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

Phase 1

• Conditions: The intended indication is Pulmonary Arterial Hypertension; MedDRA version: 14.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-014992-31-SK
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-09
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

1. Signed informed consent prior to initiation of any study-mandated procedure.
2. 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.
3. 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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any major violation of protocol AC-065A302.
2. Females who plan to become pregnant during the study, or are breastfeeding.
3. 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.
4. Known hypersensitivity to ACT-293987 or any of the excipients.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the long-term safety and tolerability of ACT-293987 in patients with pulmonary arterial hypertension (PAH).;Secondary Objective: ;Primary end point(s): No primary efficacy endpoint is considered for this OL study. The primary endpoint for this study is safety and tolerability.;Timepoint(s) of evaluation of this end point: After Visit 5, safety will be assessed every six months.