Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-1)

This study has been completed.
Information provided by (Responsible Party):
Actelion Identifier:
First received: December 20, 2013
Last updated: October 18, 2016
Last verified: October 2016
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

Condition Intervention Phase
Chronic Thromboembolic Pulmonary Hypertension
Drug: Macitentan
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • Pulmonary vascular resistance (PVR) at rest at Week 16 expressed as percent of baseline PVR at rest [ Time Frame: baseline to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD). [ Time Frame: baseline to Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6-minute walk test (6MWT). [ Time Frame: baseline to Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with worsening in WHO functional class from baseline to Week 24 [ Time Frame: baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: August 2014
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Drug: Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Other Name: ACT-064992
Placebo Comparator: Placebo
Matching placebo oral tablet, to be taken once daily.
Drug: Placebo
Matching placebo oral tablet, to be taken once daily.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease).
  • Female 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:

  • Previous pulmonary endarterectomy.
  • Recurrent thromboembolism despite sufficient oral anticoagulants.
  • Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.
  • Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value) or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema).
  • Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to Screening visit or during the Screening period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02021292

  Show 36 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Actelion Identifier: NCT02021292     History of Changes
Other Study ID Numbers: AC-055E201 
Study First Received: December 20, 2013
Last Updated: October 18, 2016
Health Authority: Switzerland: Swissmedic
China: Food and Drug Administration
United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Lithuania: State Medicine Control Agency - Ministry of Health
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Vietnam: Ministry of Health
Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Thailand: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
South Africa: Medicines Control Council
Ukraine: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Actelion:
Chronic thromboembolic pulmonary hypertension (CTEPH)

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists processed this record on December 06, 2016