Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-23

Study Completion Date

2011-10-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bosentan

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.

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally

Interventions

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Bosentan

32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally

Intervention Type DRUG

Other Intervention Names

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Ro 47-0203 Tracleer

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No