Pseudomonas aeruginosa.

lead_sponsor: Polyphor Ltd.


title: A Well-Controlled, Fixed-Dose Study of TEV 50717 (Deutetrabenazine) for the Treatment of Tics Associated with Tourette Syndrome

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.


title: Phase III confirmatory efficacy and safety trial of remimazolam (CNS7056) compared with propofol for intravenous anaesthesia during elective surgery

lead_sponsor: PAION UK Limited


title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

acronym: PiSARRO

lead_sponsor: Aprea AB


title: A phase 2 randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study of the safety and efficacy of I-0401 in the treatment of patients with fractures of the tibial plateau requiring grafting.

lead_sponsor: Kuros Biosurgery AG


title: A randomised, double-blind, placebo-controlled, multi-national Phase II/III study of the safety and efficacy of two doses of sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adult patients suffering from house dust mite allergic rhinitis

lead_sponsor: Stallergenes S.A


title: Cetrorelix pamoate (AEZS-102) in patients with symptomatic BPH: a double-blind placebo-controlled efficacy study

lead_sponsor: Aeterna Zentaris GmbH


title: Efficacy and safety of ASF 1057 cream 0.5% in the treatment of seborrhoeic dermatitis: A phase III randomised, double-blind, vehicle-  and placebo controlled, parallel groups, multi-centre trial.

lead_sponsor: Astion Pharma A/S


title: Efficacy and Safety of AP  12009 in Adult Patients with Recurrent or Refractory Anaplastic Astrocytoma (WHO grade III) as Compared to Standard Treatment with Temozolomide or BCNU: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.

acronym: SAPPHIRE

lead_sponsor: Antisense Pharma GmbH


title: A controlled open label randomised parallel group study to evaluate the efficacy, safety, and tolerability of subcutaneous MIRCERA, versus no ESA therapy, in the treatment of anaemia in CKD patients after kidney transplant.

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A randomised, double-blind, placebo-controlled, multi-national, Phase III trial to assess the efficacy and safety of 300 IR sublingual immunotherapy (SLIT) administered as allergen-based tablets once daily to adolescents and children above the age of 5 years, suffering from house dust mite allergic rhinitis

lead_sponsor: Stallergenes S.A.


title: A Phase I/II Pharmacokinetic Study of Intravenous and Oral Forodesine in Children with Relapsed or Refractory T-cell or B-cell Precursor Acute Lymphoblastic Leukaemia or T-cell Non- Hodgkin’s Lymphoma

lead_sponsor: Mundipharma Research Limited


title:
A PHASE 4, BLOOD SAMPLE COLLECTION STUDY FOR EXPLORATORY EVALUATION OF THE ASSOCIATION OF SINGLE NUCLEOTIDE
 POLYMORPHISMS WITH TREATMENT RESPONSES FROM SUBJECTS WITH HBEANTIGEN POSITIVE OR NEGATIVE CHRONIC HEPATITIS B, WHO RECEIVED THERAPY FOR HEPATITIS B WITH PEGINTERFERON ALFA-2A 40KD (PEG-IFN) ± NUCLEOS(T)IDE ANALOGUE

lead_sponsor: F.Hoffmann-La Roche Ltd.


title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in Combination with Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

acronym: Zalutumumab in Combination with Chemo-Radiation in NSCLC

lead_sponsor: Genmab A/S


title: A Phase 3 Study of Pembrolizumab in Combination with Etoposide/Platinum (Cisplatin or Carboplatin) Followed by Pembrolizumab with or without Maintenance Olaparib in the First-line Treatment of Participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

acronym: Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 1L ES SCLC

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


title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects with Advanced Solid Tumors and Lymphomas

lead_sponsor: Astex Pharmaceuticals, Inc.

status: Ongoing

status_simplified: Ongoing


title:
A Phase II Randomised, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients with Platinum-Sensitive Relapsed Epithelial Ovarian Cancer, who have Previously Received PARP Inhibitor Maintenance Treatment

 Étude de phase II, multicentrique, randomisée, destinée à évaluer l’efficacité et la tolérance d’un deuxième traitement d’entretien chez des patientes présentant un cancer épithélial de l’ovaire en rechute platine-sensible, ayant reçu préalablement un premier traitement d’entretien par inhibiteur de PARP

lead_sponsor: AstraZeneca AB


title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib with Lomustine to the Efficacy of Lomustine Alone

acronym: REGAL

lead_sponsor: ASTRAZENECA


title: A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years with Functional Constipation

lead_sponsor: Sucampo Pharma Europe Ltd.


title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Coadministered with Ribavirin in Adults with Genotype 4 Chronic Hepatitis C Virus  Infection and Cirrhosis

lead_sponsor: AbbVie Deutschland GmbH & Co. KG


title:
A randomized, open-label, Phase 2 study of nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated, metastatic pancreatic adenocarcinoma

 Etude de phase II, randomisée, en ouvert, comparant 2 schémas thérapeutiques de l'irinotécan nanoliposomal (nal-IRI) avec un traitement par nab-paclitaxel et gemcitabine chez des patients présentant un adénocarcinome pancréatique métastatique non précédemment traité

lead_sponsor: Merrimack Pharmaceuticals, Inc.


title:
Randomized controlled trial of S-1 maintenance therapy in metastatic esophagogastric cancer

 Etude contrôlée randomisée évaluant le traitement d’entretien par S-1 dans le cancer oesophagogastrique métastatique

acronym: MATEO (Maintenance Teysuno in esophagogastric carcinoma)

lead_sponsor: AIO-Studien-gGmbH


title: A phase IIb, prospective, multicentre, double-blind, triple-arm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months.

