Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

Phase 3CompletedNCT00319020

Actelion33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

BosentanDRUG

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change From Baseline to End of Study (EOS) in Height for Age.

In order to compare the growth data with those of healthy children, growth curves are calculated from height data collected throughout the follow-up period. For each patient, height measured at each study visit was converted to a z-score and expressed in standard deviations (SD) from WHO growth standards. The Z-score was calculated according to the following formula: Z-score = (observed value of the study participant - median value of the reference population) / SD value of the reference population

Time frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average

Change From Baseline to End of Study (EOS) in Body Weight

The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including growth as measured by changes from baseline in body weight and height.

Time frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average

Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP)

The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.

Time frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average

Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP)

The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including changes from baseline in blood pressure.

Time frame: From baseline (FUTURE 1) up to 28 days after study treatment discontinuation (EOS or premature study treatment discontinuation), i.e. 32 months in average

Change From Baseline to End of Study (EOS) in Pulse Rate

Data from ClinicalTrials.gov

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