Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-2)

Actelion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Treatments

Drug: Macitentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02060721

AC-055E202

2013-003457-25 (EudraCT Number)

Details and patient eligibility

About

Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Exclusion criteria

Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.