Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertensio

Phase 1

• Conditions: symptomatic pulmonary arterial hypertension; MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-003694-27-BG
• Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-12
• Study Completion: 2020-12-07
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

•Signed informed consent prior to initiation of any study-mandated procedure.
•Patients with pulmonary arterial hypertension and having completed the event-driven study, AC-055-302/SERAPHIN, or
Patients who have experienced a clinical worsening of PAH in AC-055-302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
•Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 513
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

Exclusion Criteria

•Any major violation of protocol AC-055-302/SERAPHIN.
•Pregnancy or breast-feeding.
•AST and/or ALT > 3 times the upper limit of the normal range.
•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-064992 or any of the excipients.

Study & Design

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