title: An eight-week double-blind, multi-center, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren 75mg, 150mg and 300mg in elderly patients with essential hypertension when given with a light meal


title: An open-label, randomized, multicenter, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alfa 2b administered every 4 weeks plus ribavirin in interferon alfa-naïve patients with genotype 2/3 chronic hepatitis C

source: euctr

lead_sponsor: Novartis Pharma Services AG

study_type: Interventional

status: Completed

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3 Safety and Efficacy Study of Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


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.

lead_sponsor: H. Lundbeck A/S

status: Ongoing

status_simplified: Ongoing


title: A Phase IIb/III Randomized, Placebo-controlled Clinical Trial to Study the Safety and Efficacy of MK-0364 in Obese Patients and in Overweight Patients with Obesity-related Co-morbidities.

lead_sponsor: Laboratoires Merck Sharp & Dohme-Chibret

status: Prematurely Ended

status_simplified: Unknown


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 randomized, eight-week double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren / amlodipine (300/5 mg and 300/10 mg) in comparison with aliskiren 300 mg in patients with essential hypertension not adequately responsive to aliskiren 300 mg monotherapy.


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: A dose-finding study of efficacy and safety of F13640  in patients with moderate to severe painful peripheral diabetic polyneuropathy

acronym: BEST- Diabetes study (Befiradol Dose-Finding Study in diabetic patients)

lead_sponsor: Institut de Recherche Pierre Fabre


title: Multi-center, prospective trial to demonstrate Improved Metabolic control of PPEN vs DDDD in DIAbetic CAPD patients -The IMPENDIA Trial

acronym: IMPENDIA

lead_sponsor: Baxter Healthcare Corporation


title:
First international Inter-Group Study for nodular
 lymphocyte predominant Hodgkin`s Lymphoma in Children and Adolescents

lead_sponsor: Martin Luther University of Halle/Wittenberg

lead_sponsor_type: academique


title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)

lead_sponsor: Abbott GmbH & Co. KG


title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

lead_sponsor: Allergan Limited


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:
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


title: Multinational, multicenter, prospective, long-term safety and efficacy follow-up study after Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns (HOLOCORE-FU)

acronym: HOLOCORE FU

lead_sponsor: Chiesi Farmaceutici S.p.A.


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 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 Long-Term, Open-Label Safety and Efficacy Study of Xyrem (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


title: A Multicenter, Randomized, Double-Blind, “Crossover” Design Study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet Compared to MK 0524A + Simvastatin Coadministration in Patients With Primary Hypercholesterolemia and Mixed Dyslipidemia.


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: An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

acronym: RESTORE™ S

lead_sponsor: PDL BioPharma, Inc.


title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control


title: A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

lead_sponsor: Archimedes Development Ltd.


title: Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

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


title:
Study NOG112264, a Phase II Study of Ozanezumab
 (GSK1223249) versus Placebo in the Treatment of Amyotrophic
 Lateral Sclerosis

acronym: Ozanezumab Phase II study in patients with ALS

lead_sponsor: GlaxoSmithKline Research and Development Limited


title: Long-Term Follow-Up of Subjects in a Phase 2 or 3 Clinical Trial in which SCH 503034 was Administered for the Treatment of Chronic Hepatitis C

lead_sponsor: Schering-Plough Research Institute


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: NEMO1 : An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.

lead_sponsor: Great Ormond Street Hospital for Children NHS Trust


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: 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: 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: Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adolescents: Real-World, Open-Label, Quality of Life Study

acronym: Quality of Life study of AR101 CODIT

lead_sponsor: Aimmune Therapeutics, Inc.


ReferenceType: derived

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.

name: Hôpital Pitié Salpêtrière and Sorbonne Université Paris France

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

sequence: first

name: Department of Gastroenterology Virginia Commonwealth University Richmond VA

family: Sanyal

full_name: Arun Sanyal

given: Arun

sequence: additional

name: Pinnacle Clinical Research San Antonio TX

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

name: Department of Medicine and Therapeutics Chinese University of Hong Kong Hong Kong People's Republic of China

family: Wong

full_name: Vincent Wai‐Sun Wong

given: Vincent Wai‐Sun

name: Gastroenterology and Hepatology Antwerp University Hospital University of Antwerp Antwerp Belgium

family: Francque

full_name: Sven Francque

given: Sven

name: Center for Liver Diseases Inova Fairfax Medical Campus Falls Church VA

family: Goodman

full_name: Zachary Goodman

given: Zachary

name: NIHR Nottingham Biomedical Research Centre Nottingham University Hospitals NHS Trust and University of Nottingham Nottingham UK

family: Aithal

full_name: Guruprasad P. Aithal

given: Guruprasad P.

name: Liver Care Network Swedish Medical Center Seattle WA

family: Kowdley

full_name: Kris V. Kowdley

given: Kris V.

family: Seyedkazemi

full_name: Star Seyedkazemi

given: Star

family: Fischer

full_name: Laurent Fischer

given: Laurent

name: Division of Gastroenterology Department of Medicine University of California San Diego, La Jolla CA

name: NAFLD Research Center Department of Medicine University of California San Diego, La Jolla CA

family: Loomba

full_name: Rohit Loomba

given: Rohit

name: Division of Gastroenterology & Hepatology Department of Medicine Duke University Durham NC

family: Abdelmalek

full_name: Manal F. Abdelmalek

given: Manal F.

name: Department of Medicine III University Hospital Aachen Aachen Germany

name: Department of Gastroenterology & Hepatology Charité University Medical Center Berlin Berlin Germany

family: Tacke

full_name: Frank Tacke

given: Frank

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Hepatology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/5069801/1/cenicriviroc 2020 accepted hep.31108

url_for_landing_page: https://nottingham-repository.worktribe.com/5069801/1/Cenicriviroc 2020 Accepted Hep.31108

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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.

family: Lefebvre

full_name: Eric Lefebvre

given: Eric

family: Moyle

full_name: Graeme Moyle

given: Graeme

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.

