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

SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label) Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003694-27-GB

Enrollment

525

Registered

2007-11-26

Start date

2011-11-17

Completion date

Unknown

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatic pulmonary arterial hypertension MedDRA version: 17.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion 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. •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. •Men with a female partner of child-bearing potential must use a barrier method of contraception. 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension (PAH).;Secondary Objective: N/A;Primary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

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

Contacts

Public ContactGlobal Medical Information

Actelion Pharmaceuticals Ltd

medinfo@actelion.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026