Phase 3
N=36
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00319020 ↗Enrolled (actual)
36
Serious AEs
50.0%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline to End of Study (EOS) in Height for Age. — -0.8; 0.32; -0.64; -0.74 Z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bosentan (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to End of Study (EOS) in Height for Age. |
-0.8; 0.32; -0.64; -0.74; -0.08; -0.36 | — |
| PRIMARY Change From Baseline to End of Study (EOS) in Body Weight |
19.6; 21.6; 19.6; 8.2; 8.5; 8.3 | — |
| PRIMARY Change From Baseline to End of Study (EOS) in Systolic Blood Pressure (SBP) |
101.5; 104; 102.5; -10.5; 4; -4.5 | — |
| PRIMARY Change From Baseline to End of Study (EOS) in Diastolic Blood Pressure (DBP) |
54.5; 60; 59; -5; -2; -3 | — |
| PRIMARY Change From Baseline to End of Study (EOS) in Pulse Rate |
87; 94.5; 88; -11; -10; -11 | — |
| PRIMARY Proportion of Patients With Treatment-emergent Liver Function Abnormalities |
0; 4.8; 2.8; 0; 4.8; 2.8 | — |
| PRIMARY Proportion of Patients With Treatment-emergent Hemoglobin Abnormalities |
13.3; 9.5; 11.1 | — |
| PRIMARY Number of Subjects With Adverse Events Leading to Premature Discontinuation of Study Treatment |
1; 5; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00319020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.