acronym:
ADIPOA 2

 ADIPOA 2

lead_sponsor: CHU Montpellier


title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Patients With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 or Narcolepsy Type 2)

lead_sponsor: Takeda Development Center Americas, Inc.


title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy

lead_sponsor: Incyte Corporation


title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma

lead_sponsor: AVEO Pharmaceuticals, Inc.


title: A PHASE II STUDY EXPLORING THE SAFETY AND EFFICACY OF ATEZOLIZUMAB ADMINISTERED IN COMBINATION WITH OBINUTUZUMAB OR RITUXIMAB ANTI-CD20 THERAPY IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA, MARGINAL ZONE LYMPHOMA AND WALDENSTRÖM MACROGLOBULINEMIA

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A Randomized, Double-blinded, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination with Pegasys® and Copegus® versus the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection.


title: Randomized, Double-Blind, Placebo-Controlled, Three-Arm, 9-Month, Brain Imaging and Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) (LMTM) in Subjects with Early  Alzheimer’s Disease.

lead_sponsor: TauRx Therapeutics Ltd


title: A Randomized Phase 3 Study of the Combination of Pembrolizumab (MK-3475) Plus Epacadostat (INCB024360) Alone or with Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients with Metastatic Non-Small Cell Lung Cancer

acronym: Phase 3 Study of Pembrolizumab/Epacadostat/Chemotherapy in Metastatic NSCLC


title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF CD5024 1% CREAM TREATMENT FOR UP TO 52 WEEKS  IN SUBJECTS  WITH  PAPULOPUSTULAR ROSACEA

lead_sponsor: GALDERMA R&D SNC


title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)

acronym: PATIDEGIB Phase 3 OLE study in subjects with Gorlin syndrome

lead_sponsor: PellePharm, Inc.


title: Randomized, comparative, open label treatment with double-blind placebo-controlled periods within treatment study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to once-a-week prophylaxis treatment and to on-demand treatment with rFVIII-FS reconstituted with water for injection in previously treated patients with severe hemophilia A

lead_sponsor: Bayer Healthcare LLC


title: The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis: A Phase 2 Randomized, double-blind, four–arm, parallel, placebo-controlled and active descriptive-comparator, 40 week trial

lead_sponsor: Peptimmune Inc.


title: Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in children aged from birth to less than 2 years, including preterm neonates.

lead_sponsor: Grünenthal GmbH


title: Multinational européan trial for children with the opsoclonus myoclonus syndrome/dancing eye syndrome.

acronym: OMS

lead_sponsor: INSTITUT CURIE


title:
An open-label, multi-center long-term safety roll-over study in patients with tuberous sclerosis complex (TSC) and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.

 Etude d‘extension (roll-over), multicentrique, en ouvert, évaluant la sécurité d’emploi à long terme d’évérolimus chez les patients atteints de sclérose tubéreuse de Bourneville présentant des crises d’épilepsie pharmacorésistantes et continuant à tirer bénéfice du traitement selon l’investigateur après avoir terminé l'étude CRAD001M2304

lead_sponsor: Novartis Pharma AG


title:
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia

 Etude randomisée de phase III visant à comparer le trioxyde d’arsenic (ATO) combiné à de l’ATRA et de l’Idarubicine contre un traitement standard de l’ATRA et de la polychimiothérapie à base d’antracyclines (schéma AIDA) chez les patients avec une leucémie aiguë promyélocytaire de haut risque nouvellement diagnostiquée – Etude APOLLO

acronym:
APOLLO

 APOLLO

lead_sponsor: Technische Universität Dresden


title: An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)

lead_sponsor: Albireo AB


title: A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study).

lead_sponsor: ABIVAX


title:
BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY

 Brentuximab vedotin associé à la chimiothérapie chez des patients atteints de lymphome de hodgkin stade I/II défavorable au diagnostic.
 Une étude randomisée de phase II de l’intergroupe LYSA-FIL-EORTC.

acronym: BREACH

lead_sponsor: LYSARC


title: Phase III Multicenter Open-Label Randomized Trial to Evaluate Efficacy and Safety of CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone (CHAM) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in Older Patients (≥60 years) with Relapsed/Refractory Acute Myeloid Leukemia (AML)

acronym: ARMADA 2000

lead_sponsor: Rafael Pharmaceuticals, Inc.


title: A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc


title:
A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants with Moderately to Severely Active Ulcerative Colitis

 Étude de phase 3, randomisée, en double aveugle, à bras parallèles, contrôlée par placebo et traitement de référence, portant sur le mirikizumab et le védolizumab chez des participants atteints de rectocolite hémorragique active modérée à sévère

acronym: LUCENT-ACT

lead_sponsor: Eli Lilly and Company


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined with Ruxolitinib in Patients with Primary Myelofibrosis (PMF), Post–Polycythemia Vera MF (Post–PV-MF), Or Post–Essential Thrombocythemia MF (Post-ET-MF) Who Have a Suboptimal Response to Ruxolitinib

lead_sponsor: Kartos Therapeutics, Inc.


title:
Multicenter, Open Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease after Failure of Rituximab or Rituximab and Chemotherapy (ALLELE Study)

 Étude de phase III, ouverte, multicentrique, évaluant le tabélecleucel chez des patients ayant reçu une transplantation d’organe solide ou de cellules souches hématopoïétiques allogéniques, atteints d’une lymphoprolifération post-transplantation liée au virus Epstein-Barr, après échec d'un traitement par rituximab ou rituximab et chimiothérapie (étude ALLELE)

acronym: ALLELE study

lead_sponsor: Atara Biotherapeutics, Inc.


