FUTURE 3 extension study.
- Conditions
- Pulmonary arterial hypertension in children
- Registration Number
- NL-OMON27501
- Lead Sponsor
- Actelion PharmaceuticalsGewerbestrasse 16 CH-4123 Allschwil Switzerland
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH progression, if bosentan was not permanently discontinued;
2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial by the investigator at the end of FUTURE 3 core study (AC-052-373);
Exclusion Criteria
1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet;
2. Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o primary endpoint was defined in this study.
- Secondary Outcome Measures
Name Time Method