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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00319020 |
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Date of registration:
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26/04/2006 |
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Primary sponsor: |
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Public title:
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Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
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Scientific title:
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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) |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00319020 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Germany
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Italy
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Netherlands
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Switzerland
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: bosentan
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Primary Outcome(s)
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Adverse events leading to premature discontinuation of study drug
[Time Frame: discontinuation of study]
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Changes from Baseline in vital signs, body weight, and height
[Time Frame: End of Study]
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Serious adverse events
[Time Frame: up to 28 days after permanent discontinuation of study drug]
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Treatment-emergent adverse events
[Time Frame: up to 24 hours after discontinuation]
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Treatment-emergent marked laboratory abnormalities
[Time Frame: Discontinuation of study]
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Secondary Outcome(s)
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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
[Time Frame: Study End or premature study drug discontinuation]
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Secondary ID(s)
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AC-052-367
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FUTURE 2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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