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

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

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.


title: Randomized phase III study comparing vinflunine-gemcitabine and gemcitabine-carboplatin combinations in patients ineligible to cisplatin with advanced or metastatic urothelial carcinoma.

lead_sponsor: PIERRE FABRE MEDICAMENT


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 III Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, GT5, and GT6 Infection who are on Opiate Substitution Therapy.

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


title: A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.

lead_sponsor: Instituto Grifols, S.A

status: Not Authorised


title: Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial

acronym: INFAST

lead_sponsor: Schering-Plough Research Institute, a Division of Schering Corporation


title: A PHASE 3, OPEN-LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF AA4500 ADMINISTERED TWICE PER TREATMENT CYCLE FOR UP TO FOUR TREATMENT CYCLES (2 x 4) IN MEN WITH PEYRONIE’S DISEASE

acronym: Open Label Study of AA4500 in Men With Peyronie's Disease

lead_sponsor: Auxilium UK Limited


title: Randomized phase II study assessing the combination of Vinflunine with Gemcitabine and Vinflunine with Carboplatin in patients ineligible to cisplatin with advanced or metastatic transitional cell carcinoma of the urothelium


title: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV and Hepatitis C

lead_sponsor: Schering Plough Research Institute, A Division of Schering Corporation


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 prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids

lead_sponsor: AB Science

status: Prohibited by CA


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 IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate"

lead_sponsor: Merck & Co., Inc.


title: A multicenter, double-blind, randomized, 52 week extension study to evaluate the long term safety, tolerability and efficacy of aliskiren compared to enalapril in pediatric hypertensive patients 6-17 years of age

lead_sponsor: Novartis Pharma Services AG


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 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


title: A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the combination regimen of MK-5172 and MK-8742 +/-Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

acronym: MK-5172 + MK-8742 +/- Ribavirin Pilot Study in GT1 TN Patients

lead_sponsor: Merck Sharp & Dohme Corp.


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 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: 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


title: A phase 2b/3, randomized, double blind, dose confirming study of the safety, efficacy and tolerability of apricitabine versus lamivudine in treatment-experienced HIV-1 infected patients with the M184V/I mutation in reverse transcriptase

lead_sponsor: Avexa Limited


title: A double-blind, randomized, multicenter, parallel group study to evaluate the efficacy, tolerability, and safety of treatment with the combination of valsartan/amlodipine 160/5 mg compared to amlodipine 10 mg in patients with essential hypertension not adequately controlled with amlodipine 5 mg alone


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:
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 Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy

lead_sponsor: Flamel Ireland Limited


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: A Phase 3 Multicenter, Randomized, Double-Masked Study Comparing the Efficacy and Safety of Emixustat Hydrochloride with Placebo for the Treatment of Macular Atrophy Secondary to Stargardt Disease

acronym: The SeaSTAR Study (Safety and efficacy of EmixustAt in STARgardt disease)

lead_sponsor: Acucela Inc.


title:
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects with Moderate to Severe Chronic Plaque Psoriasis

 ÉTUDE DE PHASE 3, MULTICENTRIQUE, RANDOMISÉE, EN DOUBLE AVEUGLE, CONTRÔLÉE CONTRE PLACEBO ET COMPARATEUR ACTIF, À GROUPES PARALLÈLES, DESTINÉE À ÉVALUER L'EFFICACITÉ ET LA TOLÉRANCE DU BIMÉKIZUMAB CHEZ DES PATIENTS ADULTES PRÉSENTANT UN PSORIASIS EN PLAQUES CHRONIQUE MODÉRÉ À SÉVÈRE

lead_sponsor: UCB Biopharma SPRL


title: Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase-III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to tramadol in children from 3 months to less than 18 years of age experiencing moderate to severe chronic neuropathic or mixed pain.

acronym: Efficacy and safety study to compare gabapentin versus tramadol in paediatric patients

lead_sponsor: PHARM – Pharmaceutical Research Management srl


title:
SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in children (PENTA 17) -  A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

 SMILE: Stratégie de maintenance de la supression virale du VIH avec  un inhibiteur d'integrase administré 1 fois/jour + darunavir/ritonavir chez les enfants infectés par le VIH-1 (PENTA 17) Etude randomisée, ouverte, de phase 2/3 multicentrique, à deux bras d'étude, évaluant la sécurité et l'efficacité d'un inhibiteur d'intégrase administré 1 fois/jour en association avec darunavir/ritonavir (DRV/r)  comparé à un traitement antirétroviral standard chez les enfants infectés par le VIH-1 contrôlés virologiquement.

