FUTURE 3 Study Extension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01338415
• Date of registration: 15/04/2011
• Prospective Registration: No
• Primary sponsor: Actelion
• Public title: FUTURE 3 Study Extension FUTURE 3 Ext
• Scientific title: 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
• Date of first enrolment: March 8, 2011
• Target sample size: 58
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01338415
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Belarus, China, Czech Republic, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States

Key inclusion & exclusion criteria

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.



Age minimum: 3 Months
Age maximum: 12 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Bosentan

Primary Outcome(s)

Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation [Time Frame: Up to 62 weeks in average]

Secondary ID(s)

2010-021793-12

AC-052-374

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01338415