Kusajili – Centralise les essais cliniques mondiaux

Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

• Pays Argentina, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Malaysia, Portugal, Romania, Serbia, Singapore, South Africa, Spain, Taiwan, Province of China, 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,
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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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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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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,
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A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg Plus 250mg Loading Regimen and 500mg This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.

• Pays Belgium, Canada, Czech Republic, France, Hungary, Poland, Romania, Turkey,
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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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A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with unresectable pancreatic neuroendocrine tumors.

• Pays Australia, Belgium, China, Czech Republic, France, Hungary, India, Italy, Japan, Norway, Romania, Slovakia, 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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