An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH)
Phase 3
Completed
- Conditions
- Pulmonary arterial hypertension10037454
- Registration Number
- NL-OMON39075
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
Inclusion Criteria
1. Signed informed consent prior to initiation of any study mandated procedure;2. Patients who completed participation in study AC 066A301;3. Patients who have not obtained access (i.e. reimbursement) to commercial EFI at the time of ending participation in study AC-066A301
Exclusion Criteria
1. Patients who prematurely discontinued study drug in study AC-066A301;2. Patients for whom continued treatment with EFI is no longer considered appropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Treatment-emergent adverse events (AEs) up to 24 hours post-EOT<br /><br>• Adverse events leading to premature discontinuation of study drug<br /><br>• Treatment-emergent</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>