Overview

This trial is active, not recruiting.

Condition pulmonary arterial hypertension
Treatment macitentan
Phase phase 3
Sponsor Actelion
Start date October 2008
End date December 2018
Trial size 550 participants
Trial identifier NCT00667823, AC-055-303

Summary

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ACT-064992
macitentan ACT-064992
Tablet, oral administration, 10 mg dose once daily

Primary Outcomes

Measure
Number of subjects with treatment-emergent Adverse Events (AEs) and serious AEs
time frame: up to 28 days after study drug discontinuation, assessed for up to 55 months

Secondary Outcomes

Measure
Number of subjects with AEs leading to premature discontinuation of study drug
time frame: up to 28 days after study drug discontinuation, assessed for up to 55 months
Occurrence of treatment-emergent liver function test (ALT and/or AST) abnormality
time frame: up to 28 days after study drug discontinuation, assessed for up to 55 months
Occurence of treatment-emergent hemoglobin abnormality
time frame: up to 28 days after study drug discontinuation, assessed for up to 55 months

Eligibility Criteria

Male or female participants at least 12 years old.

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. 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.

Additional Information

Official title Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Actelion.