title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)

lead_sponsor: ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE


title:
A Phase III, Double-Blind, Randomized, Placebo-Controlled and Parallel Group Study to Evaluate the Efficacy and Safety of Opicapone, as Add on to Stable Levodopa (L-DOPA) Plus a Dopa Decarboxylase Inhibitor (DDCI) Therapy in Early Idiopathic Parkinson’s Disease Patients, with an Open-Label Extension
 The EPSILON Study: Early Parkinson wIth L-DOPA/DDCI and Opicapone

acronym: EPSILON

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


title:
An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 (Leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/ p110δ-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

 Etude en ouvert, non randomisée, de détermination de la dose intra patient, suivie par une étude randomisée, en aveugle pour les patients, les médecins-investigateurs et Novartis, contrôlée par placebo, évaluant l’efficacité et la sécurité d’emploi de CDZ173 (leniolisib) chez des patients atteints d’APDS/PASLI (Syndrome de PI3K-delta activée/Déficit immunitaire, lymphadénopathie et cellules T sénescentes dus à des mutations activatrices de p110-delta)

acronym: Study of efficacy of CDZ173 in patients with APDS/PASLI

lead_sponsor: Novartis Pharma Services AG


title:
Long Term Extension Trial of setmelanotide (RM-493) for patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

 Essai d'extension à long terme portant sur la setmélanotide (RM-493) chez des patients ayant terminé un essai utilisant la setmélanotide dans le traitement de l'obésité liée à des défauts génétiques en amont du récepteur aux mélanocortines de type 4 (MC4R) dans la voie leptine-mélanocortine

lead_sponsor: Rhythm Pharmaceuticals, Inc.


title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

lead_sponsor: Applied Molecular Transport Inc.


title:
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous Caspofungin Followed by Optional Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis (The ReSTORE Study)

 Étude de phase 3, multicentrique, randomisée, en double aveugle évaluant l'efficacité et la sécurité des injections de Rezafungine par rapport à la Caspofungine administrée en intraveineux avec un relai possible par Fluconazole par voie orale dans le traitement des patients atteints de candidémie et/ou de candidose invasive (étude ReSTORE)

lead_sponsor: Cidara Therapeutics Inc.


title: A Phase 1/2 trial on the safety, tolerability, pharmacokinetics, pharmacodynamics and exploratory efficacy of DYN101 in patients ≥ 16 years of age with centronuclear myopathies caused by mutations in DNM2 or MTM1

acronym: Research Using an Investigational Treatment for CNM (Unite-CNM)

lead_sponsor: Dynacure SAS


title:
PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem

 PROLONGSTEM : Registre sur la sécurité à long terme d’HepaStem Registre pour les patients qui ont été perfusés avec HepaStem

lead_sponsor: Promethera Biosciences


title: A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TRK-750 in Colorectal Cancer Patients with Chemotherapy-induced Peripheral Neuropathy Following Oxaliplatin-containing Chemotherapy in the Adjuvant Setting

lead_sponsor: Toray Industries, Inc.


title: A phase I/II, multicenter, open-label study of EGFRmut–TKI EGF816,administered orally in adult patients with EGFRmut solid malignancies

lead_sponsor: Novartis Pharma AG


title:
A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

 NiCCC (Nintedanib (BIBF1120) en comparaison à une chimiothérapie chez les patients en rechute d’un Carcinome à Cellules Claires de l’ovaire ou de l’endomètre)

acronym:
NiCCC Trial (BIBF1120)

 NICCC

lead_sponsor: Greater Glasgow Health Board


title: A Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

lead_sponsor: Apellis Pharmaceuticals, Inc.


title:
A Phase 1/2, Open-label, Multicenter, Non-randomized Study to  Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Pediatric Patients from Birth to Less than 1 Year of Age with X-linked Hypophosphatemia (XLH)

 Étude de phase 1/2, en ouvert, multicentrique, non randomisée visant à évaluer la sécurité d’emploi, la tolérance, la  pharmacocinétique et l’efficacité  du burosumab chez des patients pédiatriques depuis la naissance jusqu’à l’âge d’un an et atteints d’hypophosphatémie  liée à l’X (XLH)

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd.


title:
A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing surgery or delivery

 Étude prospective de phase 3, multicentrique, en ouvert, non contrôlée, visant à évaluer l’efficacité, la sécurité d’emploi et la pharmacocinétique d’Atenativ chez des patients atteints d’un déficit congénital en antithrombine nécessitant une intervention chirurgicale ou un accouchement

lead_sponsor: Octapharma AG


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination with Acalabrutinib in Subjects with Relapsed/Refractory Diffuse Large B-cell Lymphoma or Relapsed/Refractory Chronic Lymphocytic Leukemia

lead_sponsor: Kartos Therapeutics Inc.


title:
A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia

 Étude de phase III, randomisée, en double aveugle, destinée à évaluer l'efficacité de l'Uproleselan administré en association avec la chimiothérapie versus la chimiothérapie seule chez des patients atteints de leucémie myéloïde aiguë récidivante/réfractaire.

lead_sponsor: GlycoMimetics, Inc.


title: PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF)

acronym: PRESTIGE-AF

lead_sponsor: Imperial College of Science, Technology and Medicine


title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN 144) for Treatment of Patients with Metastatic Melanoma

acronym: Study of LN-144 in the Treatment of Patients with Metastatic Melanoma

lead_sponsor: Iovance Biotherapeutics, Inc.


