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Trial record 1 of 4 for:    MERIT-1
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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)

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.
 
ClinicalTrials.gov Identifier: NCT02021292
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : January 23, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE December 20, 2013
First Posted Date  ICMJE December 27, 2013
Results First Submitted Date  ICMJE September 26, 2017
Results First Posted Date  ICMJE January 23, 2018
Last Update Posted Date July 26, 2018
Actual Study Start Date  ICMJE August 20, 2014
Actual Primary Completion Date September 28, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
PVR at rest at Week 16 expressed as percent of baseline PVR at rest [ Time Frame: baseline to Week 16 ]
Change History Complete list of historical versions of study NCT02021292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • 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.
  • 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.
  • Proportion of Subjects With Worsening in WHO Functional Class (FC) 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'.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • Change from baseline to Week 24 in exercise capacity, as measured by the 6MWD. [ Time Frame: baseline to Week 24 ]
  • Change from baseline to Week 24 in Borg dyspnea index collected at the end of the 6MWT. [ Time Frame: baseline to Week 24 ]
  • Proportion of subjects with worsening in WHO FC from baseline to Week 24 [ Time Frame: baseline to Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Thromboembolic Pulmonary Hypertension
Intervention  ICMJE
  • Drug: Macitentan
    Macitentan 10 mg, oral tablet, to be taken once daily.
    Other Name: ACT-064992
  • Drug: Placebo
    Matching placebo oral tablet, to be taken once daily.
Study Arms  ICMJE
  • Experimental: Macitentan
    Macitentan 10 mg, oral tablet, to be taken once daily.
    Intervention: Drug: Macitentan
  • Placebo Comparator: Placebo
    Matching placebo oral tablet, to be taken once daily.
    Intervention: Drug: Placebo
Publications * Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jaïs X, Jenkins DP, Jing ZC, Madani MM, Martin N, Mayer E, Papadakis K, Richard D, Kim NH; MERIT study investigators. Macitentan for the treatment of inoperable chronic thromboembolic pulmonary hypertension (MERIT-1): results from the multicentre, phase 2, randomised, double-blind, placebo-controlled study. Lancet Respir Med. 2017 Oct;5(10):785-794. doi: 10.1016/S2213-2600(17)30305-3. Epub 2017 Sep 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2017)
80
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
78
Actual Study Completion Date  ICMJE September 28, 2016
Actual Primary Completion Date September 28, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   China,   Czechia,   France,   Germany,   Hungary,   Korea, Republic of,   Lithuania,   Mexico,   Poland,   Russian Federation,   Switzerland,   Thailand,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Austria,   Bulgaria,   Canada,   Chile,   Czech Republic,   Italy,   Netherlands,   South Africa,   United States,   Vietnam
 
Administrative Information
NCT Number  ICMJE NCT02021292
Other Study ID Numbers  ICMJE AC-055E201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kelly Papadakis, MD Actelion
PRS Account Actelion
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP