Kusajili – Centralise les essais cliniques mondiaux

A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.

• Pays Argentina, Bulgaria, Croatia, Czech Republic, Finland, France, Mexico, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa,
• Organes Aucun
• Spécialités Aucun

Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.

• Pays Bulgaria, Croatia, Czech Republic, France, Germany, Hungary, India, Italy, Philippines, Poland, Portugal, Serbia, Slovakia, South Africa, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Lurasidone Extended Use Study This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

• Pays Canada, Colombia, Czech Republic, France, India, Lithuania, Romania, Russian Federation, Serbia, Slovakia, South Africa, Ukraine,
• Organes Aucun
• Spécialités Aucun

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,
• Organes Aucun
• Spécialités Aucun

FUTURE 3 Study Extension The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).

• Pays Australia, Belarus, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun

Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.

• Pays Australia, Belarus, China, Czech Republic, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun