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EU Clinical Trial 2007-004190-26 – EMA – Nov 16, 2007

An open-label, single-arm, multi-center phase 2 trial with ofatumumab in patients with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Main objective of the trial: To investigate the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant
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EU Clinical Trial 2012-003534-17 – EMA – Apr 5, 2013

A phase III 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

Main objective of the trial: The objective of Cohort A is to evaluate the safety and pharmacokinetic (PK) profile of BI 207127 (potentially two doses) in combination with 120 mg once daily (q.d.) FDV and weight-based RBV in a small group of patients...
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EU Clinical Trial 2011-005409-65 – EMA – Jan 18, 2013

A Phase 3 Evaluation of Daclatasvir in Combination with Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination with Peginterferon Alfa-2a and RBV in Patients with Chronic Hepatitis C Genotype 1b who are Treatment Naïve or Prior Relapsers to Alfa/RBV Therapy (The STRUCTURE Study) Revised Protocol 03, incorporating Amendment 09 (version 1.0, dated 09-Jul-2013) + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 21-Jun-12)

Main objective of the trial: To compare the efficacy of Lambda/RBV/DCV to alfa-2a/RBV/TVR in subjects with chronic infection with HCV GT-1b, measured as the proportion of subjects who achieve SVR12 at post-treatment follow-up Week 12.
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EU Clinical Trial 2011-002715-28 – EMA – Dec 9, 2011

A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS/COPEGUS COMPARED WITH TELAPREVIR AND PEGASYS/COPEGUS IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN.

Main objective of the trial: To estimate the difference in sustained virologic response 12 weeks after treatment (SVR-12) between each of the following three experimental treatment groups (regimens containing RO5024048, telaprevir, Pegasys, and Copeg...
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EU Clinical Trial 2010-023900-29 – EMA – Aug 23, 2011

A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of Ozurdex® Versus Lucentis® in Patients with Branch Retinal Vein Occlusion.

Main objective of the trial: To compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO. Comparar la eficacia y la seguridad de Ozurdex vs. Lucentis en sujetos con ORVR.
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EU Clinical Trial 2009-012293-12 – EMA – Jan 25, 2010

BRIM 3: A Randomized, Open-label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma with V600E BRAF Mutation Receiving RO5185426 or Dacarbazine.

Main objective of the trial: To evaluate efficacy of RO5185426 as a monotherapy compared to dacarbazine in terms of overall survival (OS) in previously untreated patients with advanced melanoma harbouring the BRAF V600E mutation
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EU Clinical Trial 2008-000701-11 – EMA – Nov 25, 2008

A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined with Dasatinib to Docetaxel Combined with Placebo in Castration-Resistant Prostate Cancer Revised Protocol 03 incorporating Administrative Letter(s) 02 and Amendment(s) 05 + Protocol Amendment 01 (v1.0, date 20-Jun-2008)

Main objective of the trial: The primary objective is to compare overall survival for dasatinib plus docetaxel and prednisone versus placebo plus docetaxel and prednisone in subjects with metastatic castration-resistant prostate cancer.
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EU Clinical Trial 2011-005539-22 – EMA – Oct 8, 2012

A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF MEHD7945A VERSUS CETUXIMAB IN PATIENTS WITH RECURRENT/METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK WHO HAVE PROGRESSED DURING OR FOLLOWING PLATINUM BASED CHEMOTHERAPY

Main objective of the trial: The main objective is to evaluate the efficacy of MEHD7945A (administered every 2 weeks) versus cetuximab (administered weekly) in all and in biomarker positive patients with recurrent/metastatic squamous cell carcinoma o...
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EU Clinical Trial 2009-013552-72 – EMA – Sep 7, 2010

A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664)

Main objective of the trial: Primary Efficacy Objective: The Primary Efficacy Objective of this trial is to evaluate the efficacy of a range of preladenant doses compared with placebo in subjects with early Parkinson’s disease (PD) as measured by the...
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EU Clinical Trial 2011-002224-40 – EMA – May 14, 2012

A randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination with Tarceva® (erlotinib) in Patients with Met Diagnostic-Positive Non-Small Cell Lung Cancer (NSCLC) Who Have Received Standard Chemotherapy for Advanced or Metastatic Disease

Main objective of the trial: The primary objective of this study is to determine whether the combination of onartuzumab + erlotinib is superior (in terms of OS) to placebo + erlotinib after standard platinum-based chemotherapy in patients with Met di...
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EU Clinical Trial 2012-000660-22 – EMA – Nov 23, 2012

A randomized, multicenter, adaptive phase II/III study to evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) versus taxane (docetaxel or paclitaxel) in patients with previously treated locally advanced or metastatic HER2-positive gastric cancer, including adenocarcinoma of the gastroesophageal junction.

Main objective of the trial: To compare the overall survival (OS) of patients treated with trastuzumab emtansine with the regimen from Stage 1 of the study selected at the interim analysis to the OS of patients treated with physician’s choice of taxa...
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EU Clinical Trial 2013-003434-32 – EMA – Jan 30, 2014

A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with moderate to severe plaque psoriasis

Main objective of the trial: To demonstrate the superiority of secukinumab compared to ustekinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16
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EU Clinical Trial 2013-002511-99 – EMA – Nov 25, 2013

Role of PET/ CT with 18F-fluorocholine in the staging of patients with intermediate/high risk prostate cancer. Phase III, randomized, open-label clinical trial

Main objective of the trial: Verify whether the additional use of PET/CT with 18F-fluorocholine in the initial staging of prostate cancer improves the sensitivity in defining the loco-regional disease with respect to CT and bone scan. Verificare se l...
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EU Clinical Trial 2013-004958-18 – EMA – Jul 14, 2014

A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

Main objective of the trial: To evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%
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EU Clinical Trial 2012-004208-37 – EMA – Apr 23, 2013

A Randomized, Multi-Center, Placebo-Controlled, Parallel Group Study to Determine the Effects of AMG-145 Treatment on Atherosclerotic Disease Burden As Measured By Intravascular Ultrasound in Patients Undergoing Coronary Catheterization

Main objective of the trial: To evaluate the effect of AMG 145 on the change in burden of coronary atherosclerosis as measured by percent atheroma volume (PAV) in patients with coronary artery disease requiring angiography for a clinical indication w...
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EU Clinical Trial 2010-018365-34 – EMA – Jan 1, 2010

A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis

Main objective of the trial: Primary Objective: • To assess safety and tolerability of long-term repeat dosing of RP103 in patients with nephropathic cystinosis.
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EU Clinical Trial 2013-004069-14 – EMA – Jan 22, 2015

A european, multicentre, phase II/III randomised double-blind, placebo controlled study evaluating lanreotide as maintenance therapy in patients with non-resectable duodeno-pancreatic neuroendocrine tumours after first-line treatment

Main objective of the trial: Phase II: To evaluate the rate of patients alive and progression free at 6 months, assessed by the investigator according to RECIST criteria, version 1.1. Phase III: To assess and compare the Progression Free Survival (PF...
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EU Clinical Trial 2010-021134-66 – EMA – Jan 1, 2010

Efficacy assessment of systematic treatment with folinic acid and thyroid hormone on psychomotor development of Down Syndrome young children

Main objective of the trial: Psychomotor development efficacy assessment of two medications on Down's syndrome young children : - systematic thyroxin treatment with clinically and biologically controlled dosing, - systematic folinic acid treatment, -...
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EU Clinical Trial 2012-005287-10 – EMA – Aug 3, 2015

A Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer

Main objective of the trial: Efficacy will be assessed by comparing overall survival (OS) between the MABp1 (plus best supportive care (BSC)) and placebo (plus BSC) groups.
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EU Clinical Trial 2014-001947-18 – EMA – Jul 7, 2015

A Phase 3, Randomized, Double-blind, Sham-Procedure Controlled Study to Assess the Clinical Efficacy and Safety of ISIS 396443 Administered Intrathecally in Patients with Later-onset Spinal Muscular Atrophy

Main objective of the trial: To examine the clinical efficacy of ISIS 396443 administered intrathecally to patients with later-onset SMA. Valutare l'efficacia di ISIS 396443 somministrato per via intratecale a pazienti con SMA ad esordio tardivo
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EU Clinical Trial 2017-002630-22 – EMA – Jan 18, 2018

Pain prevention during propofol infusion in pediatric: hypnoanalgesia of the hand versus lidocaine.

Main objective of the trial: Evaluate the efficacity of hypnoanalgesia of the hand in order to reduce propofol-induced pain in children compared to the administration of a lidocaine-propofol admixture
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EU Clinical Trial 2013-000705-23 – EMA – Feb 9, 2014

A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis

Main objective of the trial: To demonstrate that at least one dose regimen of BYM338 will increase the 6 minute walking distance test relative to placebo at week 52.
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EU Clinical Trial 2010-021961-61 – EMA – May 19, 2011

A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia(VALOR)

Main objective of the trial: Compare overall survival (OS) between treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine
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EU Clinical Trial 2013-004103-40 – EMA – Mar 20, 2014

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator’s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

Main objective of the trial: The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator’s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue...
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EU Clinical Trial 2017-001019-35 – EMA – Dec 19, 2017

Effect of vitamin D deficiency compensation in the treatment of drug-resistant epilepsy.

Main objective of the trial: To evaluate the effect of vitamin D deficiency compensation on the frequency of crises in patients over 15 years of age following drug-resistant epilepsy, the percentage reduction in the number of crises after 3 months of...
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EU Clinical Trial 2011-001873-24 – EMA – Jan 13, 2012

A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension

Main objective of the trial: Main objective of the trial is to characterize the pharmacokinetics (PK) of tadalafil in a pediatric population with pulmonary arterial hypertension (PAH) to establish an appropriate dose range for further clinical resear...
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EU Clinical Trial 2008-008435-29 – EMA – Jan 1, 2008

A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia A (FVIII:C <1%)

Main objective of the trial: To evaluate the pharmacokinetics and incremental recovery of ReFacto AF in pediatic subjects less than 12 years of age after a single exposure to ReFacto AF.
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EU Clinical Trial 2017-003105-18 – EMA – Dec 13, 2017

A randomized, placebo-controlled, evaluator-blinded, study to assess the anti-inflammatory effects of topical erythromycin and clindamycin in patients with inflammatory facial acne

Main objective of the trial: Objectives • To evaluate the effects of topically applied erythromycin and clindamycin in patients with facial AV • To explore skin and faecal microbiota in patients with AV; • To evaluate the effects of topically applied...
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EU Clinical Trial 2015-003697-32 – EMA – Dec 22, 2015

A multi-centre, open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma not optimally controlled with current omalizumab treatment who are switched from omalizumab to mepolizumab 100mg subcutaneous (study number 204471- the OSMO study)

Main objective of the trial: To describe in a pragmatic setting whether there is an improvement in asthma control, from the beginning to the end of the study, when directly switched to mepolizumab, in subjects with a severe eosinophilic asthma phenot...
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EU Clinical Trial 2014-000726-37 – EMA – Nov 24, 2014

A phase Ib/II, multicenter, open-label study of EGF816 in combination with INC280 in adult patients with EGFR mutated non-small cell lung cancer

Main objective of the trial: Phase Ib part: To estimate the MTD or RP2D of EGF816 in combination with INC280 Phase II part: To estimate the preliminary anti-tumor activity of EGF816 in combination with INC280 Parte de la fase Ib: Calcular la DMT o DR...
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EU Clinical Trial 2011-000392-14 – EMA – Jul 27, 2011

LUX-Head & Neck 2 A randomised, double-blind, placebo-controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb loco-regionally advanced head and neck squamous cell carcinoma

