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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-001967-70-GB |
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Date of registration:
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25/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public 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 FUTURE 1 - FUTURE 2
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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 FUTURE 1 - FUTURE 2 |
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Date of first enrolment:
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13/10/2005 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001967-70 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
Other trial design description: Open-Label extension study
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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Italy
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United Kingdom
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Contacts
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Affiliation:
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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.
· Male or female >= 2 and < 12 years of age at enrollment in FUTURE 2.
Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
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:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Idiopathic or familial pulmonary arterial hypertension
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Intervention(s)
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Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 147536-97-8
Current Sponsor code: Ro 47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 32-
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Primary Outcome(s)
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Main Objective: To assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with IPAH or familial PAH.
The primary endpoint analysis will be the analysis of tolerability and safety endpoints:
· Treatment-emergent adverse events up to 24 hours after permanent discontinuation of study drug.
· Adverse events leading to premature discontinuation of study drug.
· Serious adverse events up to 28 days after permanent discontinuation of study drug.
· Changes from baseline to Study End in vital signs, body weight, and height.
· Treatment-emergent marked laboratory abnormalities.
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Primary end point(s): In addition to long-term tolerability and safety information, the FUTURE 2 study will provide an opportunity to assess quality of life and functional status of the paediatric population using the new formulation.
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Secondary Objective: Exploratory efficacy endpoints:
· Change from Baseline in FUTURE 1 to Study End or Premature study drug discontinuation (FUTURE 1 or 2) in:
- WHO functional class
- Quality of life questionnaire (SF-10 for childrenTM)
- Global Clinical Impression scale according to the parents/legal representatives
- Global Clinical Impression scale according to the physician
· From Baseline in FUTURE 1, time to worsening of PAH, defined as death or transplantation or hospitalization for PAH worsening.
· From Baseline in FUTURE 1, time to worsening of PAH or initiation of new therapy for PAH or new right heart failure or worsening of right heart failure.
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Secondary ID(s)
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AC-052-367
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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