Status:
COMPLETED
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 symptoma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2020
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00667823
Start Date
October 17 2008
End Date
December 7 2020
Last Update
March 30 2025
Active Locations (158)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249-0001
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85012
3
University of California, San Diego
La Jolla, California, United States, 92037
4
GLVA Healthcare Center
Los Angeles, California, United States, 90073