Skip to main content
OpenTrials
Completed

NCT Number: NCT02060721

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
  • Females 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

  • Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
  • Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Treatment and study plan

Macitentan

Drug

Macitentan 10mg, oral tablet, once daily

Other names: ACT-064992

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

    An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.

  2. Number of Participants With AEs Leading to Study Drug Discontinuation

    Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

    Number of participants with AEs leading to study drug discontinuation was reported.

  3. Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

    A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.

  4. Number of Participants With Hemoglobin Abnormalities

    Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

    Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (<) 80 grams per liter (g/L), hemoglobin <100 g/L, hemoglobin greater than or equal to (>=) 80 g/L and <100 g/L, hemoglobin <100g/L and a decrease of >20 g/L from baseline, decrease of >20 g/L in hemoglobin from baseline, decrease of >20 g/L and <=50 g/L in hemoglobin from baseline, and decrease of >50 g/L in hemoglobin from baseline.

  5. Number of Participants With Liver Tests Abnormalities

    Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

    Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): >=3 x Upper limit of the normal range (ULN), >=3 and <5 x ULN, >=5 ULN, and >=5 and <8 x ULN, >= 8 x ULN, and total bilirubin >=2 x ULN.

  6. Change From Baseline in Blood Pressure at Month 6

    Time frame: Baseline and Month 6

    Change from baseline in blood pressure at Month 6 (both systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was reported.

  7. Change From Baseline in Pulse Rate at Month 6

    Time frame: Baseline and Month 6

    Change from baseline in pulse rate at Month 6 was reported.

  8. Change From Baseline in Body Weight at Month 6

    Time frame: Baseline and Month 6

    Change from baseline in body weight at Month 6 was reported.

Sponsors and collaborators

Lead sponsor

Actelion

Industry

Registry information

Official study title

MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Acronym: MERIT-2

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 12, 2014
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.