title: A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)

lead_sponsor: Mirati Therapeutics, Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Taldefgrobep Alfa in Ambulatory and Non-Ambulatory Participants with Spinal Muscular Atrophy with Open-Label Extension (RESILIENT)

acronym: RESILIENT

lead_sponsor: Biohaven Pharmaceuticals, Inc.


title:
Phase IIb, Placebo-Controlled, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Allogeneic Osteoblastic Cells (ALLOB) Single Implantation in Tibial Fracture

 Étude de phase IIb, contrôlée par placebo, randomisée, en double aveugle, multicentrique, visant à évaluer l’efficacité et la sécurité d’emploi d’une implantation unique de cellules ostéoblastiques allogéniques (ALLOB®) dans la fracture du tibia

lead_sponsor: Bone Therapeutics S.A.


title:
A randomized, treatment open-label, dose-blinded, parallel group, three arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.

 Etude clinique de preuve de concept randomisée, à 3 groupes parallèles, avec traitement en ouvert et posologies en aveugle, visant à étudier l'efficacité et la sécurité d’emploi du LNP023 par rapport au rituximab dans le traitement des patients atteints de glomérulonéphrite extra-membraneuse idiopathique.


title: A Phase 2, single-arm, pathologist-blinded study using liver biopsy specimens to assess copper concentration and histopathologic changes in patients with Wilson disease who are treated with ALXN1840 for 48 weeks followed by an extension treatment period with ALXN1840 for up to an additional 48 weeks

lead_sponsor: Alexion Pharmaceuticals, Inc


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Efficacy and Safety of Suvratoxumab in Mechanically Ventilated Adults and Adolescents for the Prevention of Nosocomial Pneumonia

lead_sponsor: Aridis Pharmaceuticals, Inc.


title: Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies

acronym: Givinostat DMD long term study

lead_sponsor: ITALFARMACO S.p.A.


title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

lead_sponsor: Galderma S.A.


title:
An open-label, non-randomized extension study to evaluate the long term safety, tolerability, efficacy and pharmacokinetics of CDZ173 (leniolisib) in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/p110δ- activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

 Etude d’extension, en ouvert, non randomisée, évaluant la sécurité d'emploi, la tolérance et l’efficacité à long terme ainsi que la pharmacocinétique de CDZ173 (leniolisib) chez des patients atteints d’APDS/PASLI (syndrome de PI3K-delta activée/déficit immunitaire, lymphadénopathie et cellules T sénescentes dus à des mutations activatrices de p110-delta)

acronym: Extension to the study of safety and efficacy of CDZ173 in patients with APDS/PASLI

lead_sponsor: Novartis Pharma Services AG


title: Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammation and ACLF

acronym: ALADDIN

lead_sponsor: Instituto Grifols S.A.


title:
A 52-week, randomised, double-blind, placebo-controlled, parallel-group, multi-centre study of the efficacy and safety of GSK3511294 adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype

 Étude multicentrique de 52 semaines, randomisée, en double aveugle, contrôlée par placebo, à groupes parallèles, de l’efficacité et de la sécurité d’emploi du traitement adjuvant par GSK3511294 chez des patients adultes et adolescents atteints d’asthme sévère non contrôlé avec un phénotype éosinophilique.

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension

acronym: TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide

lead_sponsor: ACTELION Pharmaceuticals Ltd


title:
An open label, multi-center roll-over study to assess long-term safety in patients who are ongoing or have completed a prior global Novartis or GSK sponsored Tafinlar (dabrafenib) and/or Mekinist (trametinib) study and are judged by the investigator to benefit from continued treatment

 Etude d'extension, multicentrique, en ouvert, pour le suivi de l’innocuité à long terme de patients, recevant le Tafinlar (dabrafenib) et/ou le Mekinist (trametinib), dans le cadre d’une étude, sponsorisée par Novartis ou GSK et ayant atteint son objectif, et qui tirent un bénéfice de la poursuite du traitement selon le médecin-investigateur

lead_sponsor: Novartis Pharma AG


title: A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study

acronym: The Connection study

lead_sponsor: Infant Bacterial Therapeutics AB (IBT)


title: A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension.

acronym: The TARGET BP I Trial

lead_sponsor: Ablative Solutions, Inc


title: Tiratricol treatment of children with Monocarboxylate Transporter 8 deficiency: Triac Trial II

acronym: Triac Trial II

lead_sponsor: Rare Thyroid Therapeutics International AB


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy

lead_sponsor: Amgen Inc.


title:
Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid

 Étude de détermination de la dose, en double aveugle, randomisée, contrôlée par placebo, de phase II, comparant différentes doses de comprimés d’acide norucholique avec un placebo dans le traitement de la cholangite biliaire primitive chez des patients présentant une réponse inadéquate à l’acide ursodésoxycholique

acronym: NCA vs. placebo in PBC

lead_sponsor: Dr. Falk Pharma GmbH


title: A Phase 3, Randomized, Placebo-controlled, Double-blind Study of Vimseltinib to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor (MOTION)

acronym: MOTION

lead_sponsor: Deciphera Pharmaceuticals, LLC


title:
A PHASE 2/3, MULTICENTER, MULTINATIONAL, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALXN1101 IN NEONATES WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A

 Etude en ouvert de phase II/III, multicentrique et internationale, visant à évaluer l'efficacité et la sécurité d'emploi de l'ALXN1101 chez des nouveau-nés présentant un déficit en cofacteur molybdène (MoCoD) de type A

lead_sponsor: Alexion Pharma GmbH


title: IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH).

acronym: IMPAHCT

lead_sponsor: Aerovate Therapeutics, Inc.


title: A randomised, double-blind, parallel group, equivalence, multicentre phase III trial to compare the efficacy, safety and pharmacokinetics of HD201 to Herceptin® in patients with HER2+ early breast cancer

acronym: Troika

lead_sponsor: Prestige BioPharma Pte Ltd


title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus) (ADDRESS)

acronym: ADDRESS

lead_sponsor: argenx BV


title:
A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent  participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744

 Une étude d’extension en ouvert, multicentrique, à bras unique, visant à évaluer la sécurité d’emploi à long terme du GSK3511294 (dépémokimab) chez des patients adultes et adolescents atteints d’asthme sévère présentant un phénotype éosinophilique et issus des études 206713 ou 213744


title:
Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical trial.

