Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
NCT ID: NCT02021292
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2014-08-20
2016-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Placebo
Matching placebo oral tablet, to be taken once daily.
Placebo
Matching placebo oral tablet, to be taken once daily.
Interventions
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Macitentan
Macitentan 10 mg, oral tablet, to be taken once daily.
Placebo
Matching placebo oral tablet, to be taken once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
84 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Kelly Papadakis, MD
Role: STUDY_CHAIR
Actelion
Locations
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University Hospital Gasthuisberg / Interne Geneeskunde - I.G. Pneumologie
Leuven, , Belgium
Beijing Chao-Yang Hospital-Department of Respiration
Beijing, , China
Cardiovascular institute & Fuwai Hospital- Thrombus Center
Beijing, , China
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, , China
ngShanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, , China
The General Hospital of Shenyang Military Region,Congenital Heart Disease Department
Shenyang, , China
Wuhan Asia Heart Hospital
Wuhan, , China
Centre for PPH, Charles University , II Interni klinika1.LF a VFN
Prague, , Czechia
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Européen Georges Pompidou Service de Pneumologie, soins intensifs et endoscopies bronchiques
Paris, , France
CHU de Toulouse Hopital Larrey
Toulouse, , France
Justus-Liebig-Universität Gießen
Giessen, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Missionsärztliche Klinik gGmbH Akademisches Lehrkrankenhaus der Julius-Maximilians-Universität
Würzburg, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Kardiológiai Klinika
Debrecen, , Hungary
Lietuvos Sveikatos Mokslų Universiteto Ligoninės Kauno Klinikos Pulmonologijos-Imunologijos Klinika
Kaunas, , Lithuania
Instituto Nacional de Cardiologia (INC) Ignacio Chavez
Mexico City, , Mexico
Wojewódzki Szpital Specjalistyczny w Lublinie im. Stefana Kardynała Wyszyńskiego SPZOZ Oddział Kardiologii - Pododdział Intensywnego Nadzoru Kardiologicznego
Lublin, , Poland
Wojewódzki Szpital Specjalistyczny we Wrocawiu
Wrocaw, , Poland
Federal State Budgetary Institution "Scientific Research Institute of Systemic Problems of Cardiovascular Diseases", Siberian branch of RAMS
Kemerovo, , Russia
Federal State Budgetary Institution "Russian Cardiology Scientific and Production Complex" of the Ministry of Health Care of the Russian Federation
Moscow, , Russia
E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rosmedtechnology
Novosibirsk, , Russia
Federal State Institution "Federal center of Heart, Blood and Endocrinology named after V.A.Almazov Rosmedtekhnologies"
Saint Petersburg, , Russia
Federal State Budgetary Institution "Research Institute for Cardiology" of Siberian Branch under the Russian Academy of Medical Sciences / Cardiovascular Surgery Department
Tomsk, , Russia
Severance Hospital, YonSei University Health System
Seoul, , South Korea
University Hospital Zürich
Zurich, , Switzerland
King Chulalongkorn Memorial Hospital, Division of Respiratory and Respiratory Critical Care Medicine
Bangkok, , Thailand
Siriraj Hospital, Division of Respiratory Disease and Tuberculosis
Bangkok, , Thailand
MAHARAJ NAKORN CHIANG MAI HOSPITAL, Department of Internal Medicine
Chiang Mai, , Thailand
Istanbul University İstanbul Faculty Medicine Pulmonology Department
Capa_Istanbul, , Turkey (Türkiye)
State Institute of Phthisiology and Pulmonology n.a. F.G. Yanovskiy of AMS Ukraine
Kyiv, , Ukraine
Lviv Regional Clinical Hospital, Cardiosurgery Department
Lviv, , Ukraine
Papworth Hospital NHS Trust, Pulmonary Vascular Diseases Unit
Cambridge, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Pulmonary Vascular Medicine
Sheffield, , United Kingdom
Countries
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References
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Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais 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.
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.
Ghofrani HA, Simonneau G, D'Armini AM, Fedullo P, Howard LS, Jais 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. 2024 Apr;12(4):e21-e30. doi: 10.1016/S2213-2600(24)00027-4.
Other Identifiers
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AC-055E201
Identifier Type: -
Identifier Source: org_study_id
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