ong term study to evaluate if Selexipag is safe and tolerated in the patients who have participated in AC-065A302 (GRIPHON) study
Phase 3
- Conditions
- Health Condition 1: null- Pulmonary Arterial Hypertension - the study is available only for those patients who have participated in GRIPHON study
- Registration Number
- CTRI/2012/05/002676
- Lead Sponsor
- ACTELION Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 670
Inclusion Criteria
•Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302.
•Signed informed consent
Exclusion Criteria
•Any major violation of protocol AC-065A302.
•Females who plan to become pregnant during the study, or are breastfeeding.
•Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.
•Known hypersensitivity to ACT-293987 or any of the excipients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of Participants with Adverse Events as a Measure of Safety and TolerabilityTimepoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Designated as safety issue: Yes
- Secondary Outcome Measures
Name Time Method o secondary outcome as the primary outcome measures the long term safety and tolerabilityTimepoint: Not applicable