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EU Clinical Trial 2010-021529-11 – EMA – Mar 10, 2011

A randomized, double-blind, placebo-controlled, multicenter Phase II trial investigating two doses of EMD 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

Main objective of the trial: The primary objective of the trial is to evaluate the clinical anti-tumor acitivity of EMD 525797 administered as 1-hour intravenous (i.v.) infusion every 3 weeks in terms of progression free survival (PFS) time in subjec...
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EU Clinical Trial 2008-006168-12 – EMA – Nov 17, 2008

Phase II trial with Cetuximab and Irinotecan (CetIri) for patients with platinum resistant esofagus- or gastric cancer

Main objective of the trial: The main objektives are responserate and time to progression
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EU Clinical Trial 2015-003190-14 – EMA – Apr 19, 2016

Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A vaccine) Administered 6 Months Apart in Healthy Toddlers, Children and Adolescents Aged 12 Months to 15 Years in China

Main objective of the trial: To describe the safety of Avaxim 80U Pediatric vaccine after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years.
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EU Clinical Trial 2010-024252-29 – EMA – Apr 1, 2011

A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

Main objective of the trial: The primary objective is to demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC). Demostrar la reducción del deterioro de la función pulmon...
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EU Clinical Trial 2011-000986-10 – EMA – Dec 14, 2011

A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, FLEXIBLE-DOSE, PARALLEL-GROUP STUDY OF LURASIDONE ADJUNCTIVE TO LITHIUM OR DIVALPROEX FOR THE PREVENTION OF RECURRENCE IN SUBJECTS WITH BIPOLAR I DISORDER

Main objective of the trial: To evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.
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EU Clinical Trial 2010-024133-23 – EMA – Oct 31, 2011

An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor RO5185426 in Patients with Metastatic or Unresectable Papillary Thyroid Cancer (PTC) positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

Main objective of the trial: To evaluate best overall response rate (BORR) (complete + partial response) in Cohort 1 (TKI-naïve patients). − BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic...
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EU Clinical Trial 2013-002096-18 – EMA – Aug 13, 2014

AN OPEN-LABEL, MULTI-CENTER, RANDOMIZED PHASE 1B/2 STUDY OF PF05212384 PLUS 5-FLUOROURACIL-LEUCOVORIN-IRINOTECAN (FOLFIRI) VERSUS BEVACIZUMAB PLUS FOLFIRI IN METASTATIC COLORECTAL CANCER

Main objective of the trial: Phase 1b -To assess safety and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of the combination of PF-05212384 plus FOLFIRI. Phase 2 -To demonstrate that the combination of PF-05212384...
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EU Clinical Trial 2012-001984-66 – EMA – Apr 25, 2013

A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients with Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment with Adalimumab and MTX

Main objective of the trial: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by...
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EU Clinical Trial 2011-003427-36 – EMA – Apr 12, 2012

Randomized, Double-Blind, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Metastatic or Advanced Non-Small-Cell Lung Cancer (NSCLC)

Main objective of the trial: To assess if the addition of oral veliparib to carboplatin and paclitaxel compared to carboplatin and paclitaxel alone in subjects with metastatic or advanced NSCLC will improve progression-free survival (PFS).
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EU Clinical Trial 2007-003780-50 – EMA – Jul 30, 2008

Estudio de fase 3, abierto y aleatorizado, de bosutinib comparado con imatinib en sujetos con leucemia mieloide crónica cromosoma Filadelfia positiva en fase crónica, de diagnóstico reciente A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Main objective of the trial: Compare the rate of complete cytogenetic response (CCyR) at one year in chronic phase subjects receiving bosutinib alone versus chronic phase subjects receiving imatinib alone.
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EU Clinical Trial 2013-004795-35 – EMA – Jun 2, 2014

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

Main objective of the trial: To compare the efficacy of CMX001 to placebo for the prevention of clinically significant CMV infection in R+ allogeneic hematopoietic stem cell transplant (HSCT) recipients To compare the safety and tolerability of CMX00...
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EU Clinical Trial 2010-021870-12 – EMA – Feb 15, 2011

