Status:
COMPLETED
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief Summary
The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or fam...
Eligibility Criteria
Inclusion
- Signed informed consent by the parents or the legal representatives.
- Patients who completed the FUTURE 1 study.
- Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
- Males or females \>= 2 and \< 12 years of age at enrollment in FUTURE 2 (this study). Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
Exclusion
- Intolerance to bosentan despite dose reductions.
- Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
- Pregnancy or breast-feeding.
- Known hypersensitivity to bosentan or any of the excipients.
- Premature and permanent study drug discontinuation during FUTURE 1.
Key Trial Info
Start Date :
August 23 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00319020
Start Date
August 23 2005
End Date
October 28 2011
Last Update
February 4 2025
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