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 hypertensio

Phase 3

Completed

• Conditions: high bloodpressure in the lungs; PH; 10007510; 10037454

• Registration Number: NL-OMON36321
• Lead Sponsor: Actelion Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>No primary endpoint was defined in this study</p><br>