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

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Pulmonary Arterial Hypertension; MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-28
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

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

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), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302. - 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 447
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 223

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 clinical trial of medicinal product
• Study Design: Not specified