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer

Main objective of the trial: The primary objective of this study is to confirm the effect of tasquinimod on delaying disease progression or death compared with placebo.
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EU Clinical Trial 2011-005219-98 – EMA – Oct 8, 2012

Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax™ Treatment (PRESENT)

Main objective of the trial: The primary objective is to compare the disease-free survival (DFS) in subjects with early-stage, operable node-positive breast cancer with low and intermediate HER2 expression who receive standard of care multimodality t...
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EU Clinical Trial 2009-015507-52 – EMA – Nov 13, 2009

A multicenter, randomized, double-blind, placebo controlled phase III study of panobinostat in combination with bortezomib and dexamethasone in patients with relapsed multiple myeloma.

Main objective of the trial: To compare progression-free survival (PFS), in patients treated with PAN in combination with BTZ/Dex vs. patients treated with placebo in combination with BTZ/Dex.
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EU Clinical Trial 2009-013618-29 – EMA – Aug 17, 2010

Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years.

Main objective of the trial: This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE. The study will also...
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EU Clinical Trial 2012-000327-40 – EMA – May 27, 2013

A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Escalation Study to Select and Evaluate an Oral Modified Release Formulation of Omecamtiv Mecarbil in Subjects with Heart Failure and Left Ventricular Systolic Dysfunction

Main objective of the trial: (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in subjects with HF and left ventricular systolic dysfunction and (ii) to characterize its pharma...
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EU Clinical Trial 2011-004943-32 – EMA – Dec 13, 2011

ICORG 11-24-NSABP PROTOCOL B-47 A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

Main objective of the trial: To determine whether the addition of trastuzumab to chemotherapy (TC or AC-WP) improves invasive disease-free survival (IDFS) in women with resected node-positive or high-risk node-negative breast cancer which is reported...
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EU Clinical Trial 2010-020140-36 – EMA – Sep 13, 2010

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo- Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo, de fase III, de eficacia y seguridad en 3 grupos de dosis fija de TC-5214 (S-mecamilamina) como complemento de un antidepresivo en pacientes con trastorno depresivo mayor que presentan una respuesta insuficiente al tratamiento antidepresivo

Main objective of the trial: * Evaluar la eficacia de TC-5214 en comparación con placebo como complemento del tratamiento antidepresivo (inhibidor selectivo de la recaptación de serotonina [ISRS]/inhibidor de la recaptación de serotonina/noradrenalin...
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EU Clinical Trial 2009-016163-12 – EMA – Jul 2, 2010

A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Psoriasis.

Main objective of the trial: To evaluate the safety of long-term exposure with AMG 827 in subjects with moderate to severe psoriasis. To evaluate the efficacy of AMG 827 as measured by the following: − The proportion of subjects with a static physici...
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EU Clinical Trial 2012-000781-38 – EMA – Oct 8, 2012

Prospective, Randomized, open label, European, multicenter study of the efficacy of the linezolid-rifampin combination versus standard of care in the treatment of Gram-positive prosthetic hip joint infection

Main objective of the trial: The main objective is to evaluate the efficacy of oral linezolid-rifampin combination therapy (over 4 or 6 weeks) versus standard of care therapy in the treatment of Gram-positive prosthetic Hip joint infection with one-s...
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EU Clinical Trial 2011-003574-84 – EMA – Jan 31, 2012

A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC).

Main objective of the trial: To evaluate efficacy of GC33 vs. placebo through investigator-assessed progression-free survival (PFS) in patients with unresectable advanced or metastatic hepatocellular carcinoma (HCC) previously treated with at least 1...
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EU Clinical Trial 2014-000316-34 – EMA – Mar 12, 2015

A phase I/II multicenter, open-label study of CLR457 administered orally in adult patients with advanced solid malignancies

Main objective of the trial: 1. To estimate the MTD or RP2D of CLR457 (dose escalation phase) 2. To investigate the anti-tumor activity of CLR457 (Phase II) 1. Valutare la MTD o la RP2D di CLR457 (fase di incremento della dose) 2. Valutare l’attività...
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EU Clinical Trial 2010-022802-41 – EMA – Feb 25, 2011

