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A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

NCT03809650•Actelion

View on ClinicalTrials.gov

Summary

The endothelin receptor antagonist macitentan showed significant improvement compared with placebo in pulmonary vascular resistance (PVR) and 6-minute walking distance (6MWD) in inoperable CTEPH patients in the phase II MERIT-1 trial (AC-055E201, NCT02021292). However, in the MERIT-1 trial Japanese patients were not included. Therefore, in line with Japan's medical environment, this phase III study is to confirm the efficacy and safety of macitentan in Japanese CTEPH patients.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent to participate in the study obtained from the subject or legal representative a) prior to initiation of any study mandated procedure
•Japanese subjects who have been diagnosed as having CTEPH:
•1. Subjects who have not undergone balloon pulmonary angioplasty (BPA) and for whom the investigator determines not to implement pulmonary endarterectomy (PEA) at the time of the acquisition of informed consent due to the organized thrombosis localized in the peripheral regions, high risk (complications, old age, etc.) or for any other reasons.
•2. Subjects who have postoperative persistent or recurrent pulmonary hypertension (PH) after undergoing pulmonary endarterectomy (PEA) and/or BPA.
•PH subjects whose WHO FC is I to IV
•6MWD measured during the screening period ranges from 150 m to 450 m
•Subjects who meet the following conditions according to the right heart catheterization (RHC) performed during the screening period or within 8 weeks before the acquisition of the informed consent:
•1. Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
•2. Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg (if PAWP cannot be measured or the value of PAWP is not reliable, left ventricular end-diastolic pressure ≤ 13 mmHg)
•3. Resting PVR ≥ 400 dyn\*sec/cm5
+2 more criteria

Exclusion Criteria

•BPA within 90 days prior to undergoing baseline RHC
•PEA within 180 days prior to undergoing baseline RHC
•Subjects with unstable pulmonary hemodynamics who have postoperative persistent or recurrent PH after undergoing PEA and/or BPA
•Recurrent thromboembolism undergoing treatment with oral anti-coagulation agents
•Symptomatic acute pulmonary embolism within 180 days prior to the start of study drug administration
•Known moderate-to-severe restrictive lung disease or obstructive lung disease or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema)
•Acute myocardial infarction during Screening period
•Severe liver impairment.
•Systolic blood pressure (SBP) \< 90 mmHg at screening.
•Any known factor or disease that may interfere with treatment compliance or full participation in the study

Locations (23)

Fukuoka University Nishijin Hospital

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Kagoshima University Hospital

Kagoshima, Japan

Nara Medical University Hospital

Kashihara, Japan

Kokura Kinen Hospital

Kitakyushu, Japan

Kobe University Hospital

Kobe, Japan

Saitama Cardiovascular and Respiratory Center

Kumagaya, Japan

Kure Kyosai Hospital

Kure, Japan

Kurume University Hospital

Kurume, Japan

Toho University Ohashi Medical Center

Meguro-ku, Japan

Key Dates

Start Date

January 8, 2019

Primary Completion Date

June 29, 2020

Completion Date

June 29, 2020

Last Updated

June 18, 2021

Enrollment

ACTUAL participants

Conditions

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Interventions

macitentan 10 mg

DRUG

What is the Role of the Exposome in Pulmonary Hypertension

NCT07172334

Pulmonary Arterial Hypertension (PAH)Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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