FUTURE 3 Study Extension (FUTURE 3 Ext)

Actelion Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Bosentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01338415

2010-021793-12 (EudraCT Number)

AC-052-374

Details and patient eligibility

About

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).

Enrollment: 58 patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

bosentan 2mg/kg b.i.d.

Experimental group

Description:

Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study

Treatment:

Drug: Bosentan

bosentan 2mg/kg t.i.d.

Experimental group

Description:

Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study

Treatment:

Drug: Bosentan