Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertensio
- Conditions
- symptomatic pulmonary arterial hypertensionMedDRA version: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-003694-27-GB
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 525
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method