Kusajili – Clinical trials directory

BUILD 3: Bosentan Use in Interstitial Lung Disease BUILD 3 is a prospective, multicenter, randomized, double-blind, parallel group, placebo-controlled, event-driven, group sequential, phase III superiority study. The primary objective is to demonstrate that bosentan delays disease worsening or death in patients with Idiopathic Pulmonary Fibrosis.

• Country Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Serbia, Spain, Switzerland, United Kingdom, United States,
• organs None
• Specialty None

Satavaptan Dose-Ranging Study in Normonatraemic Patients With Cirrhotic Ascites The primary objective is to determine the optimal dose or range of doses of SR121463B for the treatment of ascites when used concomitantly with a standard dose regimen of spironolactone and furosemide. The secondary objective is to determine the tolerability of different fixed doses of SR121463B over a 14 day treatment period in cirrhotic ascites.

• Country Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Romania, Spain,
• organs None
• Specialty None

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.

• Country 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,
• organs None
• Specialty None

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.

• Country Bulgaria, Croatia, Czech Republic, France, Germany, Hungary, India, Italy, Philippines, Poland, Portugal, Serbia, Slovakia, South Africa, United Kingdom,
• organs None
• Specialty None

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.

• Country 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,
• organs None
• Specialty None

Satavaptan Dose-Ranging Study in the Prevention of Ascites The primary objective is to determine the optimal dose or range of doses of SR121463B for the reduction in recurrence of ascites, when used concomitantly with a standard dose regimen of spironolactone. The secondary objective was to determine the tolerability of different fixed doses of SR121463B in cirrhotic ascites, over a 12-week treatment period. This SPA study is followed by a single-blind, placebo-controlled, 40 weeks long-term safety extension (ExSPA). The first extension is followed by another long-term study (PASCCAL-1).

• Country Argentina, Australia, Belgium, Canada, Croatia, Czech Republic, France, Germany, Italy, Spain, Taiwan, Province of China,
• organs None
• Specialty None

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.

• Country 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,
• organs None
• Specialty None

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

• Country Australia, Austria, Croatia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom,
• organs None
• Specialty None