FUTURE 3 Study Extension
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 12 |
| Updated: | 12/13/2017 |
| Start Date: | March 8, 2011 |
| End Date: | August 13, 2014 |
A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety,
tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
day in children with Pulmonary Arterial Hypertension (PAH).
tolerability and efficacy of the pediatric formulation of bosentan two versus three times a
day in children with Pulmonary Arterial Hypertension (PAH).
Inclusion Criteria:
1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely
discontinued due to PAH-progression, if bosentan was not permanently discontinued
2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is
considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
3. Signed informed consent by the parents or the legal representatives prior to any
study-mandated procedure.
Exclusion Criteria:
1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the
dispersible bosentan tablet
2. Any clinically significant laboratory abnormality that precludes continuation of
bosentan therapy
3. Pregnancy
4. AST and/or ALT values > 3 times the upper limit of normal range (ULN)
5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
6. Premature and permanent study drug discontinuation during the FUTURE 3 core study
(AC-052-373)
7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
We found this trial at
6
sites
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New York, New York 10032
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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