Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome (MAESTRO-OL)

Actelion Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Macitentan 10 mg tablet, once daily.

Study type: Interventional

Funder types: Industry

Identifiers

NCT01739400

AC-055-308

Details and patient eligibility

About

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Enrollment: 217 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects with ES (including those with Down Syndrome) having completed the double-blind AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to Week 16 (whether or not they were still taking study drug at the end of this period).

Exclusion criteria

Subjects who prematurely discontinue double-blind study drug during the AC-055-305 / MAESTRO study due to:

• an AE assessed as related to the use of study drug,
• or elevated liver tests (related or unrelated to study drug).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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217 participants in 1 patient group

Macitentan

Experimental group

Description:

Macitentan 10 mg tablet, once daily.

Treatment:

Drug: Macitentan 10 mg tablet, once daily.