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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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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Study of Aripiprazole in Patients With Bipolar I Disorder The purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar I patients with manic or mixed episodes.

• Pays Australia, Bulgaria, Czech Republic, Estonia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russian Federation, South Africa, Spain, Switzerland, United Kingdom, United States,
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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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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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The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

• Pays Austria, Belgium, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Portugal, Serbia, South Africa, Spain, Sweden, United Kingdom,
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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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