Kusajili – Centralise les essais cliniques mondiaux

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

• Pays Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland,
• Organes Aucun
• Spécialités Aucun

Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study The AC-055B201/MUSIC study is a Phase II study, comparing one dose of ACT-064922 (macitentan) 10 mg with placebo in patients with idiopathic pulmonary fibrosis (IPF). The main study objective is to demonstrate that macitentan positively affects the forced vital capacity (FVC) in comparison with placebo in patients with idiopathic pulmonary fibrosis (IPF). The secondary objectives are to evaluate the effect of macitentan on the time to disease worsening or death in patients with IPF, and to evaluate the benefit/risk profile of macitentan in the treatment of patients with IPF.

• Pays Australia, Canada, France, Germany, Israel, Italy, Slovenia, South Africa, Spain, Sweden, Turkey, United States,
• Organes Aucun
• Spécialités Aucun

Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.

• Pays Belgium, Denmark, France, Italy, Netherlands, Spain, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

• Pays Argentina, Belgium, Canada, Colombia, Denmark, France, Germany, Italy, Korea, Republic of, Netherlands, South Africa, Spain, Switzerland, Turkey, United States,
• Organes Aucun
• Spécialités Aucun

A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response to Methotrexate This study is a Phase 2 randomized, double-blind, double-dummy, active- and placebo-controlled, parallel-group study designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of multiple doses of ABT-122 in subjects with active psoriatic arthritis (PsA) who are inadequately responding to methotrexate (MTX) treatment.

• Pays Australia, Bulgaria, Czech Republic, France, Germany, Hungary, Italy, Latvia, New Zealand, Poland, Romania, Spain, United States,
• Organes Aucun
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Study of Safety in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Eculizumab The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

• Pays Australia, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun

An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.

• Pays Belgium, Canada, Finland, France, Italy, Sweden, Turkey,
• Organes Aucun
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Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

• Pays Canada, Denmark, France, Germany, Italy, Poland, Russian Federation, Spain, Sweden, Switzerland, Turkey, United Kingdom,
• Organes Aucun
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Evaluation of SR 31747A Versus Placebo in Androgen-Independent Non Metastatic Prostate Cancer To evaluate the efficacy of SR31747 given at 75 or 125mg per day versus placebo in androgen prostate cancer patient without distant metastases with Time to Clinical progression as main objective and PSA parameters, Tumor response, survival , safety,Tumor-related symptoms deterioration Quality of Life, PK analysis as secondary objectives

• Pays Australia, Belgium, Canada, Chile, Czech Republic, France, Italy, Mexico, Netherlands, Poland, Portugal, Spain, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Bosentan in Digital Ulcers The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

• Pays Austria, Canada, France, Germany, Italy, Switzerland, United Kingdom, United States,
• Organes Aucun
• Spécialités Aucun