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Completed

NCT Number: NCT00319020

Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

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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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bosentan

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

Other names: Ro 47-0203, Tracleer

Primary outcomes

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

    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

    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

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

    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

    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.

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

    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

    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.

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

    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

    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.

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

    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

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

  6. Proportion of Patients With Treatment-emergent Liver Function Abnormalities

    Time frame: After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average

    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including laboratory abnormalities related to liver enzymes.

    Proportion of patients with increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 3 times upper limit of normal (ULN) is reported here.

  7. Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities

    Time frame: After baseline, up to 1 calendar day after study treatment discontinuation in FUTURE 1 or FUTURE 2, i.e. 31 months in average

    The main study objective was to assess the long-term safety and tolerability of bosentan in children with PAH, including hemoglobin abnormalities.

    Proportion of patients with marked hemoglobin decreases (i.e., decrease of or above 15% of the lower normal limit (LL)) is reported here.

  8. Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment

    Time frame: From the first study drug administration in FUTURE 1, for an average of 31 months

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1

Acronym: FUTURE 2

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2006
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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