The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension
Completed
Actelion
Phase 3
2016-05-01
The objective of this clinical trial is to compare the efficacy and safety of an initial
triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral
treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve
patients with pulmonary arterial hypertension.
Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)
Terminated
Actelion
Phase 4
2015-09-01
The purpose of the study is to document the effect of first line dual oral combination
therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in
treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects
Completed
Actelion
Phase 1
2017-08-07
The primary objective of this study is to demonstrate that macitentan and tadalafil
administered as a fixed combination is bioequivalent to both compounds given as separate
tablets given at the same doses as in the fixed combination (i.e. whether the amounts of
macitentan and tadalfil which reach the blood are comparable).
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