SAFETY AND PHARMACOKINETICS OF ODM-201 IN PATIENTS WITH CASTRATE RESISTANT PROSTATE CANCER: OPEN, NON-RANDOMISED, UNCONTROLLED, MULTICENTRE, MULTIPLE DOSE ESCALATION STUDY WITH A RANDOMISED PHASE II EXPANSION COMPONENT

Main objective of the trial: To evaluate safety and tolerability of ODM-201 and to define dose(s) of ODM-201 for further clinical studies. Dose-limiting toxicities (DLT) and the MTD and/or OTD will be determined.
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EU Clinical Trial 2012-002847-28 – EMA – Apr 11, 2013

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 18-Month Safety and Efficacy Study of Leuco-methylthioninium bis(hydromethanesulfonate) in Subjects with Mild Alzheimer’s Disease

Main objective of the trial: 1. To demonstrate the clinical efficacy of leuco-methylthioninium bis(hydromethanesulfonate) (also known as LMTM, TRx0237) in mild Alzheimer's disease based on change from baseline on the following coprimary endpoints: •...
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EU Clinical Trial 2016-001248-20 – EMA – Jul 20, 2016

Impact of new generation hormono-therapy on cognitive functions in elderly patients treated for a metastatic prostate cancer

Main objective of the trial: To evaluate the incidence of cognitive dysfunctions and cognitive complaints among elderly men after 3 months of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer (CRPCa)...
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EU Clinical Trial 2014-004655-31 – EMA – Mar 25, 2015

Preoperative window-of-opportunity (WoO) study of Debio 1143 with or without cisplatin (CDDP) in patients with resectable squamous cell carcinoma of the head and neck.

Main objective of the trial: To investigate the pharmacodynamic activity of Debio 1143, alone or in combination with cisplatin, in patients with squamous cell carcinoma of the head and neck
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EU Clinical Trial 2011-001754-28 – EMA – Jun 5, 2012

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTRE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 FOR MAINTENANCE THERAPY IN SUBJECTS WITH MODERATE TO SEVERE CROHN?S DISEASE

Main objective of the trial: The primary objective of the study is to estimate the effects of CP-690,550 in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn?s disease previously achieving clinical respon...
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EU Clinical Trial 2014-001132-10 – EMA – Oct 23, 2014

A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias

Main objective of the trial: Demonstrate the efficacy of Amantadine Extended Release (ER) Tablets versus placebo on the Unified Dyskinesia Rating Scale (UDysRS) in patients with Levodopa-Induced Dyskinesia (LID) after 12 weeks of treatment at a fixed...
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EU Clinical Trial 2010-020380-20 – EMA – Mar 9, 2012

Open-Label Evaluation of the Pharmacokinetic Profile and Safety of Tapentadol Oral Solution for the Treatment of Postsurgical Pain in Children and Adolescents Aged From 6 to Less Than 18 Years

Main objective of the trial: To evaluate the pharmacokinetic profile of Tapentadol and its major metabolite Tapentadol-O-glucuronide after administration of a single dose of Tapentadol oral solution (OS) 1 mg/kg in children and adolescents aged from...
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EU Clinical Trial 2011-000493-56 – EMA – Sep 15, 2011

A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF GDC-0980 VERSUS EVEROLIMUS IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WHO HAVE PROGRESSED ON OR FOLLOWING VEGF-TARGETED THERAPY

Main objective of the trial: ?To evaluate the efficacy of GDC-0980 versus everolimus as measured by progression-free survival (PFS) defined as the time from randomization to disease progression ? Evaluar la eficacia de GDC-0980 frente a everolimus, q...
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EU Clinical Trial 2007-006393-29 – EMA – Apr 15, 2008

A 4-week double-blind placebo-controlled pilot study, evaluating niacin-induced flushing and lipid parameter effects of V0002 CA 1g 3 capsules/day associated with Niaspan® (from 375 mg to 1000 mg) in addition to usual care statin, in patients suffering from dyslipidemia with uncontrolled elevated triglycerides.

