Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
Completed
Actelion
Phase 3
2009-12-01
The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of
selexipag on time to first morbidity or mortality event in patients with pulmonary arterial
hypertension.
Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
Completed
Actelion
Phase 1
2012-06-01
This is a single-center, double-blind, randomized, placebo- and positive-controlled,
double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over
comparison between moxifloxacin and placebo in healthy male and female subjects. The primary
objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an
effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally
administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects.
Moxifloxacin is included as a positive control.
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
Completed
Actelion
Phase 1
2012-09-01
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of
absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of
1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8
film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a
multiple-dose up-titration scheme.
Effects of Selexipag in Adults With Raynaud's Phenomenon Secondary to Systemic Sclerosis
Completed
Actelion
Phase 2
2014-10-01
The primary objective of the study is to determine the activity of selexipag on Raynaud
attack frequency in subjects with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis
(SSc).
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