 Efficacité de l'association de la simvastatine et de la rifaximine chez les patients présentant une cirrhose décompensée pour prévenir la survenue de défaillances d’organes (ACLF pour acute on chronic liver failure): un essai clinique randomisé, multicentrique, en double aveugle, contrôlé contre placebo

lead_sponsor: IDIBAPS


title: A Phase III, Randomized, Open-label, Clinical Trial to Compare Pembrolizumab with Brentuximab Vedotin in Subjects with Relapsed or Refractory Classical Hodgkin Lymphoma

acronym: Phase III trial of pembrolizumab or brentuximab vedotin in Hodgkin lymphoma

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


title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Safety and Efficacy of Ertugliflozin (MK-8835/PF-04971729) in Pediatric Participants (ages 10 to 17 years, inclusive) with Type 2 Diabetes Mellitus

acronym: Ertugliflozin T2DM Pediatric Study (MK-8835/PF-04971729)

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


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants with Primary Warm Autoimmune Hemolytic Anemia (PATHWAY)

acronym: PATHWAY

lead_sponsor: Incyte Corporation


title:
A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC)

 Étude randomisée de phase 2a, de détermination de la dose, en double aveugle, contrôlée par placebo, évaluant la sécurité, la tolérance et la pharmacocinétique de PLN-74809 chez des participants présentant une cholangite sclérosante primitive (CSP) et une fibrose hépatique suspectée (INTEGRIS-PSC)

lead_sponsor: Pliant Therapeutics, Inc


title: Pediatric Options for Migraine Relief: A randomized, double-blind, placebo-controlled study of lasmiditan for acute treatment of migraine

lead_sponsor: Eli Lilly and Company


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)

acronym: Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy  (ATTR-PN)

lead_sponsor: Eidos Therapeutics, Inc.


title: An international multicenter phase II randomized trial evaluating and comparing two intensification treatment strategies for metastatic neuroblastoma patients with a poor response to induction chemotherapy

acronym: VERITAS

lead_sponsor: Gustave Roussy


title: An Open-Label, Multicenter, Follow-up Trial of ARGX-113-1904 to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Pemphigus

acronym: ADDRESS+


title:
Tamoxifen in Duchenne muscular dystrophy - TAMDMD A multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial

 Le tamoxifène dans la dystrophie musculaire de Duchenne – TAMDMD Étude de phase 3 multicentrique, randomisée, en double aveugle, contrôlée contre placebo visant à évaluer la sécurité et l'efficacité pendant 48 semaines

lead_sponsor: University of Basel Children's Hospital, Division of Neuropediatrics


title: A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS

lead_sponsor: F. Hoffmann-La Roche Ltd


title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Adeno-associated Virus Serotype 8-mediated Gene Transfer of Glucose-6-phosphatase in Patients With Glycogen Storage Disease Type Ia.

 EMA Decision number on PIP: EMA/PDCO/154270/2021

lead_sponsor: Ultragenyx Pharmaceutical Inc.


title: A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial

acronym: Ship-CT study

lead_sponsor: Erasmus MC


title:
A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female children with protocadherin 19 (PCDH19)-related epilepsy followed by long-term open-label treatment

  Un essai en double aveugle, randomisé, contrôlé par placebo portant sur le traitement d’appoint à base de ganaxolone chez des enfants de sexe féminin atteints d’épilepsie liée à la protocadhérine 19 (PCDH19) suivi d’un traitement à long terme en ouvert

lead_sponsor: Marinus Pharmaceuticals, Inc.


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease Dementia

lead_sponsor: Karuna Therapeutics


title: An open-label, multi-center, Phase IV, roll-over study in patients with ALK positive malignancies who have completed a prior Novartis-sponsored ceritinib (LDK378) study and are judged by the investigator to benefit from continued treatment with  ceritinib.

lead_sponsor: Novartis Pharma Services AG


title: Phase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy

acronym: SAPPHIRE

lead_sponsor: Scholar Rock, Inc.


title:
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD

 ÉTUDE DE PHASE 2 RANDOMISÉE EN DOUBLE AVEUGLE CONTRÔLÉE PAR PLACEBO VISANT À ÉVALUER L'EFFICACITÉ, LA SÉCURITÉ ET LA TOLÉRANCE DU PONSEGROMAB CHEZ LES PATIENTS ATTEINTS D'UN CANCER, DE CACHEXIE ET D'UNE CONCENTRATION ÉLEVÉE EN GDF15, SUIVIE D'UNE PÉRIODE DE TRAITEMENT EN OUVERT FACULTATIVE

lead_sponsor: Pfizer Inc.


