8 results
The primary objective of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with PAH. This will be assessed by time…
The primary objective is to test the hypothesis that once daily tadalafil administered orally for 48 weeks lessens the decline in ambulatory ability as measured by the 6MWD compared to placebo in boys with Duchenne muscular dystrophy (DMD). Two…
Primary Objectives:* For the European Union (EU) regulatory assessment, the primary objective of Period 1 is to evaluate theefficacy of tadalafil compared with placebo, as measured by time to clinical worsening (CW) in pediatricPAH patients through…
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
Primary ObjectivesThe primary objectives of this study are as follows:• To evaluate the safety and tolerability of risdiplam.• To investigate the pharmacokinetics (PK) of risdiplam and metabolites as appropriate.Secondary ObjectiveThe secondary…
* Evaluate the safety of ME-APDS in subjects during colonoscopy.* Assess the efficacy of ME-APDS - whether the use of the ME-APDS improves the Adenoma Per Colonoscopy APC when compared to conventional colonoscopy (CC). Thereby we aim to further…
The central question of this study is *What is the effect of supplementation of regular therapy with 8 weeks of HR after a first, acute, proximal DVT of the lower extremity on objective aspects of thrombus resolution which are associated with the…
The primary objective is to assess the proportion of patients in each treatment arm with a satisfactory clinical response as defined by a composite primary endpoint at Week 24.The secondary objective is to demonstrate safety and clinical effect at…