acronym:
PENTA 17 - SMILE

 PENTA 17 - SMILE

lead_sponsor: Fondazione PENTA ONLUS


title:
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

 Étude internationale, multicentrique, de phase III, randomisée, en ouvert comparant le MEDI4736 en association au tremelimumab ou en monothérapie à une chimiothérapie conventionnelle à base de platine chez des patients atteints d’un cancer bronchique non à petites cellules (CBNPC) de stade avancé ou métastatique en première ligne de traitement (MYSTIC)

acronym:
MYSTIC

 MYSTIC

lead_sponsor: AstraZeneca AB


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 randomized Phase 3 trial of TRC105 and pazopanib versus pazopanib alone in patients with advanced angiosarcoma (TAPPAS)

lead_sponsor: TRACON Pharmaceuticals, Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Group, Multi-Center Phase 3 Pivotal Trial to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients with Sepsis-Associated Acute Kidney Injury

lead_sponsor: AM-Pharma B.V.


title:
A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

 Etude de phase III multicentrique, randomisée, en vue d'approbation, comparant la greffe de NiCord®, cellules souches et progénitrices amplifiées ex vivo à partir de sang de cordon ombilical, et la greffe de sang de cordon ombilical non manipulé chez des patients présentant une hémopathie maligne

lead_sponsor: Gamida Cell Ltd


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:
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


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: 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: A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK-7009 Administered Concomitantly With Pegylated-Interferon and Ribavirin for 28 Days in Treatment-Naïve Patients With Chronic Hepatitis C Infection.

lead_sponsor: Laboratoires Merck Sharp & Dohme - Chibret


title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients with Sarcopenia

lead_sponsor: Laboratoires Merck Sharp & Dohme- Chibret


title: A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly)

acronym: A-CHOP-14 (elderly)

lead_sponsor: University Medicine Goettingen


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: A single arm, multicenter phase II trial of RAD001 as monotherapy in the treatment of advanced papillary renal cell cancer

acronym: RAPTOR

lead_sponsor: Novartis Pharma Services AG


title: MULTICENTRE, RANDOMIZED, DOUBLE BLIND WITHIN FREQUENCY OF ADMINISTRATION, PLACEBO CONTROLLED, DOSE-FINDING, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF 3 DOSES OF P-3058 NAIL LACQUER (5% o.d., 10% o.d., AND 10% o.w.) GIVEN FOR 52 WEEKS IN PATIENTS WITH ONYCHOMYCOSIS

lead_sponsor: Polichem SA


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 28-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression (INSURE Study)

acronym: INSURE


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

acronym: OMS

lead_sponsor: INSTITUT CURIE


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 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.

lead_sponsor: GlaxoSmithKline Research & 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 MULTI-NATIONAL, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY TO COMPARE THE SAFETY AND EFFICACY OF 200 mg PAR-101 TAKEN q12h WITH 125 mg VANCOMYCIN TAKEN q6h FOR TEN DAYS IN SUBJECTS WITH CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA

lead_sponsor: Optimer Pharmaceuticals, Inc.


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, parallel group, dose ranging study evaluating the efficacy and safety of GW642444M administered once daily compared with placebo for 28 days in adolescent and adult subjects with persistent asthma.

lead_sponsor: GlaxoSmithKline Research & Development


title: A RANDOMIZED, MULTICENTRE THERAPEUTIC CONFIRMATORY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROXINIUM™ PLUS BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE ALONE IN PATIENTS WITH ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE RECEIVED AT LEAST ONE ANTI-CANCER TREATMENT REGIMEN FOR ADVANCED DISEASE

lead_sponsor: Viventia Biotech Inc.


title: A double-blind placebo controlled study of 1g, 2g and 4g V0251 efficacy and tolerance in vestibular neuritis.

lead_sponsor: PIERRE FABRE MEDICAMENT - IRPF


title: A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a montherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB


title: A randomized, open-label, active-controlled, multicenter, parallel group study to assess the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride (HCl) formulation versus 5% amorolfine nail lacquer for 48 weeks of treatment in patients with mild to moderate toenail onychomycosis


title: Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer’s Type

lead_sponsor: Myriad Pharmaceuticals, Inc


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: An open-label study investigating long-term safety and tolearability of Nasalfent (Fentanyl Citrate Nasal Spray) in the treatment of breakthrough cancer pain (BTCP) in subjects taking regular opioid therapy

lead_sponsor: Archimedes Development Ltd


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.


title: Study of Once-Daily Versus Twice-Daily Fosamprenavir plus Ritonavir, Administered with Abacavir/Lamivudine Once-Daily in Antiretroviral-Naïve HIV-1 Infected Adult Subjects.


title: A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy.

lead_sponsor: GlaxoSmithKline Research and Development Ltd


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.


title: A 26 week treatment, randomized, multi center, double blind, double dummy, parallel-group study to assess the safety of indacaterol (300 and 600 µg o.d.) in patients with moderate to severe persistent asthma, using salmeterol (50 µg b.i.d.) as an active control.


title: A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Xyrem® (sodium oxybate) in Subjects with Fibromyalgia

lead_sponsor: Jazz Pharmaceuticals, Inc.


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

lead_sponsor: Amgen Inc.


