Kusajili – Centralise les essais cliniques mondiaux

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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Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

• Pays Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain,
• Organes Aucun
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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

• Pays Australia, Belgium, Canada, Denmark, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom, United States,
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To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.

• Pays Australia, Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden, United Kingdom,
• Organes Aucun
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Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention. Two hypothesis will be tested: 1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy 2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.

• Pays Denmark, France, Greece, Hungary, Italy, Netherlands, Romania, Slovenia, Spain, Sweden, Turkey,
• Organes Aucun
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Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

• Pays Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain,
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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

• Pays Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom,
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CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability. As this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.

• Pays Croatia, France, Hungary, Jordan, Kazakhstan, Lebanon, Macedonia, the former Yugoslav Republic of, Moldova, Republic of, Romania, Russian Federation, Ukraine,
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Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.

• Pays Austria, Belgium, Bulgaria, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Russian Federation, Slovenia, Spain, Switzerland, Turkey, United Kingdom,
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Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

• Pays Argentina, Australia, Belgium, Canada, Colombia, Egypt, Finland, France, Germany, Guatemala, Hungary, Iceland, India, Italy, Korea, Republic of, Philippines, Poland, Romania, Singapore, Spain, Sweden, United Kingdom, United States,
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