Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension
Intervention: bosentan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Actelion
Summary
This is a multicenter, multinational, open label, non-comparative, phase III extension study
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.
Clinical Details
Official 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 AC-052-365 (Future 1)
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Treatment-emergent adverse eventsAdverse events leading to premature discontinuation of study drug Serious adverse events Changes from Baseline in vital signs, body weight, and height Treatment-emergent marked laboratory abnormalities
Secondary outcome: Change from Baseline from FUTURE 1 of WHO functional class, quality of life questionnaire, Global Clinical Impression Scale according to parents/legal guardians and physician
Eligibility
Minimum age: 2 Years.
Maximum age: 12 Years.
Gender(s): Both.
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.
Locations and Contacts
Hopital Antoine Beclere, Clamart 92140, France
Hopital Necker, Paris 75743, France
CHE de Toulouse Hopital d'Enfants, Toulouse, France
Deutsches Herzzentrum, Augustenburger, Germany
Universitats Kinderklinik, Giessen, Germany
Policlinico S. Orsola-Malpighi, Bologna 40138, Italy
Beatrix Children's Hospital, Groningen, Netherlands
Hopital des Enfants, Geneva, Switzerland
The Institute of Child Health, London, United Kingdom
The Children's Hospital Cardiac Care Center, Denver, Colorado 80218, United States
Columbia University Medical Center, New York, New York 10032, United States
Additional Information
Starting date: August 2005
Last updated: April 8, 2013
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