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 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: Double-blind, randomised, placebo-controlled multicentre phase III clinical study followed by open-label phase on the efficacy and tolerability of budesonide 3 mg effervescent tablet in patients with resistant oral chronic GvHD

lead_sponsor: Dr. Falk Pharma GmbH


title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia- Study A

acronym: Phase III Safety and Efficacy Study in Primary Insomnia Patients - Study A

lead_sponsor: Merck & Co., Inc.


title: An international, multi-center, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.

acronym: Hip fracture surgery in elderly patients

lead_sponsor: AIR LIQUIDE SANTE INTERNATIONAL


title: A 52-Week Open-Label Extension and Safety Study of Pitavastatin in High-Risk Hyperlipidaemia in Childhood, P/266/2011, P/267/2011, P/268/2011

lead_sponsor: Kowa Research Europe, Ltd.


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

lead_sponsor: H. Lundbeck A/S


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: Study 200622: A randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of mepolizumab in the treatment of adolescent and adult subjects with severe hypereosinophilic syndrome

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY AND EFFICACY OF INHALED NEBULIZED PORACTANT ALFA (PORCINE SURFACTANT, CUROSURF®) IN COMPARISON WITH nCPAP ALONE

lead_sponsor: Chiesi Farmaceutici S.p.A.


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: Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites

acronym: PRECIOSA

lead_sponsor: Instituto Grifols S.A.


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: A Phase III, Multicenter, Double-Blind, Randmoized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

lead_sponsor: Laboratoires Merck Sharp & Dhome-Chibret


title: A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106.

acronym: Aquamarine

lead_sponsor: NV Organon


title: A 12-week multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design study to evaluate the efficacy on blood glucose control and safety of five doses of LCQ908 (2, 5, 10, 15 and 20 mg) or sitagliptin 100 mg on a background therapy of metformin in obese patients with type 2 diabetes

lead_sponsor: Novartis Pharma Services AG


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 facilitated access open-label, non-randomized, multicenter, long-term safety and efficacy study in Chronic Kidney Disease patients treated with SBR759 who have completed previous SBR759 studies

lead_sponsor: Novartis Pharma


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 undergoing primary, elective, open, abdominal hysterectomy.

lead_sponsor: Nycomed Danmark ApS


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 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, 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.

lead_sponsor: F. Hoffmann-La Roche Ltd


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: 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: A Phase III randomized, double blind, placebo controlled, multicenter study of panobinostat for maintenance of response in patients with Hodgkin’s lymphoma who are at risk for relapse after high dose chemotherapy and autologous stem cell transplant


title: Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF 5503/15 trial.

lead_sponsor: Grünenthal GmbH


title:
A Phase II Randomized Open Label Study of MM-121 in
 combination with Paclitaxel versus Paclitaxel alone in
 patient with Platinum Resistant/Refractory Advanced
 Ovarian Cancers.

lead_sponsor: MERRIMACK PHARMACEUTICALS


title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients from 5 to Less than 18 years of Age with Neurogenic Detrusor Overactivity (NDO)

lead_sponsor: Astellas Pharma Europe B.V.


title: A PHASE III RANDOMIZED TRIAL OF GEMCITABINE (NSC# 613327) PLUS DOCETAXEL (NSC# 628503) FOLLOWED BY DOXORUBICIN (NSC# 123127) V. OBSERVATION FOR UTERUS-LIMITED, HIGH GRADE UTERINE LEIOMYOSARCOMA

lead_sponsor: EORTC


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:
An open-label, multi-center, long-term safety follow-up, roll-over study in patients who have completed a prior Novartis-sponsored capmatinib (INC280) study and are judged by the investigator to benefit from continued treatment with capmatinib

 Étude d’extension (roll-over) et de suivi à long terme, multicentrique, en ouvert, incluant des patients qui ont terminé une étude promue par Novartis avec le capmatinib (INC280) et qui continue à tirer un bénéfice du traitement par INC280 selon le médecin-investigateur

lead_sponsor: Novartis Pharma AG


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:
A randomized, open label, multicenter phase II study evaluating the efficacy and safety of capmatinib (INC280) plus pembrolizumab versus pembrolizumab alone as first line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1≥ 50%

 Etude de phase II, randomisée, en ouvert, multicentrique, évaluant l’efficacité et l’innocuité du capmatinib (INC280) associé au pembrolizumab versus pembrolizumab en première ligne chez des patients ayant un cancer bronchique non à petites cellules localement avancé ou métastatique, avec surexpression de PD-L1 ≥ 50 %


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, Parallel Group, Multicenter, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

 Etude multicentrique de phase IIa en double aveugle, randomisée, contrôlée contre placebo et en groupes parallèles, évaluant l’efficacité et la sécurité d’emploi du Tezepelumab, chez des patients présentant une bronchopneumopathie chronique obstructive (BPCO) modérée à très sévère (COURSE)

acronym: COURSE

lead_sponsor: AstraZeneca AB


title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy.


title: Efficacy and safety of gadopiclenol for body magnetic resonance imaging (MRI)

acronym: PROMISE trial

lead_sponsor: GUERBET


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: 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 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects greater than 6 to less than 12 Years of Age

lead_sponsor: Janssen-Cilag International N.V.


