NCT00667823

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Macitentan	Tablet, oral administration, 10 mg dose once daily

Timeline

• Start date: 2008-10-17
• Primary completion: 2020-12-07
• Completion: 2020-12-07
• First posted: 2008-04-28
• Last updated: 2025-03-30
• Results posted: 2022-02-10

Locations

158 sites across 36 countries: United States, Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russia, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United Kingdom