ong-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertensio

Phase 3

Completed

Conditions: Pulmonary arterial hypertension
hypertension in lung arteries
10037454

Registration Number: NL-OMON41513

Lead Sponsor: Actelion Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

- Signed informed consent prior to initiation of any study-mandated procedure.
- Patients who have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study).
- Women of child-bearing potential included in study AC-065A303 must use a reliable method of contraception (with a failure rate of less than 1% per year) until one month after study drug discontinuation.

Exclusion Criteria

- Pediatric patients (i.e., < 18 years of age).
- Patients who are not able to perform the Visit 1 of AC-065A303/GRIPHON OL within 2 weeks (i.e., 14 days) of the last visit in AC-065A302/GRIPHON.
- Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
- 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 selexipag (ACT-293987) or any of the excipients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>No primary efficacy endpoint is considered for this open label extension study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and Tolerability endpoints:<br /><br>* Treatment-emergent AEs up to 3 days after study drug discontinuation.<br /><br>* Treatment-emergent SAEs up to 3 days after study drug discontinuation.<br /><br>* AEs leading to premature discontinuation of study drug.</p><br>