Kusajili – Centralise les essais cliniques mondiaux

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

• Pays Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland,
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A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

• Pays Argentina, Bulgaria, Croatia, Czech Republic, Finland, France, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa,
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A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in subjects with active psoriatic arthritis (PsA) who are inadequately responding to methotrexate (MTX) treatment.

• Pays Australia, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Latvia, New Zealand, Poland, Romania, Spain, United States,
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Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

• Pays Canada, Denmark, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom,
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Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

• Pays Australia, Belgium, Canada, Chile, Czech Republic, France, Italy, Mexico, Netherlands, Poland, Portugal, Spain, United Kingdom,
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Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease

• Pays Belgium, Canada, Czech Republic, France, Netherlands, Poland, United Kingdom, United States,
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Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH), to patients suffering from inoperable chronic thromboembolic pulmonary hypertension (CTEPH) because of (i) peripheral localization of thrombotic material or (ii) persistent or recurrent pulmonary hypertension after pulmonary endarterectomy.

• Pays Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom, United States,
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A Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

• Pays Czech Republic, France, Hungary, Israel, Italy, Poland, Spain, United Kingdom,
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Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

• Pays Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom, United States,
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Diabetes Attitudes Wishes and Needs The study is conducted in Africa, Asia, Europe, Japan, North America and South America. The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.

• Pays Algeria, Canada, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, Spain, Turkey, United Kingdom, United States,
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