Main objective of the trial: To assess efficacy of V0002 CA 1 g at 3 capsules /day on preventing niacin-induced flushing promoted by Niaspan® administration
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EU Clinical Trial 2009-011739-11 – EMA – Aug 4, 2009

Phase 2 Study of Pemetrexed and Cisplatin as Induction, Followed by Pemetrexed and Cisplatin with Concurrent Thoracic Radiotherapy, in Patients with Unresectable Locally-Advanced Stage III, Non-Squamous, Non-Small Cell Lung Cancer

Main objective of the trial: Progression free survival at 1 year
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EU Clinical Trial 2009-017432-40 – EMA – Apr 13, 2010

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-Center Clinical Study to Evaluate Efficacy and Safety of a Maintenance Therapy with Immunomodulator MGN1703 in Patients with Advanced Colorectal Carcinoma with Disease Control after Initial First-line Therapy (IMPACT Study)

Main objective of the trial: The primary objective of this study is to demonstrate that the efficacy variables of MGN1703 in the maintenance treatment of patients with advanced colorectal carcinoma with disease control after initial first-line therap...
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EU Clinical Trial 2015-001879-43 – EMA – Mar 11, 2016

A Phase 1b/2, Open-Label, Dose-Finding Study to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Avelumab (MSB0010718C) in Combination with Either Crizotinib or PF-06463922 in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

Main objective of the trial: Phase 1b Primary Objective: - Group A (ALK-negative): To determine MTD and the recommended Phase 2 dose (RP2D) of the combination of avelumab with crizotinib. - Group B (ALK-positive): To determine the MTD and the RP2D of...
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EU Clinical Trial 2011-005535-68 – EMA – May 8, 2012

A randomized, double-blind, placebo controlled study to assess efficacy, safety and tolerability of LCQ908 in subjects with Familial Chylomicronemia Syndrome

Main objective of the trial: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study w...
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EU Clinical Trial 2004-004891-36 – EMA – Apr 1, 2005

CROSS-OVER COMPARISON OF TESTOSTERONE SERUM LEVELS IN HYPOGONADAL MEN TREATED WITH L0074 TESTOSTERONE PATCH 60CM2 (2 patches/48H) AND ORAL TESTOSTERONE UNDECANOATE -PANTESTONE® 40mg- (2 caps, bid)

Main objective of the trial: To compare mean serum total testosterone levels over the last 48 hrs of a 22-day treatment with L0074 TD versus Pantestone®.
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EU Clinical Trial 2012-003280-22 – EMA – Aug 13, 2013

Phase 3 open label study evaluating the efficacy and safety of pegylated interferon lambda-1a, in combination with ribavirin and daclatasvir, for treatment of chronic HCV infection with treatment naïve genotypes 1, 2, 3 or 4 in subjects co-infected with HIV. Revised Protocol 01 - Incorporates Administrative Letter 01 and Amendment 02 + Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 15-Apr-2013)

Main objective of the trial: To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12) following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1.
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EU Clinical Trial 2010-022029-13 – EMA – Aug 11, 2011

A single-arm, open-label, phase 2 clinical trial evaluating disease response following treatment with intravenous BHQ880, a fully human, anti-Dickkopf1 (DKK1) neutralizing antibody in previously untreated patients with high-risk, smoldering multiple myeloma

Main objective of the trial: Assess the overall response rate after BHQ880 treatment in previously untreated patients with high-risk SMM
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EU Clinical Trial 2010-019843-20 – EMA – Jan 1, 2010

A Prospective 3-Year Follow-up Study in Subjects Previously Treated in a Phase IIb or Phase III Study With a TMC435-Containing Regimen for the Treatment of Hepatitis C Virus (HCV) infection

Main objective of the trial: - To evaluate the durability of sustained virologic response (SVR) in subjects who were treated with a TMC435- containing regimen in a previous Phase IIb or Phase III study and maintained undetectable HCV ribonucleic acid...
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EU Clinical Trial 2012-001461-32 – EMA – Jul 12, 2012