title: An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome

lead_sponsor: Zogenix International Limited


title:
A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer

 Etude multicentrique randomisée de phase II en ouvert à 3 bras de traitement de LAG525 administré en association avec PDR001 (spartalizumab), ou avec spartalizumab et carboplatine, ou avec carboplatine, pour le traitement en première ou deuxième ligne de patients atteints d'un cancer du sein triple négatif à un stade avancé


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


title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib or Nivolumab and Ipilimumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

lead_sponsor: Bristol-Myers Squibb International Corporation


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: 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 multi-centre randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on the progression of left ventricular mass and diastolic function in patients with structural heart disease.

lead_sponsor: Université catholique de Louvain (UCL)


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: 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 Phase 1 Study of Durvalumab and IPH2201 in Adult Subjects with Select
 Advanced Solid Tumors

lead_sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC


title: A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age

acronym: Efficacy, immunogenicity, and safety of the 9vHPV vaccine in adult males 20 to 45 years of age

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


title:
A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

 Etude de phase III randomisée en ouvert évaluant l’efficacité et la sécurité d’emploi de l’olaparib (LynparzaTM) en comparaison à l’enzalutamide ou l’acétate d’abiratérone chez les hommes atteints d’ un cancer de prostate métastatique résistant à la castration (CPRCm), en échec d’un traitement par un agent hormonal de nouvelle génération et porteurs d’une mutation des gènes impliqués dans la voie de réparation par recombinaison homologue (HRR) (PROfound)

acronym: PROfound

lead_sponsor: AstraZeneca


title:
A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adolescent subjects (12–17 years of age) with moderate-to-severe plaque psoriasis

 Essai de phase III, multicentrique, randomisé, en double aveugle, visant à évaluer l’efficacité, la sécurité et la tolérance du traitement par brodalumab par rapport au placebo (en aveugle) et à l’ustékinumab (en ouvert) chez des adolescents (âgés de 12 à 17 ans) atteints de psoriasis en plaques modéré à sévère

acronym: EMBRACE 1

lead_sponsor: LEO Pharma A/S


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:
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: An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants

lead_sponsor: Incyte Biosciences International Sàrl


title: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency

lead_sponsor: Clovis Oncology, Inc.


title: A multicenter, multinational, randomized, double-blind, placebo-controlled study to assess the efficacy, pharmacodynamics, pharmacokinetics, safety, and tolerability of venglustat in late-onset GM2 gangliosidosis (Tay-Sachs disease and Sandhoff disease) together with a separate basket for juvenile/adolescent late-onset GM2 gangliosidosis and ultra-rare diseases within the same and similar glucosylceramide-based sphingolipid pathway

acronym: AMETHIST

lead_sponsor: Genzyme Corporation


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: 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 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: An Open-Label Roll-Over Study to Evaluate the Long-Term Safety and Efficacy of DCR PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

acronym: PHYOX 3

lead_sponsor: Dicerna Pharmaceuticals Inc


title: A Phase 1/2, Open-Label, Dose-Escalation Trial of GEN3013 in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

acronym: First-in-Human (FIH) Trial in Patients with Relapsed, Progressive or Refractory B-Cell Lymphoma

lead_sponsor: Genmab A/S


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: PACIFICA Phase 3: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)

acronym: PACIFICA

lead_sponsor: CTI BioPharma Corp.


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:
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: 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+

lead_sponsor: argenx BV


title:
A phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of tafasitamab plus lenalidomide in addition to R-CHOP versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed diffuse large B-cell lymphoma (DLBCL)

 Essai de phase 3, multicentrique, randomisé, en double aveugle, contrôlé par placebo, visant à comparer l'efficacité et l'innocuité du tafasitamab plus lénalidomide en association avec la chimiothérapie R-CHOP par rapport à la chimiothérapie R-CHOP seule chez des patients à risque intermédiaire et à risque élevé présentant un lymphome diffus à grandes cellules B (LDGCB) récemment diagnostiqué n'ayant jamais été traités

acronym: frontMIND

lead_sponsor: MorphoSys AG


title: Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer

lead_sponsor: Sanofi-aventis recherche & développement


title: A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with newly diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations eligible for intensive chemotherapy

acronym: HOVON 156 AML / AMLSG 28-18

lead_sponsor: HOVON Foundation


title: Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies

acronym: Follow-Up Study to Assess Long-Term Safety of Infants exposed to Retosiban

lead_sponsor: GlaxoSmithKline Research & Development Limited


title: An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control.

lead_sponsor: GlaxoSmithKline Research & Development 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 trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma

acronym: RTOG

lead_sponsor: EORTC


title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)


title: A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) in an Antecedent Study

lead_sponsor: NightstaRx Ltd


title: Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy.

lead_sponsor: ITALFARMACO S.p.A.


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:
An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

 Étude ouverte, randomisée, contrôlée par médicament actif, multicentrique, de phase 3, pour évaluer la sécurité et l'efficacité du danaparoïde par rapport à l'argatroban dans le traitement de sujets atteints d'une TIH aiguë (étude HITSOVA)

acronym:
HITSOVA

 HITSOVA

lead_sponsor: Aspen Global Incorporated


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 2 or 3. ACHIEVE-2/3

lead_sponsor: Human Genome Sciences, Inc.


title: Exploratory efficacy and safety, pharmacokinetics and dose-finding study of ATryn® (antithrombin alfa) in patients with disseminated intravascular coagulation associated with severe sepsis

lead_sponsor: LEO Pharma A/S


title: Study of the analgesic effects of repeated doses of F13640 in spinal cord injury patients with moderate to severe central neuropathic pain. A multinational, multicenter, randomized, double blind, parallel groups, placebo-controlled study.

