A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day.
- Conditions
- Health Condition 1: null- Pulmonary arterial Hypertension
- Registration Number
- CTRI/2012/05/002685
- Lead Sponsor
- ACTELION Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 64
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).
3. Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.
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.
3. Pregnancy
4. AST and/or ALT values 3 times the upper limit of normal range (ULN)
5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
6. Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373).
7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o primary endpoint has been defined for this open-label, exploratory extension study. This is an exporatory study.Timepoint: 12 months of treatment.
- Secondary Outcome Measures
Name Time Method o primary endpoint has been defined for this open-label, exploratory extension study. This is an exporatory study.Timepoint: 12 months of treatment.