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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 89 Years
Gender All
More Inclusion & Exclusion Criteria

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
  • - Subjects treated with anti-coagulation agents, unfractionated heparin or low molecular weight heparin at least 90 days prior to RHC at baseline - Women with childbearing potential with negative serum pregnancy test results and able to follow the appropriate contraceptive methods from the date of starting the study drug administration up to 30 days after the discontinuation or completion of the study drug administration.
Fertile male subjects able to use condom during the same period.

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03809650
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yoshinari Yokoyama, PhD
Principal Investigator Affiliation Actelion Japan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOtherOtherOtherOther
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Yokohama City University Hospital, Yokohama, Japan

Status

Recruiting

Address

Yokohama City University Hospital

Yokohama, , 236-0004

Mie University Hospital, Tsu, Japan

Status

Recruiting

Address

Mie University Hospital

Tsu, , 514-8507

Suita, Japan

Status

Recruiting

Address

National Cerebral and Cardiovascular Center Hospital

Suita, , 565-8565

Sasebo City General Hospital, Sasebo, Japan

Status

Recruiting

Address

Sasebo City General Hospital

Sasebo, , 857-8511

Hokkaido University, Sapporo, Japan

Status

Recruiting

Address

Hokkaido University

Sapporo, , 060-8648

Sapporo Medical University Hospital, Sapporo, Japan

Status

Recruiting

Address

Sapporo Medical University Hospital

Sapporo, , 060-8543

Okayama, Japan

Status

Recruiting

Address

National Hospital Organization Okayama Medical Center

Okayama, , 701-1192

Nagasaki University Hospital, Nagasaki, Japan

Status

Recruiting

Address

Nagasaki University Hospital

Nagasaki, , 852-8501

IIUHW Mita Hospital, Minato-ku, Japan

Status

Recruiting

Address

IIUHW Mita Hospital

Minato-ku, , 108-8329

Toho University Ohashi Medical Center, Meguro-ku, Japan

Status

Recruiting

Address

Toho University Ohashi Medical Center

Meguro-ku, , 153-8515

Kurume University Hospital, Kurume, Japan

Status

Recruiting

Address

Kurume University Hospital

Kurume, , 830-0011

Kure Kyosai Hospital, Kure, Japan

Status

Recruiting

Address

Kure Kyosai Hospital

Kure, , 737-8505

Kumagaya, Japan

Status

Recruiting

Address

Saitama Cardiovascular and Respiratory Center

Kumagaya, , 360-0197

Kobe University Hospital, Kobe, Japan

Status

Recruiting

Address

Kobe University Hospital

Kobe, , 650-0017

Kokura Kinen Hospital, Kitakyushu, Japan

Status

Recruiting

Address

Kokura Kinen Hospital

Kitakyushu, , 802-8555

Nara Medical University Hospital, Kashihara, Japan

Status

Recruiting

Address

Nara Medical University Hospital

Kashihara, , 634-8522

Kagoshima University Hospital, Kagoshima, Japan

Status

Recruiting

Address

Kagoshima University Hospital

Kagoshima, , 890-8520

Fukushima Medical University Hospital, Fukushima, Japan

Status

Recruiting

Address

Fukushima Medical University Hospital

Fukushima, , 960-1247

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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