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

2014-07-23 21:12:29 | BioPortfolio

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.

Description

This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by a randomized, double-blind, parallel-group, placebo controlled study. Eligible subjects will undergo screening followed by randomized allocation to treatment group for the double-blind study, followed in turn by immediate enrollment in 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 twice daily (b.i.d.). Subjects who have completed the double-blind study can enter the open extension study and receive administration of ACT-293987 (NS-304) (separate protocol)if the subject wishes and the investigator considers it appropriate.

Unblinding will occur on a subject-by-subject basis when the Week 17 data for the subject have been fixed.

Approximately 44 subjects are to be randomized in a ratio of 3:1 to the two treatment groups, ACT-293987 (NS-304) and placebo (33 subjects to ACT-293987 (NS-304) and 11 subjects to placebo).

Subjects will be randomized to the study following screening.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment

Conditions

Pulmonary Arterial Hypertension

Intervention

ACT-293987 (NS-304)

Location

Medizinische Universitat Wien, Universitatsklinik fur Innere Medizin II, Kardiologie
Vienna
Austria
1090

Status

Completed

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:29-0400

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Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...


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