Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT ID: NCT02060721
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2015-02-03
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Macitentan
Macitentan 10mg, oral tablet, once daily
Macitentan
Macitentan 10mg, oral tablet, once daily
Interventions
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Macitentan
Macitentan 10mg, oral tablet, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Erin McGuire
Role: STUDY_DIRECTOR
Actelion
Locations
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Leuven, , Belgium
Beijing, , China
Guangzhou, , China
Shanghai, , China
Shenyang, , China
Wuhan, , China
Prague, , Czechia
Le Kremlin-Bicêtre, , France
Paris, , France
Toulouse, , France
Giessen, , Germany
Heidelberg, , Germany
Würzburg, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Kaunas, , Lithuania
Mexico City, , Mexico
Lublin, , Poland
Wroclaw, , Poland
Kemerovo, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Zurich, , Switzerland
Bangkok, , Thailand
Chiang Mai, , Thailand
Capa_Istanbul, , Turkey (Türkiye)
Kyiv, , Ukraine
Lviv, , Ukraine
Cambridge, , United Kingdom
London, , United Kingdom
Sheffield, , United Kingdom
Countries
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References
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Kim NH, D'Armini AM, Howard LS, Jenkins DP, Jing ZC, Mayer E, Chamitava L, Lack G, Rofael H, Solonets M, Ghofrani HA. Long-Term Safety and Efficacy of Macitentan in Inoperable Chronic Thromboembolic Pulmonary Hypertension: Results from MERIT and its Open-Label Extension. Pulm Ther. 2025 Mar;11(1):101-116. doi: 10.1007/s41030-024-00276-w. Epub 2024 Nov 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-003457-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-055E202
Identifier Type: -
Identifier Source: org_study_id
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