Last updated on September 2020

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

Brief description of study

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Detailed Study Description

CTEPH is one of the leading causes of severe pulmonary hypertension (PH), classified within World Health Organization (WHO) group 4 PH. It is a rare, progressive pulmonary vascular disease that if left untreated, leads to progressively increasing pulmonary vascular resistance (PVR) and eventually right ventricle failure and death. Histopathologic findings including endothelial cell dysfunction and distal pulmonary arterial remodeling are shared between PAH and CTEPH, and PH-specific therapies (that is, riociguat) have shown efficacy in inoperable and persistent/recurrent CTEPH. The endothelin receptor antagonist macitentan offers a different mode of action and addresses an important unmet medical need for an alternative treatment option in this indication. This study will assess the effect of macitentan 75 mg on exercise capacity and is expected to confirm the role of macitentan as a first line, as well as add-on treatment for CTEPH. The study comprises of screening period (at least 14- and up to 60 days), a 52-week double-blind (DB) treatment period (which includes an 8-week up-titration phase), an open-label (OL) extension period (which starts at Week 52 and will end for all participants 104 weeks after the last participant has completed the DB treatment period) and 30-day safety follow-up period. Participants who discontinue DB study intervention will be followed until Week 52 in a post-treatment-observation period (PTOP). The total duration of the study is approximately 6 years.

Clinical Study Identifier: NCT04271475

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USC Keck

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University of Florida

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University of Miami

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The Oregon Clinic

Portland, OR United States
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University of Pennsylvania

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St Vincent's hospital

Darlinghurst, Australia
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Asan Medical Center

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Papworth Hospital NHS Trust

Cambridge, United Kingdom
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Royal Free Hospital

London, United Kingdom
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Freeman Hospital

Newcastle Upon Tyne, United Kingdom
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Recruitment Status: Open

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