A multi-centre, multinational, open- label study to evaluate the long-term safety, tolerability and efficacy of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over (open-extension study to NS-304/-02)

Phase 1

• Conditions: pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrcted congenital vitium or anorexigen; MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension; MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension; MedDRA version: 9.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension; MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension

• Registration Number: EUCTR2007-006453-12-GB
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-15
• Study Completion: 2017-12-19
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 39

Inclusion Criteria

1) Subjects who have completed the preceding double-blind study (NS-304/-02)
2) Subjects who have signed informed consent for participation in the open-extension study
3) Subjects who are able and willing to refrain from sunbathing, prolonged sun exposure and artificial sunlight exposure such as solarium use or UVA/UVB treatment, and to limit skin and eye exposure to sunlight using appropriate precautions (protective clothing, sunscreen and sunglasses) from the first dose until 14 days after study drug discontinuation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subjects with medically abnormal findings (ECG, physical examination, AEs) at the end of visit 7 of the preceding double-blind study that investigators considers not appropriate to enter this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified