Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT00667823
• Date of registration: 24/04/2008
• Prospective Registration: Yes
• Primary sponsor: Actelion
• Public title: Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension SERAPHIN OL
• Scientific 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
• Date of first enrolment: October 17, 2008
• Target sample size: 550
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00667823
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Key inclusion & exclusion criteria

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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Macitentan

Primary Outcome(s)

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 Outcome(s)

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]

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]

Secondary ID(s)

AC-055-303

Source(s) of Monetary Support

Please refer to primary and secondary sponsors