Main objective of the trial: To investigate the efficacy of afatinib over placebo when given as adjuvant therapy after chemo-radiotherapy (CRT) in primary unresected patients with loco-regionally advanced squamous cell carcinoma stage III or IVa/b of...
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EU Clinical Trial 2015-005389-51 – EMA – Oct 6, 2017

Safety and Efficacy of tocilizuMAb versus placebo in Polymyalgia rHeumatica with glucocORticoid dEpendence SEMAPHORE

Main objective of the trial: To demonstrate the ability of tocilizumab in comparison to placebo to decrease GCs (prednisone or prednisolone) and to maintain low disease activity at week 24 in steroid dependent PMR patients
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EU Clinical Trial 2011-002143-95 – EMA – Oct 4, 2012

A Multicenter, Randomized, Double-blind, Placebo- and Active-Controlled Study Comparing the Safety and Analgesic Efficacy of ABT-110 to Placebo in Subjects with Chronic Low Back Pain

Main objective of the trial: The primary objective for this study is to compare the safety, tolerability and the analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of two doses to placebo in subjects w...
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EU Clinical Trial 2015-002022-39 – EMA – Sep 24, 2015

A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Obinutuzumab in patients with ISN/RPS 2003 class III or IV Lupus Nephritis

Main objective of the trial: • To evaluate the efficacy of obinutuzumab compared with placebo in patients with International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III or IV Lupus Nephritis (LN) as measured by complete renal...
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EU Clinical Trial 2012-001547-46 – EMA – Aug 22, 2012

Phase I followed by phase II study of the combination of trastuzumab emtansine (T-DM1) and capecitabine in HER2-positive metastatic breast cancer and HER2-positive locally advanced or metastatic gastric cancer patients

Main objective of the trial: Phase 1: To determine the Maximum Tolerated Dose (MTD) of the combination of trastuzumab emtansine and capecitabine in metastatic breast cancer (mBC) and metastatic gastric cancer (mGC) patients. Phase 2: ORR by investiga...
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EU Clinical Trial 2012-003065-17 – EMA – May 16, 2013

An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer

Main objective of the trial: The primary objective is to estimate progression-free survival in patients treated with everolimus + letrozole in the first line metastatic setting.
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EU Clinical Trial 2006-001985-17 – EMA – Oct 25, 2006

An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine, and Oxaliplatin plus Oral Enzastaurin as Treatment for Patients with Relapsed Diffuse Large B-Cell Lymphoma

Main objective of the trial: Main objective : evaluation of progression free survival on R-GEMOX and enzastaurin, 1 year after treatment start, in patients with relapsed DLBCL or transformed (CD20+) indolent lymphoma, who are older than 60 years. Pat...
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EU Clinical Trial 2010-023550-36 – EMA – Apr 6, 2011

A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients with DSM-IV-TR Schizophrenia Followed by Open-Label Treatment with LY2140023

Main objective of the trial: The primary objective of this study is to test the hypothesis that mean weight gain, as assessed by change from baseline, will be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg BID) than f...
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EU Clinical Trial 2016-002580-34 – EMA – Sep 6, 2016

A double blind placebo controlled study to evaluate the effect of bexagliflozin tablets on hemoglobin A1c in patients with type 2 diabetes mellitus and moderate renal impairment

Main objective of the trial: The primary objective of this study is to determine the efficacy of bexagliflozin on lowering HbA1c in patients with type 2 diabetes mellitus and moderate renal impairment. El objetivo principal de este estudio es determi...
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EU Clinical Trial 2015-003203-30 – EMA – Apr 15, 2016

Immunogenicity and Safety of the Purified Vero Rabies Vaccine- Serum Free (VRVg) in Comparison with the Human Diploid Cell Vaccine, IMOVAX® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy Children and Adolescents Aged 2 to 17 Years

