7 results
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…
We want to demonstrate or exclude through this study that the administration of a dilute anesthetic solution, using local tumescent anesthesia technique, will lead to a significant decrease in per-and postoperative pain in patients undergoing…
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…
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…
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…
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…
The primary objective of this study is to determine the safety and feasibility of turbine-based insufflation, measured in terms of occurrence of adverse device effects and serious adverse device effects. The secondary objectives are to determine the…