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CLINICAL TRIALS PROFILE FOR SELEXIPAG

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Clinical Trials for Selexipag

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01106014	Selexipag (ACT-293987) in Pulmonary Arterial Hypertension	Completed	Actelion	Phase 3	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	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	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	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.

Clinical Trial Conditions for Selexipag

Condition Name

Condition Name for Selexipag
Intervention	Trials
Pulmonary Arterial Hypertension	7
Healthy Subjects	5
Pharmacokinetics	1
Chronic Thromboembolic Pulmonary Hypertension	1

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Condition MeSH

Condition MeSH for Selexipag
Intervention	Trials
Hypertension	8
Familial Primary Pulmonary Hypertension	7
Hypertension, Pulmonary	1
Sclerosis	1

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Clinical Trial Locations for Selexipag

Trials by Country

Trials by Country for Selexipag
Location	Trials
United States	63
Canada	13
Australia	12
Germany	8
France	6

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Trials by US State

Trials by US State for Selexipag
Location	Trials
California	4
Pennsylvania	4
Michigan	4
Kentucky	4
Georgia	4

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Clinical Trial Progress for Selexipag

Clinical Trial Phase

Clinical Trial Phase for Selexipag
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2	2

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Clinical Trial Status

Clinical Trial Status for Selexipag
Clinical Trial Phase	Trials
Completed	9
Not yet recruiting	3
Recruiting	2

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Clinical Trial Sponsors for Selexipag

Sponsor Name

Sponsor Name for Selexipag
Sponsor	Trials
Actelion	16

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Sponsor Type

Sponsor Type for Selexipag
Sponsor	Trials
Industry	16

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