9 results
Primary:To assess whether the addition of dronedarone (Multaq®) to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high HR at rest during AF in comparison to an increase of conventional…
The primary objective of this trial is to demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular…
To demonstrate that dronedarone is superior to amiodarone in the maintenance of sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.
PrimaryThe primary objective of the study is to evaluate the rate of AF recurrences one month after randomization according to different timings of initiation of dronedaroSecondaryThe secondary efficacy objective is to evaluate the rate of AF…
Part 1 Single Ascending Dose (SAD)- To evaluate the safety and tolerability of a single oral dose of prodrug, ABX-002, in healthy adult subjectsPart 2 Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of once daily oral doses of…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
To study the renal safety when HIV patients with TDF related renal toxicity switch to TAF compared to the current practice of switching to ABC.
Primary objectives:- To assess the relative bioavailability of TAF and TFV after a single-dose FTC/TAF 3x60/7.5 mg DT (reference TAF) compared to TAF and TFV after a single-dose FTC/TAF 3x 60/7.5mg DT in combination with a single dose of DTG 30mg as…