A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer

Main objective of the trial: To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm
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EU Clinical Trial 2007-003905-28 – EMA – Oct 8, 2007

Etude randomisée, en groupes parallèles, en double insu, de l’efficacité de la méquitazine sur la symptomatologie et l’obstruction nasale chez des patients présentant une rhinite allergique perannuelle

Main objective of the trial: évaluer l’efficacité de la méquitazine sur la symptomatologie nasale (rhinorrhée, prurit nasal, obstruction nasale, éternuement).
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EU Clinical Trial 2004-000755-41 – EMA – Sep 22, 2004

A three-month, double-blind, double dummy, parallel group, controlled study comparing the efficacy and safety between 12 µg twice daily of Formoterol-HFA and 12 µg twice daily of Formoterol-DPI (Foradil/Aerolizer) in children with persistent asthma

Main objective of the trial: To compare the efficacy and safety of 12 µg of formoterol-HFA b.i.d versus 12 µg of formoterol-DPI b.i.d over a 12-week treatment period in asthmatic children 5 to 12 years old with persistent asthma requiring regular inh...
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EU Clinical Trial 2013-002618-10 – EMA – Feb 18, 2014

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication

Main objective of the trial: The primary objectives are to evaluate the safety and efficacy of 2 fixed doses of EVP-6124 (2 or 3 mg daily) compared to placebo for 26 weeks in subjects with mild to moderate dementia due to AD currently receiving stabl...
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EU Clinical Trial 2009-014563-39 – EMA – Mar 2, 2010

Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator`s choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment

Main objective of the trial: To investigate the efficacy of BIBW 2992 plus weekly paclitaxel versus Investigator`s choice chemotherapy in patients with Stage IIIb or IV non-small cell lung cancer (NSCLC) experiencing a benefit from BIBW 2992 monother...
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EU Clinical Trial 2011-004763-72 – EMA – Jun 26, 2012

A Phase IIb, Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Dose-Ranging Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-945429 in Subjects with Moderate to Severe Crohn's Disease Revised Protocol 01, incorporating Amendment 02 (dated 20-Mar-12) + Pharmacogenetics Blood Sample Amendment 01

Main objective of the trial: The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn’s disease and who have had an insufficient response to conventional therapy or ha...
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EU Clinical Trial 2007-006029-29 – EMA – Feb 7, 2008

Etude de l'efficacité de CIRKALM crème versus placebo dans le traitement des douleurs anales

Main objective of the trial: Etudier l'évolution de la douleur anale sur les quatorze premiers jours de traitement (douleur journalière moyenne ressentie).
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EU Clinical Trial 2006-006487-32 – EMA – Feb 27, 2007

CLINICAL EFFICACY EVALUATION OF A FIXED COMBINATION OF CALCITRIOL 3 µg/g WITH THREE CONCENTRATIONS (100, 250, 500µg/g) OF CLOBETASOL PROPIONATE AS SPRAY FORMULATION USING THE MODIFIED DUMAS-SCHOLTZ PSORIASIS MINI PLAQUE TEST UNDER NON-OCCLUSIVE CONDITIONS

Main objective of the trial: To evaluate the clinical efficacy of a fixed combination of calcitriol 3µg/g with three concentrations (100µg/g, 250µg/g, 500µg/g) of clobetasol, by evaluation of their clinical efficacy in comparison to: • The same conce...
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EU Clinical Trial 2006-006299-39 – EMA – Apr 23, 2008

A Placebo-Controlled, Randomized, Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Neurogenic Detrusor Overactivity and Neurological Respiratory Impairment

Main objective of the trial: To evaluate the safety and efficacy of 2 dose levels of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patien...
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EU Clinical Trial 2012-001455-39 – EMA – Oct 10, 2012

A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Main objective of the trial: • Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A. • Part A: To select the...
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EU Clinical Trial 2008-008394-63 – EMA – Oct 26, 2009

A 52-week treatment, randomized, double-blind, placebo-controlled, with open label tiotropium, parallel-group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease

Main objective of the trial: To confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs placebo significantly increases mean 24 h post-dose (trough) FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2008)
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