CompletedPhase 3

Bosentan in Children With Pulmonary Arterial Hypertension Extension Study

33 participantsStarted 2005-08-23

Plain-language 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.

Who can participate

Age range2 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

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

Proportion of Patients With Treatment-emergent Liver Function Abnormalities

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

Trial details

NCT IDNCT00319020

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-10-28

Results submitted2017-02-09

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range2 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

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

Proportion of Patients With Treatment-emergent Liver Function Abnormalities

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