A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Launched by ACTELION · Feb 13, 2020
Trial Information
Current as of July 21, 2025
Terminated
Keywords
ClinConnect Summary
CTEPH is one of the leading causes of severe pulmonary hypertension (PH), classified within World Health Organization (WHO) group 4 PH. It is a rare, progressive pulmonary vascular disease that if left untreated, leads to progressively increasing pulmonary vascular resistance (PVR) and eventually right ventricle failure and death. Histopathologic findings including endothelial cell dysfunction and distal pulmonary arterial remodeling are shared between PAH and CTEPH, and PH-specific therapies (that is, riociguat) have shown efficacy in inoperable and persistent/recurrent CTEPH. The endothel...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization \[WHO\] Group 4) fulfilling one of the following criteria: a) inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), b) persistent/recurrent CTEPH after balloon pulmonary angioplasty (BPA), and deemed inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), c) persistent/recurrent CTEPH after rescue pulmonary endarterectomy (PEA)
- • 6-minute walk distance (6MWD) greater than or equal to (\>=) 100 meter (m) and less than or equal to (\<=) 450 meters (m), documented by an eligibility and a baseline 6-minute walk test (6MWT). The baseline 6MWD must not differ by more than 15 percent (%) from the eligibility test
- • World Health Organization functional class (WHO FC) \>= II
- • Participants are to receive riociguat as per local standard of care, unless it is contraindicated or unavailable
- Exclusion Criteria:
- • Acute pulmonary embolism within 3 months prior to or during Screening
- • Planned balloon pulmonary angioplasty (BPA) during the fixed duration part of the double-blind period
- • Significant obstructive and restrictive lung disease
- • Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements, in particular with 6MWT (for example, intermittent claudication).
- • Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the fixed duration part of the study
- • Decompensated cardiac failure if not under close supervision
- • Known and documented life-threatening cardiac arrhythmias
- • Acute myocardial infarction within 6 months prior to, or during Screening
- • Cerebrovascular events (including transient ischemic attack) within 3 months prior to, or during Screening
- • Known or suspicion of pulmonary veno-occlusive disease (PVOD)
- • Administration of ERAs, intravenous prostacyclins / prostacyclin analogs, or investigational treatment within 90 days prior to Randomization
- • Change in dose or initiation of Phosphodiesterase type-5 (PDE-5) inhibitors, oral, inhaled or subcutaneous (SC) prostacyclins / prostacyclin analogues, prostacyclin receptor agonists or riociguat, a) within 90 days prior to Randomization, or b) anticipated during the fixed duration part of the double-blind \[DB\] period
- • Hypotension, that is, systolic blood pressure (SBP) less than (\<) 90 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) \<50 mmHg at Screening.
- • Severe renal dysfunction with an estimated Glomerular Filtration Rate \<30 milliliters per minute per 1.73 meter square (mL/min/1.73 m\^2) using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening
- • Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
- • Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (\>=) 1.5\*upper limit of normal (ULN) at Screening
- • Hemoglobin \<100 g/L (\<10 gram per deciliter \[g/dL\]) at Screening
About Actelion
Actelion, a biopharmaceutical company, specializes in the development and commercialization of innovative therapies for pulmonary arterial hypertension and other serious conditions. Established in 1997 and now a part of Johnson & Johnson, Actelion is committed to advancing medical science through rigorous clinical trials and research initiatives. With a focus on improving patient outcomes, the company leverages cutting-edge science and technology to deliver breakthrough treatments that address unmet medical needs, demonstrating a strong dedication to enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Baltimore, Maryland, United States
Edmonton, Alberta, Canada
Albuquerque, New Mexico, United States
Pittsburgh, Pennsylvania, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Tucson, Arizona, United States
London, , United Kingdom
Chicago, Illinois, United States
Louisville, Kentucky, United States
Heidelberg, , Germany
Syracuse, New York, United States
Homburg, , Germany
Qingdao, , China
Kyoto, , Japan
Murray, Utah, United States
Kaohsiung, , Taiwan
New Haven, Connecticut, United States
Omaha, Nebraska, United States
Haifa, , Israel
London, , United Kingdom
Beijing, , China
Seoul, , Korea, Republic Of
Taipei, , Taiwan
Taipei, , Taiwan
Gainesville, Florida, United States
Seoul, , Korea, Republic Of
Sofia, , Bulgaria
Seoul, , Korea, Republic Of
