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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02021292
First Posted: December 27, 2013
Last Update Posted: September 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Actelion
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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: From baseline to Week 16 ]

Secondary Outcome Measures:
  • Change from baseline to Week 24 in exercise capacity, as measured by the 6-minute walk distance (6MWD). [ Time Frame: From baseline to Week 24 ]
  • Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6-minute walk test (6MWT). [ Time Frame: From baseline to Week 24 ]
    This outcome measures the difference in the Borg dyspnea index at Week 24 and baseline. The index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal').

  • Proportion of subjects with worsening in WHO functional class from baseline to Week 24 [ Time Frame: From baseline to Week 24 ]

Enrollment: 80
Actual Study Start Date: August 20, 2014
Study Completion Date: September 28, 2016
Primary Completion Date: September 28, 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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021292


  Show 36 Study Locations
Sponsors and Collaborators
Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02021292     History of Changes
Other Study ID Numbers: AC-055E201
First Submitted: December 20, 2013
First Posted: December 27, 2013
Last Update Posted: September 5, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists