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CLINICAL TRIALS PROFILE FOR SELEXIPAG
Clinical Trials for Selexipag
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01106014 | 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 ACT-293987 on time to first morbidity or mortality event in patients with pulmonary arterial hypertension. |
| NCT01112306 | ACT-293987 in Pulmonary Arterial Hypertension | Active, not recruiting | Actelion | Phase 3 | 2009-12-01 | Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON) |
| NCT02206204 | 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. |
| NCT02206295 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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