Main objective of the trial: Immunogenicity - To demonstrate the VRVg is non-inferior to IMOVAX® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at Day 42, i.e. 1...
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EU Clinical Trial 2011-000826-31 – EMA – Aug 24, 2012

Safety, Efficacy and Pharmacokinetics of NNC-0156- 0000-0009 (N9-GP) in Previously Treated Children with Haemophilia B

Main objective of the trial: To evaluate immunogenicity of glycopegylated recombinant coagulation factor IX (NNC-0156- 0000-0009; hereafter referred to as N9-GP)
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EU Clinical Trial 2011-000391-34 – EMA – Oct 25, 2011

LUX-Head & Neck 1 A randomised, open-label, phase III study to evaluate the efficacy and safety of oral afatinib (BIBW 2992) versus intravenous methotrexate in patients with recurrent and/or metastatic head and neck squamous cell carcinoma who have progressed after platinum-based therapy

Main objective of the trial: To investigate the efficacy of afatinib versus methotrexate therapy in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy given f...
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EU Clinical Trial 2012-004366-18 – EMA – Jul 30, 2013

A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFα Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis

Main objective of the trial: To evaluate the PK of golimumab in pediatric subjects aged 2 through 17 years with moderately to severely active UC. To evaluate the safety of golimumab in pediatric subjects aged 2 through 17 years with moderately to sev...
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EU Clinical Trial 2006-006733-41 – EMA – Nov 30, 2007

Effet de l’association fixe amlodipine/valsartan sur la Pression artérielle centrale chez des hypertendus essentiels non contrôlés par amlodipine 5mg

Main objective of the trial: Comparer la baisse de pression artérielle systolique centrale entre V2 et V4 entre 2 groupes de patients présentant une HTA essentielle légère à modérée (140 mmHg ≥ PAS ≤ 179 mmHg et/ou 90mmHg ≥ PAD ≤ 109 mmHg et 130mmHg...
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EU Clinical Trial 2016-002782-57 – EMA – Nov 22, 2016

Phase 2 study of Brentuximab Vedotin associated with CHP followed by consolidation with high-dose therapy / autologous stem-cell transplantation as frontline treatment of patients with enteropathy-associated T-cell lymphoma type 1.

Main objective of the trial: To evaluate the 2-year progression-free survival (PFS). Evaluation de la survie sans progression à 2 ans
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EU Clinical Trial 2015-000107-94 – EMA – Mar 25, 2015

Etude ESPER : Epargne Sanguine au cours de la pose d’une Prothèse de hanche totale grâce à l’Exacyl® chez le patient traité par Rivaroxaban

Main objective of the trial: Evaluer l’impact de l’utilisation en post-opératoire de l’acide tranéxamique selon deux modes d’administration (standard ou prolongé) versus placebo sur les pertes sanguines dans la chirurgie prothétique de la hanche.
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EU Clinical Trial 2009-010360-41 – EMA – Jun 3, 2009

A multicentre, randomised, open-label, active-controlled trial of the effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in France

Main objective of the trial: The primary objective of this trial is to establish the effectiveness of buprenorphine/naloxone in reducing intravenous misuse of buprenorphine in opioid-dependent patients receiving buprenorphine maintenance therapy in F...
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EU Clinical Trial 2012-002945-40 – EMA – Sep 22, 2014

Efficacy, safety and immunogenicity of BI 695501 versus adalimumab in patients with active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial

Main objective of the trial: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active RA based on a statistical comparison of the proportion of patients meeting A...
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EU Clinical Trial 2014-005569-58 – EMA – Sep 23, 2015

An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of Rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures

Main objective of the trial: To evaluate whether rivaroxaban added to acetylsalicylic acid (ASA) is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as myocardial infarction (MI), ischemic stroke, cardiovascular...
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EU Clinical Trial 2012-004359-35 – EMA – Jan 1, 2012

An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old.

Main objective of the trial: Efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic medication (morphine equivalents in mg/kg body weight) used within the first 24 hours after first IMP intake.
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