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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)

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ClinicalTrials.gov Identifier: NCT02021292
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : January 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:
Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Drug: Macitentan Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Actual Study Start Date : August 20, 2014
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. [ Time Frame: From baseline to Week 16 ]
    The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.


Secondary Outcome Measures :
  1. 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 ]
    The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

  2. 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 collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.

  3. Proportion of Subjects With Worsening in WHO Functional Class From Baseline to Week 24 [ Time Frame: From baseline to Week 24 ]

    WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure.

    Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'.




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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
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.

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
Investigators
Study Chair: Kelly Papadakis, MD Actelion

Publications of Results:
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT02021292     History of Changes
Other Study ID Numbers: AC-055E201
First Posted: December 27, 2013    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: February 23, 2018
Last Verified: December 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