Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

• Status: Completed
• Trial end date: 2011-10-28
• Target enrollment: 0
• Participant gender: All

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 familial pulmonary arterial hypertension who completed FUTURE 1 study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.