Kusajili – Centralise les essais cliniques mondiaux

Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation Primary Objective: - Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone. Secondary Objective: - Evaluate the rate of AF recurrences two months after randomization. - Assess the safety of the change from amiodarone to dronedarone - Assess dronedarone safety - Explore dronedarone and its active metabolite plasma level (in a subset of countries) - Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)

• Pays Australia, Austria, Estonia, Finland, France, Germany, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Spain, Switzerland, Taiwan, Province of China, United Kingdom,
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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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Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

• Pays Canada, Denmark, Finland, France, Germany, Italy, Poland, Portugal, Spain, Switzerland, United Kingdom,
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Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).

• Pays Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, New Zealand, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom,
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A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

• Pays Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom,
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Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.

• Pays Austria, Croatia, Czech Republic, Finland, France, Greece, Hungary, India, Ireland, Italy, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Taiwan, Province of China, Thailand, United Kingdom, United States,
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A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

• Pays Australia, Belgium, Colombia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland,
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Dose Ranging Study of Celivarone With Amiodarone as Calibrator for the Prevention of Implantable Cardioverter Defibrillator (ICD) Interventions or Death The Primary objective was to assess the efficacy of Celivarone for the prevention of Implantable Cardioverter Defibrillator (ICD) interventions or death. Secondary objectives were: - To assess the tolerability and safety of the different dose regimens of Celivarone in the selected population. - To document Celivarone plasma levels during the study.

• Pays Argentina, Australia, Belgium, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, United States,
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Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy Primary Objective: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in Glycated Hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled Month 6) in adult participants with type 2 diabetes mellitus Secondary Objective: - To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal hypoglycemia

• Pays Canada, Chile, Finland, France, Germany, Hungary, Mexico, Portugal, Romania, Russian Federation, South Africa, Spain, United States,
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Crestor Versus Placebo in Subjects With Heart Failure The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)

• Pays Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, United Kingdom,
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