Bosentan in Children With Pulmonary Arterial Hypertension Extension Study (FUTURE 2)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319020

2005-001967-70 (EudraCT Number)

AC-052-367

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Bosentan

Experimental group

Description:

Bosentan was administered at 4 mg/kg twice daily (b.i.d.) until the end of the study. It could be down-titrated to 2 mg/kg b.i.d. if not well tolerated.

Treatment:

Drug: Bosentan