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Adult Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

lead_sponsor: Enanta Pharmaceuticals, Inc.


title:
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)

 Etude de phase III, multicentrique, randomisée en double aveugle, en groupes parallèles, contrôlée contre placebo, et composée de 3 parties, permettant de démontrer l’efficacité et la sécurité d’emploi du benralizumab, chez des patients présentant une gastrite/gastroentérite à éosinophiles (HUDSON GI)

acronym: HUDSON GI

lead_sponsor: AstraZeneca AB


title: A Phase 1/2 randomized, observer-blinded, multi-country study to  evaluate safety and immunogenicity of investigational adjuvanted human papillomavirus vaccine in females (16 to 26 years of age)

lead_sponsor: GlaxoSmithKline Biologicals SA


title:
An open label, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have completed PNH Phase 2 and Phase 3 studies with iptacopan.

 Etude d’extension en ouvert, multicentrique, ayant pour but de caractériser la tolérance et la sécurité d’emploi à long terme de l’iptacopan (LNP023) chez des patients atteints d’hémoglobinurie paroxystique nocturne (HPN) ayant terminé des études de phase II et III évaluant l’iptacopan

lead_sponsor: Novartis Pharma AG


title:
An Open-Label, Multi-Centre, Randomised Study to Investigate Integrase Inhibitor Versus Boosted Protease Inhibitor Antiretroviral Therapy for Patients with Advanced HIV Disease. The Late Presenter Treatment Optimisation Study (LAPTOP).

 Étude en ouvert, multicentrique, randomisée, visant à étudier le traitement antirétroviral par inhibiteur de l’intégrase, par rapport au traitement antirétroviral par inhibiteur de la protéase boosté, chez des patients atteints du VIH de stade avancé. Etude d’optimisation du traitement des patients dépistés tardivement (LAPTOP : The Late Presenter Treatment Optimisation Study)

acronym:
LAPTOP - Late Presenter Treatment Optimisation Study

 LAPTOP - Etude d’optimisation du traitement des patients dépistés tardivement

lead_sponsor: NEAT ID Foundation


title:
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD
 in Ocular Hypertensive or Glaucomatous Patients.

lead_sponsor: Laboratoires THEA


title:
A Phase IIIb, Open Label Extension Study Evaluating The Safety And Tolerability of AMX0035 Up To 108 Weeks In Adult Participants with Amyotrophic Lateral Sclerosis (ALS) Previously Enrolled In Study A35-004 (PHOENIX)

 Etude d’extension de phase IIIb menée en ouvert visant à évaluer la sécurité et la tolérance de l’AMX0035 jusqu’à 108 semaines chez des patients adultes atteints de sclérose latérale amyotrophique (SLA)précédemment inclus dans l’étude A35-004 (PHOENIX)

acronym: OLE Phoenix

lead_sponsor: Amylyx Pharmaceuticals Inc.


title: A Long-term Follow-up Study of Subjects With β-thalassemia or Sickle Cell Disease Treated with Autologous CRISPR-Cas9 Modified Hematopoietic Stem Cells (CTX001)

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A Randomized, Double-Blind, Placebo-Controlled Dose Range Finding Study with Open-Label Extension to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LMI070/branaplam when Administered as Weekly Oral Doses in Participants with Early Manifest Huntington’s Disease


title:
An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long Term Safety and Efficacy of APL-2 in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).

 ÉTUDE D’EXTENSION EN OUVERT, NON RANDOMISEE, MULTICENTRIQUE VISANT A EVALUER L’EFFICACITE ET LA SECURITE D’EMPLOI A LONG TERME DE L’APL-2 CHEZ DES PATIENTS ATTEINTS D’HEMOGLOBINURIE PAROXYSTIQUE NOCTURNE (HPN)

lead_sponsor: Apellis Pharmaceuticals, Inc.


title:
An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis.
 Other PIP decision number: P/0191/2014

 Un essai à bras unique en ouvert et intégré portant sur l’innocuité et la pharmacocinétique du daprodustat pour le traitement de l’anémie associée à une insuffisance rénale chronique chez les enfants et les adolescents de sexe masculin et féminin âgés de 3 mois à moins de 18 ans nécessitant ou non une dialyse.

acronym: ASCEND-P

lead_sponsor: GlaxoSmithKline Research & Development Limited


title:
A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

 Une étude pivot, en double aveugle, randomisée, contrôlée par placebo, multinationale du SGX942 (Dusquetide) pour le traitement de la mucite buccale chez des patients recevant une chimioradiothérapie concomitante pour traiter le carcinome à cellules squameuses de la tête et du cou

lead_sponsor: Soligenix UK Limited


title: A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB GIVEN IN COMBINATION WITH CABOZANTINIB VERSUS CABOZANTINIB ALONE IN PATIENTS WITH INOPERABLE, LOCALLY ADVANCED, OR METASTATIC RENAL CELL CARCINOMA WHO EXPERIENCED RADIOGRAPHIC TUMOR PROGRESSION DURING OR AFTER IMMUNE CHECKPOINT INHIBITOR TREATMENT

lead_sponsor: F. Hoffman-La Roche Ltd.


title: A Multicenter, Randomized, Double-blind, Placebo- and Active controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 years old) With Schizophrenia

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.


title: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

acronym: Assessment of safety & antitumor activity of GSK3377794 in NY-ESO-1+ and/or LAGE-1a+ solid tumors

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

summary: Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Bayer

location_country:
France
Germany
Poland
Colombia
Russian Federation
Slovenia
Slovakia
Argentina
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
China
Philippines
Greece
Indonesia
Czech Republic


title: Prophylactic Treatment With Recombinant Factor VIIa (rFVIIa, NovoSeven®) in Haemophilia Patients With Inhibitors

acronym: PROPACT

summary: This study is conducted in Europe and North and South America. The primary aim of this observational study is to evaluate the frequency and pattern of bleeding episodes in haemophilia patients receiving preventative treatment with activated recombinant human factor VII. The secondary aim is to evaluate which patients are selected for this treatment, the dose and dose intervals used, and the safety of activated recombinant human factor VII when used as prevention. The study also aims to increase understanding of the unmet medical need and clinical relevance of preventative treatment in haemophilia patients.

time_perspective: Retrospective

lead_sponsor: Novo Nordisk A/S

location_country:
France
Germany
Ireland
Italy
Slovakia
United Kingdom
Argentina
Sweden
Switzerland
United States
Spain
Croatia
Canada
Czech Republic


title: A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain

summary: This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

status: Withdrawn

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Bausch Health Americas, Inc.

sponsor_collaborators:
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.

location_country:
United States
Spain
Canada
France


title: A Multicentre, Randomised, Double-Blind, Placebo Controlled, Phase II Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide (CUV1647) for the Prophylactic Treatment of Pre-Cancerous Skin Lesions of the Head, Forearms and Hands in Immune Compromised, Organ Transplant Patients.

summary:
The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

status: Unknown status

study_completion_date_type: Anticipated

primary_purpose: Prevention

enrollment_type: Anticipated

lead_sponsor: Clinuvel Pharmaceuticals Limited

location_country: Germany Italy Australia Sweden Switzerland Belgium France

location_facility:
Charité Univeritätsklinikum
The Queen Elizabeth Hospital
Universitätsspital Zürich
The Royal Melbourne Hospital
The Princess Alexandra Hospital
University of Padua
Kiel University Hospital
Ospedali Riuniti di Bergamo
Karolinska University Hospital
Gent University Hospital
Hospital Erasme
University Hospital


title: A Phase III Study With Freeze Dried HL10, Three Dosages of 200 mg/kg Ideal Body Weight Versus Standard Therapy in ALI/ARDS Patients

summary: The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy

status: Terminated

ReferenceCitation: Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.

ReferenceCitation: Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.

lead_sponsor: LEO Pharma

location_country:
Finland
Germany
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Spain
Canada
France

location_facility: Allgemeines Krankenhaus, Klinik für Anästhesie un Allgemeine Intensivmedizin

location_facility: Klinik für Anästhesiologie der RWTH Aachen

location_facility: Ullevål University Hospital, INtensive Care Department

location_facility: University Hospital of Lund, Department of Intensive Care

location_facility: Kuopio University Hospital, Intensive Care Unit

location_facility: St Thomas Hospital, Adult Intensive Care

location_facility: Hôpital Pitié Salpétrière, Département d'Anesthésie Réanimation

location_facility: Mount Sinai Hospital, Critical Care Unit


acronym: GETGOAL-L

lead_sponsor: Sanofi

summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

ReferenceType: result

ReferenceCitation: Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. Adding once-daily lixisenatide for type 2 diabetes inadequately controlled by established basal insulin: a 24-week, randomized, placebo-controlled comparison (GetGoal-L). Diabetes Care. 2013 Sep;36(9):2489-96. doi: 10.2337/dc12-2454. Epub 2013 Apr 29.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: American Diabetes Association

ReferenceCitation: Davidson JA, Stager W, Paranjape S, Berria R, Leiter LA. Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data. Clin Diabetes Endocrinol. 2020 Jan 14;6:2. doi: 10.1186/s40842-019-0088-5. eCollection 2020.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis. J Diabetes Complications. 2014 Nov-Dec;28(6):880-6. doi: 10.1016/j.jdiacomp.2014.07.007. Epub 2014 Jul 18.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repository_institution: University of Leicester - Leicester Research Archive

title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin

type: EudraCT Number

location_country:
Germany
Italy
Russian Federation
India
United Kingdom
Brazil
Mexico
United States
Korea, Republic of
Turkey
Chile
Canada
Puerto Rico
Egypt
France


title: A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

summary: This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

lead_sponsor: Novartis

location_country:
Finland
Germany
India
Norway
Argentina
Australia
Costa Rica
Sweden
Spain
Canada
Russian Federation
France


acronym: EGN

lead_sponsor: Pfizer

summary: To demonstrate the effect on height and psychomotor development of Growth Hormone treatment in very young children starting at an age of 2 years.

ReferenceCitation: De Schepper J, Vanderfaeillie J, Mullis PE, Rooman R, Robertson A, Dilleen M, Gomez R, Wollmann HA. A 2-year multicentre, open-label, randomized, controlled study of growth hormone (Genotropin(R)) treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN) Study. Clin Endocrinol (Oxf). 2016 Mar;84(3):353-60. doi: 10.1111/cen.12968. Epub 2015 Nov 25.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

location_facility: Policlinico Universitario, Istituto di Clinica Pediatrica

location_facility: Fakultni nemocnice Ostrava, Detska klinika

location_facility: Dipartimento Materno Infantile, UO di Pediatria e Neonatologia

location_facility: Dipartimento di Medicina Pediatrica, UO di Endocrinologia e Diabetologia

location_facility: Drottning Silvias Barn och Ungdomssjukhus

location_facility: Centro di Endocrinologia Pediatrica, Dipartimento di Pediatria

location_facility: Universitair Ziekenhuis Antwerpen / Pediatrie

location_facility: CHU Toulouse, Hôpital des Enfants, Service Endocrinologie

location_facility: Universitaetsklinikum Erlangen, Kinder- und Jugendklinik

title: A Two Year Multicentre, Randomized Two Arm Study Of Genotropin Treatment In Very Young Children Born Small For Gestational Age: Early Growth And Neurodevelopment(Egn)

