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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).

NCT03809650 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-06-18

No results posted yet for this study

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.

Conditions

  • Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Interventions

DRUG

macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Sponsors & Collaborators

  • EPS Corporation

    collaborator OTHER

  • Imepro Inc.

    collaborator UNKNOWN

  • General Laboratory, BML, Inc.

    collaborator UNKNOWN

  • Mitsubishi Logistics Corporation

    collaborator UNKNOWN

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Yoshinari Yokoyama, PhD · Actelion Japan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2020-06-29
Completion
2020-06-29

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809650 on ClinicalTrials.gov