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Placebo-controlled trial on the efficacy of growth hormone replacement therapy in patients with growth hormone deficiency after traumatic brain injury

lead_sponsor: Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK


title: A Phase 3, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b (alb-IFN) in Combination with Ribavirin Compared with Peginterferon Alfa-2a (PEGASYS or PEG-IFNα2a) in Combination with Ribavirin in Interferon Alfa Naïve Subjects with Chronic Hepatitis C Genotype 1.  ACHIEVE -1


title:
Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV)

 Efficacité et tolérance de l’association Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) administrée 2 fois par jour en supplément d’un traitement par l’association Travoprost 0.004% / Timolol 0.5% (DUOTRAV).

acronym: Safety and Efficacy of Simbrinza as an Adjunctive to DuoTrav

lead_sponsor: Alcon Research Ltd


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:
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:
Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis

 Long-term treatment of cancer associated VTE Optimal dose of apixaban API-CAT STUDY for APIxaban Cancer Associated Thrombosis

acronym: API-CAT

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

status: Temporarily Halted


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 MULTI-CENTRE,RANDOMISED,DOUBLE BLIND,PLACEBO CONTROLLED,PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-2506PO COMPARED TO PLACEBO,IN THE PRESENCE OF RILUZOLE,TO PATIENTS DIAGNOSED WITH AMYOTROPHIC LATERAL SCLEROSIS(ALS), WHO HAVE HAD ONSET OF MUSCLE WEAKNESS WITHIN 14 MONTHS OF RANDOMISATION

lead_sponsor: ONO Pharmaceutical Co.,Ltd


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: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore And Compare Perceptions And Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis.

lead_sponsor: Wyeth Pharmaceuticals 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 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:
DORADO-EX – A Dose-Blinded, Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension
 A Dose-Blinded, Long-Term Safety Extension Study of Fixed Doses of Darusentan in Subjects with Resistant Systolic Hypertension Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic

acronym: DORADO-EX

lead_sponsor: Gilead Sciences Inc.


title: A Randomised, Phase IIb Placebo-controlled Study of R-ICE Chemotherapy (Rituximab, Ifosfamide, Carboplatin, and Etoposide) with and without SGN-40 (anti-CD40 humanized monoclonal antibody) for Second-line Treatment of Patients with Diffuse Large B-Cell Lymphoma (DLBCL)

lead_sponsor: Seattle Genetics, Inc.


title:
DORADO-AC-EX – A Double-Blind, Active-Controlled, Long-Term Safety Extension Study to the Phase 3 DORADO-AC Study (Protocol DAR-312) of Darusentan in Resistant Hypertension
 A Double-Blind, Active-Controlled, Long-Term Safety Extension Study of Optimized Doses of Darusentan in Subjects with Resistant Hypertension Despite Receiving Combination Therapy with Three or More Antihypertensive Drugs, Including a Diuretic, as Compared to Guanfacine (Protocol DAR-312-E)

acronym: DORADO-AC-EX


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

lead_sponsor: DAIICHI SANKYO EUROPE GmbH


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 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: PHASE 4, PROSPECTIVE, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY TO EVALUATE SMOKING CESSATION WITH VARENICLINE TARTRATE COMPARED WITH PLACEBO IN THE SETTING OF PATIENT SELF-SELECTED (FLEXIBLE) QUIT DATE

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


title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study to Evaluate the Efficacy and Safety of 50 mg/day of DVS SR in Adult Outpatients With Major Depressive Disorder

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


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: 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)

lead_sponsor: F. Hoffmann-La Roche Ltd


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

lead_sponsor: Janssen-Cilag International NV


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: A Phase II, Open-Label, Randomized, Multicenter Trial of Pazopanib (GW786034) in Combination with Lapatinib (GW572016) Compared to Pazopanib Montherapy and Lapatinib Monotherapy in Subjects with FIGO Stage IVB or Recurrent or Persistent Cervical Cancer with Zero or One Prior Chemotherapy Regimen for Advanced/Recurrent Disease

lead_sponsor: GlaxoSmithKline Research & Development 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:
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: Randomized phase II trial evaluating the feasibility and tolerance of the combination of FOLFOX with cetuximab and the combination of FOLFOX with cetuximab and bevacizumab as perioperative treatment in patients with resectable liver metastases from colorectal cancer.

acronym: BOS

lead_sponsor: European Organisation for Research and Treatment of Cancer


title: A multicenter, randomized, double blind, placebo controlled Phase III study to assess the efficacy of xaliproden in patients with oxaliplatin-induced peripheral sensory neuropathy (PSN) following adjuvant chemotherapy for colon cancer

acronym: XENON

lead_sponsor: sanofi-aventis groupe


title:
A Randomized Phase II Biomarker Neoadjuvant Study of Sequential AC Followed by Ixabepilone Compared to Sequential AC Followed by Paclitaxel in Women with Early Stage Breast Cancer Not Overexpressing HER-2 and Estrogen Receptors.
 And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (Version 1.0, Date 21-Dec-2006).

lead_sponsor: Bristol-Myers Squibb International Corporation


title: Prospective, randomized, observer-blind, parallel-group, multi-center trial to assess efficacy and safety of two different dilutions of NT 201 in patients with upper limb spasticity

acronym: NT-SPIN

lead_sponsor: Merz Pharmaceuticals GmbH


title: Comparison of the safety and efficacy of eplivanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties. A 4 week, randomized, double-blind, comparative, parallel-group study.


