Kusajili – Centralise les essais cliniques mondiaux

Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that did not receive palivizumab

• Pays Austria, Belgium, France, Germany, Italy, Norway, Poland, Slovenia, Spain, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH) This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

• Pays Austria, Belgium, France, Germany, Hungary, Italy, Poland, United Kingdom,
• Organes Aucun
• Spécialités Aucun

A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

• Pays Austria, Belgium, Bulgaria, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, United Kingdom,
• Organes Aucun
• Spécialités Aucun

3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.

• Pays Belgium, Canada, France, Germany, Poland, Russian Federation, United States,
• Organes Aucun
• Spécialités Aucun

A Long-term Safety Study of Infliximab (Remicade) This is a study evaluating the long-term safety of infliximab (Remicade)

• Pays Argentina, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

• Pays Belgium, Canada, Czech Republic, Estonia, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Spain, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

Non-Interventional Retrospective Correlation Of Tumor Mutational Status To Clinical Benefit Of GIST Patients Treated With Sunitinib Retrospective correlation of clinical outcomes data with mutational status in GIST subjects treated with sunitinib.

• Pays Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Korea, Republic of, Netherlands, Poland, Slovakia, Spain, Switzerland, United Kingdom, United States,
• 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

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,
• Organes Aucun
• Spécialités Aucun

Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.

• Pays Belgium, France, Germany, Hungary, India, Italy, Poland, Turkey, United States,
• Organes Aucun
• Spécialités Aucun