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).

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

sites

Royal Children's Hospital Melbourne, Cardiology - Site 5001

Parkville,

from

Parkville,