4 results
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
To evaluate the safety, tolerability and efficacy of 3 doses of vernakalant (oral) (150 mg, 300 mg and 500 mg b.i.d.) administered for up to 90 days in subjects with sustained symptomatic atrial fibrillation (AF duration > 72 hours and &…
The aim of this study is to investigate how quickly and to what extent aticaprant is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). For this study, aticaprant is radioactively labelled with carbon-14 (14C). In…
To evaluate the relative oral bioavailability and dose proportionality of concept formulations compared with the reference formulation of aticaprant when administered in healthy adult participants. This part will be conducted by PRA.To evaluate the…