Kusajili – Centralise les essais cliniques mondiaux

Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

• Pays Czech Republic, Denmark, Finland, France, Hungary, Norway, Sweden,
• Organes Aucun
• Spécialités Aucun

Efficacy of Pioglitazone on Macrovascular Outcome in Patients With Type 2 Diabetes The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

• Pays Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, United Kingdom,
• 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,
• 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

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
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Dose-finding Study With Lu AA24530 in Major Depressive Disorder The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

• Pays Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, India, Korea, Republic of, Lithuania, Malaysia, Norway, Philippines, Russian Federation, Serbia, Sweden, Ukraine,
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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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12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

• Pays Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Lebanon, Netherlands, Norway, Sweden, United States,
• Organes Aucun
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Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

• Pays Austria, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Latvia, Lithuania, Norway, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Province of China, Ukraine, United States,
• Organes Aucun
• Spécialités Aucun