Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
This study has been completed.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00319020
First received: April 26, 2006
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: bosentan |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
pulmonary arterial hypertension
Drug Information available for:
Bosentan
U.S. FDA Resources
Further study details as provided by Actelion:
Primary Outcome Measures:
- Treatment-emergent adverse events [ Time Frame: up to 24 hours after discontinuation ] [ Designated as safety issue: Yes ]
- Adverse events leading to premature discontinuation of study drug [ Time Frame: discontinuation of study ] [ Designated as safety issue: Yes ]
- Serious adverse events [ Time Frame: up to 28 days after permanent discontinuation of study drug ] [ Designated as safety issue: Yes ]
- Changes from Baseline in vital signs, body weight, and height [ Time Frame: End of Study ] [ Designated as safety issue: Yes ]
- Treatment-emergent marked laboratory abnormalities [ Time Frame: Discontinuation of study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | August 2005 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
32 mg breakable tablets
|
Drug: bosentan
32 mg breakable tablets 4 mg maintenance dose
Other Name: Tracleer
|
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319020
Locations
| United States, Colorado | |
| The Children's Hospital Cardiac Care Center | |
| Denver, Colorado, United States, 80218 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| France | |
| Hopital Antoine Beclere | |
| Clamart, France, 92140 | |
| Hopital Necker | |
| Paris, France, 75743 | |
| CHE de Toulouse Hopital d'Enfants | |
| Toulouse, France | |
| Germany | |
| Deutsches Herzzentrum | |
| Augustenburger, Germany | |
| Universitats Kinderklinik | |
| Giessen, Germany | |
| Italy | |
| Policlinico S. Orsola-Malpighi | |
| Bologna, Italy, 40138 | |
| Netherlands | |
| Beatrix Children's Hospital | |
| Groningen, Netherlands | |
| Switzerland | |
| Hopital des Enfants | |
| Geneva, Switzerland | |
| United Kingdom | |
| The Institute of Child Health | |
| London, United Kingdom | |
Sponsors and Collaborators
Actelion
More Information
No publications provided
| Responsible Party: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00319020 History of Changes |
| Other Study ID Numbers: | AC-052-367, FUTURE 2 |
| Study First Received: | April 26, 2006 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Actelion:
|
pulmonary arterial hypertension bosentan children FUTURE 1 |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
Bosentan Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013