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
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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 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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Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

• Pays Belgium, Croatia, Czech Republic, Finland, France, Hungary, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Ukraine, United Kingdom,
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An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic Parkinson's disease

• Pays Australia, Austria, Croatia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom,
• Organes Aucun
• Spécialités Aucun