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

lead_sponsor: AstraZeneca AB


title: Post authorisation safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v.

acronym: not applicable

lead_sponsor: Hexal Biotech ForschungsGmbH


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Schizophrenia “ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)

acronym: ASPIRE EU

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.


title: Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)

lead_sponsor: Laboratorios Almirall, S.A.


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: An Open-Label, Randomized, Phase 2 Dose-Finding Study of Pacritinib in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis Previously Treated with Ruxolitinib

lead_sponsor: CTI BioPharma Corp.


title: A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed

lead_sponsor: ViiV Healthcare UK Limited


title: A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

acronym: Firibastat in treatment-RESistant Hypertension (FRESH)

lead_sponsor: Quantum Genomics


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:
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: Phase III Randomized, Multi Center Study of Sunitinib Malate (SU 011248) or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

lead_sponsor: PFIZER


title: A   Phase III,  Randomised,  Double-blind,  Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

lead_sponsor: Mitsubishi Pharma Corporation


title: A Phase III, Double-blind, Multi-centre, Randomised, Parallel Group Design, Placebo-controlled, Flexible Dose Study of MCI-196 in Combination with a Calcium-based Phosphate Binder in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia.


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 Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects with Genotype 1 Chronic Hepatitis C

lead_sponsor: Vertex Pharmaceuticals Incorporated


title: A PHASE 2, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, INTERNATIONAL, MULTICENTER STUDY OF ORAL TAC 101 AS SECOND LINE TREATMENT IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA WHO RECEIVED SORAFENIB AS FIRST LINE THERAPY

lead_sponsor: Taiho Pharma USA, Inc.


title: A PHASE 2, OPEN-LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LENALIDOMIDE IN COMBINATION WITH CETUXIMAB IN PRETREATED SUBJECTS WITH KRAS MUTANT METASTATIC COLORECTAL CANCER

lead_sponsor: Celgene Corporation


title:
TPL108392:  An open-label, multi-centre rollover study to assess the safety and efficacy of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin)
 ENABLE-ALL (Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C Related Liver DiseasE – All Subjects Withdrawing From ENABLE 1 and 2 through Lack of Response)

acronym: ENABLE ALL

lead_sponsor: GlaxoSmithKline Research and Development Ltd


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: SIOPEL 6: Essai thérapeutique international multicentrique randomisé de phase III: Effet du thiosulfate de sodium (STS) dans la réduction de la toxicité auditive chez des patients traités par cisplatine pour un hépatoblastome de risque standard

acronym: SIOPEL 6

lead_sponsor: Centre Hospitalier Universitaire de Besançon


title: An open label, comparative, randomised, balanced crossover trial comparing nasal fentanyl and oral transmucosal fentanyl (Actiq) in breakthrough pain in patients with cancer.

lead_sponsor: Nycomed Danmark ApS


title: A SIX MONTH, OPEN-LABEL OUTPATIENT, RANDOMIZED PARALLEL GROUP TRIAL ASSESSING THE IMPACT OF DRY POWDER INHALED INSULIN (EXUBERA®) ON GLYCEMIC CONTROL COMPARED TO INSULIN GLARGINE (LANTUS®) IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE POORLY CONTROLLED ON A COMBINATION OF TWO OR MORE ORAL AGENTS

lead_sponsor: Pfizer Inc


title: A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine

lead_sponsor: AstraZeneca AB


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: 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 Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.
 And Pharmacogenetics Blood sample Amendment - Site Specific

lead_sponsor: Bristol Myers Squibb International Corporation


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: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate

lead_sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.


title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of talampanel in Subjects with Amyotrophic Lateral Sclerosis (ALS)

lead_sponsor: Teva Pharmaceutical Industries, Ltd


title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Previously Treated with TNF Antagonist Therapy

acronym: CERTIFI

lead_sponsor: Centocor BV


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.

lead_sponsor: Amgen Inc


title: A Multicenter, Randomized, Double-Masked, Parallel-Group Study Evaluating the Efficacy and Safety of Cyclosporine Ophthalmic Solution 0.010% Compared with its Vehicle Administered QID for 3 months Followed by a 9 Month Open-Label Phase in Patients with Atopic Keratoconjunctivitis.

lead_sponsor: Allergan Limited


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 randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

lead_sponsor: Mundipharma Research GmbH & Co. KG


title: Randomized Phase II of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects with Triple Negative (ER, PR, Her2 negative) Locally Advanced non-resectable and/or Metastatic Breast Cancer

lead_sponsor: Bristol-Myers Squibb International Corporation


title: A Phase 4, Multicenter, Open-Label, Assessor-blinded, Switch Study o fthe Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) of Adalimumab (HUMIRA)

acronym: RESTART


title: A dose ranging,  randomized, double blind, parallel-group  placebo-controlled  multi-center study of  RO5313534 used as add-on to donepezil treatment in patients with mild to moderate symptoms of Alzheimer’s Disease

lead_sponsor: F. Hoffmann-La Roche Ltd


title: A 24-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Add-on Compared to Uptitration of Metformin in Patients with Type 2 Diabetes Mellitus With Inadequate Glycaemic Control on Sub-Maximal Doses of Metformin

acronym: Prompt


title:
A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who Received 4 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

