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Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (MERIT-2)

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ClinicalTrials.gov Identifier: NCT02060721
Recruitment Status : Active, not recruiting
First Posted : February 12, 2014
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE January 2, 2014
First Posted Date  ICMJE February 12, 2014
Last Update Posted Date September 1, 2021
Actual Study Start Date  ICMJE February 3, 2015
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2015)
  • Treatment-emergent adverse events (AEs) up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • AEs leading to premature discontinuation of study drug. [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Treatment-emergent serious adverse events up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Treatment-emergent marked laboratory abnormalities up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation (up to 24 months from Visit 1) ]
  • Change in vital signs (arterial blood pressure, heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 24 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
AEs during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change from baseline to each scheduled time point in exercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
  • Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
  • Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
  • marked laboratory abnormalities during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
  • Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2015)
  • Change from baseline to each scheduled time point inexercise capacity, as measured by the 6MWD [ Time Frame: Baseline up to 30 months ]
  • Change from baseline to each scheduled time point in Borg dyspnea index [ Time Frame: Baseline up to 30 months ]
  • Proportion of subjects with worsening of WHO FC from baseline to each scheduled time point. [ Time Frame: Baseline up to 30 months ]
  • marked laboratory abnormalities during treatment period and up to 30 days after study drug discontinuation [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
  • Change in vital signs (blood pressure , heart rate) and body weight from baseline to all assessed time points during the study [ Time Frame: From baseline up to 30 days after study drug discontinuation. ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Official Title  ICMJE 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)
Brief Summary 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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Thromboembolic Pulmonary Hypertension
Intervention  ICMJE Drug: Macitentan
Macitentan 10mg, oral tablet, once daily
Other Name: ACT-064992
Study Arms  ICMJE Experimental: Macitentan
Macitentan 10mg, oral tablet, once daily
Intervention: Drug: Macitentan
Publications * Not Provided

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
76
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
78
Estimated Study Completion Date  ICMJE December 22, 2021
Estimated Primary Completion Date December 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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,   Lithuania,   Mexico,   Poland,   Russian Federation,   Switzerland,   Thailand,   Turkey,   Ukraine,   United Kingdom
Removed Location Countries Austria,   Bulgaria,   Canada,   Chile,   Czech Republic,   Italy,   Korea, Republic of,   Netherlands,   South Africa,   United States,   Vietnam
 
Administrative Information
NCT Number  ICMJE NCT02060721
Other Study ID Numbers  ICMJE AC-055E202
2013-003457-25 ( EudraCT Number )
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 Director: Erin McGuire Actelion
PRS Account Actelion
Verification Date August 2021

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