type: Other Identifier

location_country:
Germany
Italy
Sweden
Netherlands
Switzerland
Belgium
Spain
Czech Republic
France


title: Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of AT1001 in Patients With Fabry Disease

summary: Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease

lead_sponsor: Amicus Therapeutics

location_country:
United Kingdom
Australia
Brazil
United States
France


title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients

summary: The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

lead_sponsor: Genmab

location_country:
United Kingdom
Netherlands
Belgium
United States
France

location_facility: The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust

location_facility: CHU Sart-Tilman Domaine Universitaire du Sart-Tilman


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults With Moderately Severe Crohn's Disease

summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Parallel-Group Study to Evaluate the Safety and Efficacy of CC-5013 in the Treatment of Adolescents and Adults with Moderately Severe Crohn's Disease

ReferenceType: background

ReferenceCitation: Mansfield JC, Parkes M, Hawthorne AB, Forbes A, Probert CS, Perowne RC, Cooper A, Zeldis JB, Manning DC, Hawkey CJ. A randomized, double-blind, placebo-controlled trial of lenalidomide in the treatment of moderately severe active Crohn's disease. Aliment Pharmacol Ther. 2007 Aug 1;26(3):421-30. doi: 10.1111/j.1365-2036.2007.03385.x.

lead_sponsor: Celgene Corporation

location_country:
United States
Israel
United Kingdom
France

location_facility: Department of Gastroenterology and Hepatology

location_facility: Washington Hospital Center Physicians Office Building

location_facility: Department of Medicine A, Liver & Gastroenterology Units


title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Response, Multicentre, Multinational Study Evaluating the Efficacy and Safety of AVE2268 Administered Either Twice Daily (Breakfast and Lunch) at a Dose of 300, 600 and 1200 mg or Once Daily (Breakfast) at a Dose of 1200 mg, in Patients With Type 2 Diabetes Treated With Metformin and Not Adequately Controlled

summary:
Dose-ranging study of AVE2268 in the management of patients with type 2 diabetes mellitus also receiving metformin.

Its main objectives will be to assess the effects of several doses of AVE2268 on Mean Plasma Glucose. Its secondary objectives will be to assess the effects of AVE2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of AVE2268.

location_country:
Germany
Italy
Poland
Argentina
Denmark
Australia
Netherlands
Belgium
South Africa
Chile
France


title: A Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Noninferiority Study Comparing 75mg Risedronate Dosed on 2 Consecutive Days Monthly With 5mg Daily Risedronate in the Treatment of Postmenopausal Osteoporosis as Assessed Over 24 Months.

summary:
To confirm the non-inferiority of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate tablets taken daily in increasing bone mass in lumbar spine in postmenopausal women with osteoporosis.

To confirm the efficacy of 75 mg risedronate tablets taken on 2 consecutive days per month in postmenopausal women with osteoporosis in increasing bone mass in proximal femur, femoral neck and femoral trochanter and decreasing bone resorption.

To confirm general safety of 75 mg risedronate tablets taken on 2 consecutive days per month as compared to 5 mg risedronate taken daily.

sponsor_collaborators:
Sanofi
Procter and Gamble

location_country:
France
Poland
United Kingdom
Argentina
Australia
Lebanon
United States
South Africa
Turkey
Canada
Czech Republic


title: Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth. A Clinical, Multi-center, Prospective, Non-Randomized Study

summary:
This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-procedure. All patients will have a repeat angiography at 6 months follow-up.

The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions. The Genous stent received CE mark for the intended indication in August 2005

design_allocation: Non-Randomized

ReferenceCitation: den Dekker WK, Houtgraaf JH, Onuma Y, Benit E, de Winter RJ, Wijns W, Grisold M, Verheye S, Silber S, Teiger E, Rowland SM, Ligtenberg E, Hill J, Wiemer M, den Heijer P, Rensing BJ, Channon KM, Serruys PW, Duckers HJ. Final results of the HEALING IIB trial to evaluate a bio-engineered CD34 antibody coated stent (GenousStent) designed to promote vascular healing by capture of circulating endothelial progenitor cells in CAD patients. Atherosclerosis. 2011 Nov;219(1):245-52. doi: 10.1016/j.atherosclerosis.2011.06.032. Epub 2011 Jun 25.

lead_sponsor: OrbusNeich

location_country:
Germany
United Kingdom
Netherlands
Austria
Belgium
France

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

intervention_type: Device


title: A Double-Blind, Multi-Center, Multinational, Randomized Withdrawal Study Evaluating the Efficacy and Safety of SR58611A (350mg q12) Versus Placebo in the Prevention of Depression Relapse up to 1 Year in Patients With Major Depressive Disorder Improved After 12 Weeks of Open Treatment With SR58611A (350mg q12)

acronym: CALYPSO

summary: The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

location_country:
Finland
France
Poland
Slovakia
Argentina
Romania
Mexico
South Africa
Croatia
Bulgaria
Serbia
Russian Federation
Czech Republic


title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Fixed-Dose Study Evaluating the Effect of One Dose of Rimonabant (20 mg/Day) on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled With Insulin

summary:
Primary: Effect on HbA1c over 48 weeks in insulin-treated patients with type 2 diabetes

Secondary: Effect on glucose, total daily insulin dose, body weight, waist circumference, HDL-cholesterol, triglycerides - Safety, tolerability

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Netherlands
United States
South Africa
Chile
Canada
Russian Federation
France