 Etude de phase IIIB/IV d’optimisation de la fréquence de la dose, évaluant le Nivolumab 240 mg toutes les deux semaines versus le Nivolumab 480 mg toutes les 4 semaines chez les patients atteints d’un cancer bronchique non à petites cellules avancé ou métastatique ayant reçu un traitement par le Nivolumab à une dose de 3 mg/kg ou 240 mg toutes les deux semaines pendant 4 mois

acronym: CheckMate 384: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 384


title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma

lead_sponsor: GlaxoSmithKline Research & Development Ltd


title: A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur

lead_sponsor: Wyeth Pharmaceuticals Inc.


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients with Refractory Partial Seizures

lead_sponsor: Eisai Limited


title: A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD)

acronym: CLIMB

lead_sponsor: AstraZeneca AB


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of a Single Treatment with Two Dose Levels of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex Followed by a Treatment with BOTOX® in Patients with Urinary Incontinence Due to Neurogenic Detrusor Overactivity

lead_sponsor: Allergan Ltd


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

acronym: Not applicable

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: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ORALLY ADMINISTERED PH-797804 (0.5, 3, 6 AND 10 MG) IN ADULTS WITH MODERATE TO SEVERE CHRONIC

lead_sponsor: Pfizer Ltd, Ramsgate Road, Sandwich, Kent


title: Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN (SATURN): A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease

acronym: SATURN


title: A Phase IIIb/IV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of MOVICOL® with Placebo in Patients with Constipation Associated with Irritable Bowel Syndrome (IBS)

lead_sponsor: Norgine Pharmaceuticals Ltd


title: A 48-week, multicentre, multinational, randomized, double-blind, 2-arm parallel group study, comparing the efficacy of FOSTER™ for maintenance and reliever versus fixed-dose FOSTER™ for maintenance + salbutamol as reliever in asthmatics ≥12 years of age

lead_sponsor: Chiesi Farmaceutici S.p.A.


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:
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: Impact of Tadalafil (LY450190) Once a Day or Tadalafil On Demand Compared to Sildenafil Citrate On Demand on Treatment Discontinuation in Patients with Erectile Dysfunction who are Naïve to PDE5 Inhibitors

lead_sponsor: Eli Lilly and Company Limited


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.


title: A phase III study to compare SonoVue guided prostate biopsy with systematic biopsy in the detection of prostate malignant lesions in patients with suspected prostate cancer

acronym: SonoVue guided prostate biopsy

lead_sponsor: Bracco Imaging SPA


title: A Phase 2 Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of DCR-PHXC Solution for Injection (subcutaneous use) in Patients with Primary Hyperoxaluria

acronym: PHYOX 2

lead_sponsor: Dicerna Pharmaceuticals Inc


title:
An open-label, multi-centre, randomised, switch study to evaluate the virological efficacy over 96 weeks of 2-drug therapy with DTG+RPV FDC in antiretroviral treatment-experienced HIV-1 infected subjects virologically suppressed with NNRTIs resistance mutation K103N.

 Étude switch ouverte, multicentrique, randomisée, afin d’évaluer l’efficacité virologique sur 96 semaines d’une bithérapie par association à dose fixe de DTG/RPV chez des patients infectés par le VIH-1, prétraités par des antirétroviraux, virologiquement supprimés, porteurs de la mutation K103N de résistance aux INNTI.

acronym: WISARD: acronym of SWItch Study mutAtion Rilpivirine Dolutegravir.

lead_sponsor: European AIDS Treatment Network Infectious Disease Foundation (NEAT ID)


title: A MULTICENTER, OPEN, SINGLE SEQUENCE CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF A TACROLIMUS MODIFIED RELEASE, FK506E (MR4), BASED IMMUNOSUPPRESSIVE REGIMEN IN STABLE LIVER TRANSPLANT PATIENTS CONVERTED FROM A PROGRAF BASED IMMUNOSUPPRESSIVE REGIMEN

lead_sponsor: Astellas Pharma GmbH


title: A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS.

lead_sponsor: Wyeth Pharmaceuticals, Inc.


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: PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo

lead_sponsor: Ferring Pharmaceuticals A/S


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: 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: A Phase 3 Randomized, Double-Blind, Placebo- and Oxycodone-Controlled, Multicenter Study of the Efficacy and Safety of Tanezumab in Patients with Osteoarthritis of the Knee or Hip

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


title: A Randomised, Placebo-controlled, Double-blind, Multicentre Efficacy and Safety Study of LJPC-501 in Paediatric Patients > 2 to 17 Years of Age with Catecholamine-Resistant Hypotension Associated with Distributive Shock

lead_sponsor: La Jolla Pharmaceutical Company


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 multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

lead_sponsor: GlaxoSmithKline Research & Development Limited


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, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

lead_sponsor: Applied Molecular Transport Inc.


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 1b/2 study of AMG 655 Combination with Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer

lead_sponsor: Amgen Inc