Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertensio

Phase 1

• Conditions: pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use; MedDRA version: 18.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-07
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 willing and able 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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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
2) Females who are breast-feeding, pregnant or plan to become pregnant during the study and females who are not using a highly effective method of birth control (failure rate less than 1% per year) such as implants, injectables, combined oral contraceptives, some
intrauterine devices, sexual abstinence or vasectomised partner.

Study & Design

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