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,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
• Spécialités Aucun

Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis This study is an extension to the study AC-058B201 and will investigate the long-term safety, tolerability and efficacy of ponesimod in patients with relapsing-remitting multiple sclerosis.

• Pays Austria, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

• Pays Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Slovakia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
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Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

• Pays Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden,
• Organes Aucun
• Spécialités Aucun

A Study of Tasisulam Versus Paclitaxel as Treatment for Metastatic Melanoma The primary purpose of this study is to see how tasisulam affects metastatic melanoma when compared against paclitaxel as measured by overall survival.

• Pays Australia, Austria, Belgium, Canada, Finland, France, Germany, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, Province of China, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of ACT-128800 in Patients With Relapsing-remitting Multiple Sclerosis This study will assess the efficacy, safety, and tolerability of ACT-128800 in patients with relapsing-remitting multiple sclerosis.

• Pays Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Romania, Russian Federation, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
• Spécialités Aucun