La Jolla, California, United States
Khon Kaen, , Thailand
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Toronto, Ontario, Canada
Beijing, , China
Pavia, , Italy
Kobe, , Japan
Matsumoto, , Japan
Beijing, , China
Hamburg, , Germany
Okayama, , Japan
Tokyo, , Japan
Singapore, , Singapore
Newcastle Upon Tyne, , United Kingdom
Shanghai, , China
Izmir, , Turkey
Jena, , Germany
Vienna, , Austria
Atlanta, Georgia, United States
Saint Louis, Missouri, United States
Vilnius, , Lithuania
Nanjing, , China
Chiang Mai, , Thailand
Regensburg, , Germany
Vienna, , Austria
Aurora, Colorado, United States
Graz, , Austria
Fukuoka, , Japan
C.A.B.A., , Argentina
Changsha, , China
Jena, , Germany
Wuhan, , China
Miami, Florida, United States
Seoul, , Korea, Republic Of
Nanjing, , China
Shanghai, , China
Peoria, Illinois, United States
Busan, , Korea, Republic Of
Shanghai, , China
Guangzhou, Guangdong, China
Beijing, Beijing, China
Aurora, Colorado, United States
Seoul, , Korea, Republic Of
Sapporo Shi, , Japan
Austell, Georgia, United States
Dresden, , Germany
Denizli, , Turkey
Kyiv, , Ukraine
Beijing, , China
Bonn, , Germany
Belgrade, , Serbia
Xi'an, , China
Chongqing, , China
Darlinghurst, , Australia
Ankara, , Turkey
Izmir, , Turkey
Madrid, , Spain
Málaga, , Spain
Sheffield, , United Kingdom
Ankara, , Turkey
Chelyabinsk, , Russian Federation
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Madrid, , Spain
Grenoble Cedex 9, , France
Barcelona, , Spain
Philadelphia, Pennsylvania, United States
Singapore, , Singapore
Mitaka, , Japan
Los Angeles, California, United States
Ciudad De México, , Mexico
Beijing, , China
Linz, , Austria
Kyoto, , Japan
Tel Aviv, , Israel
Xi'an, , China
Berlin, , Germany
Sofia, , Bulgaria
Praha 2, , Czechia
Giessen, , Germany
Bucuresti, , Romania
Moscow, , Russian Federation
Moscow, , Russian Federation
Taoyuan, , Taiwan
Istanbul, , Turkey
Seoul, , Korea, Republic Of
Torino, , Italy
Nanjing, , China
Nuevo Leon, , Mexico
Kyoto, , Japan
Tel Hashomer, , Israel
Reno, Nevada, United States
Lviv, , Ukraine
Lille Cedex, , France
Montpellier, , France
St Priest En Jarez Cedex, , France
Toulouse Cedex 9, , France
Vandoeuvre Les Nancy Cedex, , France
Wrocław, , Poland
Dnipro, , Ukraine
Guangzhou, , China
Hangzhou, , China
Jeddah, , Saudi Arabia
Budapest, , Hungary
Meguro Ku, , Japan
Riyadh, , Saudi Arabia
Mersin, , Turkey
Salt Lake City, Utah, United States
Buenos Aires, , Argentina
Chermside, , Australia
Calgary, Alberta, Canada
Shenyang, , China
Tian Jin, , China
Hannover, , Germany
Szeged, , Hungary
Monterrey, , Mexico
Moscow, , Russian Federation
Novosibirsk, , Russian Federation
Saint Petersburg, , Russian Federation
Bratislava, , Slovakia
Kartal Istanbul, , Turkey
Kyiv, , Ukraine
Cambridge, , United Kingdom
Glasgow, , United Kingdom
Chieti, , Italy
Almada, , Portugal
Malaga, , Spain
Toledo, , Spain
Portland, Oregon, United States
Plano, Texas, United States
Calgary, Alberta, Canada
Bunkyo, , Japan
Hiroshima, , Japan
Suita Shi, , Japan
Tsukuba City, , Japan
Istanbul, , Turkey
Sacramento, California, United States
Jacksonville, Florida, United States
Kanagawa, , Japan
Valladolid, , Spain
Dresden, , Germany
Mexico, , Mexico
Houston, Texas, United States
Brest, , France
Otwock, , Poland
Cherkasy, , Ukraine
Nagoya, Aiti, Japan
Boston, Massachusetts, United States
Portland, Oregon, United States
Knoxville, Tennessee, United States
Madison, Wisconsin, United States
Ciudad Autonoma De Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Nanjing, , China
Shanghai, , China
Shanghai, , China
Bogota, , Colombia
Bogota, , Colombia
Cali, , Colombia
Casanare, , Colombia
Medellin, , Colombia
Le Kremlin Bicetre Cedex, , France
München, , Germany
Pisa, , Italy
Roma, , Italy
Kaunas, , Lithuania
Morelia, , Mexico
Katowice, , Poland
Kraków, , Poland
Lublin, , Poland
Tg. Mures, , Romania
Kazan, , Russian Federation
Volgograd, , Russian Federation
Riyadh, , Saudi Arabia
Sremska Kamenica, , Serbia
Adana, , Turkey
Istanbul, , Turkey
Ternopil, , Ukraine
Vienna, , Austria
Adana, , Turkey
Suita Shi, , Japan
Gainesville, Florida, United States
Cali, , Colombia
Aarhus N, , Denmark
Grenoble Cedex 9, , France
Pathumthani, , Thailand
Eskisehir, , Turkey
Cali, , Colombia
Gainesville, Florida, United States
Ankara, , Turkey
Dresden, , Germany
Barcelona, , Spain
Vandoeuvre Les Nancy Cedex, , France
Kartal Istanbul, , Turkey
St Priest En Jarez Cedex, , France
Grenoble Cedex 9, , France
Bucuresti, , Romania
Budapest, , Hungary
St Priest En Jarez Cedex, , France
Kanagawa, , Japan
Tsukuba City, , Japan
Barcelona, , Spain
Brest, , France
Beijing, , China
Málaga, , Spain
Kobe, , Japan
Matsumoto, , Japan
Le Kremlin Bicetre Cedex, , France
Otwock, , Poland
Almada, , Portugal
Hangzhou, , China
Krakow, , Poland
Otwock, , Poland
Lublin, , Poland
Kyoto, , Japan
Patients applied
Trial Officials
Actelion Clinical Trial
Study Director
Actelion
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials