CompletedPhase 2

Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)

Austria, Belgium, France43 participantsStarted 2008-04-30

Plain-language summary

This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo an open-label, single-dose acute hemodynamic study with ACT-293987(NS-304) and 21 weeks of double-blind treatment during which subjects will receive either ACT-293987 (NS-304) or placebo b.i.d. Subjects who have completed the double-blind study can enter the open extension study (separate protocol) and receive administration of ACT-293987 (NS-304) if the subject wishes and the Investigator considers it appropriate.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male and female subjects 18 years of age or older with symptomatic PAH despite treatment with anticoagulants, calcium channel blockers, diuretics, cardiac glycosides, supplemental oxygen, endothelin-receptor antagonists and/or phosphodiesterase inhibitors. Endothelin receptor antagonists and phosphodiesterase inhibitors must have been used at a stable dose for more than 12 weeks before screening.
✓. Subjects with idiopathic PAH, familial pulmonary arterial hypertension and PAH associated with collagen vascular disease, corrected congenital vitium (congenital systemic to pulmonary shunts surgically repaired at least five years before) or anorexigen use.
✓. Diagnosis of PAH established according to the standard criteria:
✓. Resting mean pulmonary arterial pressure \> 25 mmHg.
✓. PVR \> 240 dynes s/cm5.
✓. Pulmonary capillary wedge pressure or left ventricular end diastolic pressure \< 15 mmHg.
✓. PVR \> 400 dynes s/cm5.
✓. Two 6MWTs between 150 and 500 m (inclusive) with the variation in 6MWT within ± 15% between the two tests despite other treatments for PAH.

Exclusion criteria

What they're measuring

Assessment of hemodynamic parameters after single oral dose of ACT-293987.

Timeframe: 17 weeks

Proof-of-concept assessment of the efficacy of ACT-293987 in subjects with PAH by measuring the change from baseline in the PVR at Week 17 compared to placebo.

Timeframe: 17 weeks

Trial details

NCT IDNCT00993408

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06-30

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