EUCTR2007-006453-12-BEActive, not recruitingPhase 1
A multi-centre, multinational, open-label study to evaluate the long-term safety, tolerability and efficacy of selexipag / 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)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Actelion Pharmaceuticals Ltd
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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