Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-1)

Actelion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Treatments

Drug: Placebo

Drug: Macitentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT02021292

AC-055E201

Details and patient eligibility

About

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

Enrollment

80 patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
Female 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

Previous pulmonary endarterectomy.
Recurrent thromboembolism despite sufficient oral anticoagulants.
Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.