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| ID | Type | Description | Link |
|---|---|---|---|
| 67896062CTP3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-004131-24 | EudraCT Number |
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The Sponsor decided to stop the study for futility based on a recommendation by the IDMC following a pre-planned interim analysis
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The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
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 endothelin receptor antagonist macitentan offers a different mode of action and addresses an important unmet medical need for an alternative treatment option in this indication. This study will assess the effect of macitentan 75 mg on exercise capacity in CTEPH. The total duration of the study is approximately 6 years. The study comprises of a screening period (at least 14 days and up to 60 days), a double-blind (DB) treatment period (28 weeks [minimum duration] up to 3.5 years), an open-label (OL) extension period (starts at end-of-DB-treatment [EODBT] and will end for all participants 104 weeks after the last participant has completed DB Week 28). The DB period consists of an 8-week up-titration phase and a maintenance phase. The maintenance phase is divided into a 28-week fixed duration part, at the end of which primary endpoint is assessed, and a variable duration part. The duration of the DB period for an individual participant depends on the timepoint of entry into the study and whether a CEC-confirmed clinical worsening event occurred. Participants who discontinue DB study intervention during the 28-week fixed duration part will be followed until Week 28 in a post-treatment observation period (PTOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macitentan | Experimental | Participant will receive macitentan at a dose of 10 milligram (mg) once daily (OD) for 4 weeks, followed by a dose of macitentan 37.5 mg for another 4 weeks and continue with the target dose of macitentan 75 mg. Participants who have reached the target dose of 75 mg, completed the Double-blind (DB) period up to Week 28 (either on treatment or in Post-treatment observation period [PTOP]) at minimum, may be eligible for transitioning into the Open label (OL) extension period once all participants have completed the DB part of the study, or earlier if they experienced a Clinical event committee (CEC) confirmed clinical worsening event. |
|
| Placebo | Experimental | Participants will receive placebo tablets matching the macitentan 10 mg, macitentan 37.5mg and macitentan 75 mg tablets, respectively. Participants who completed the DB period as per protocol either on treatment or in PTOP are eligible for transitioning to the OL extension period and will receive macitentan 75 mg after an 8-week double-dummy uptitration (macitentan 10 mg for 4 weeks, followed by 37.5 mg for another 4 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macitentan | Drug | Participants will receive Macitentan film-coated tablets orally od. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance (6MWD) at Week 28 | Change from baseline in 6MWD as measured by 6-minute walk test (6MWT) at Week 28 was reported. The purpose of the 6MWT was to quantify exercise tolerance and capacity. This standardized test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes. | Baseline (Day 1), Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Clinical Event Committee (CEC) Confirmed Clinical Worsening up to End-of Double-blind-treatment (EODBT) Period | Time (months) to first CEC-confirmed clinical worsening up to EODBT were reported. Clinical worsening was defined as the occurrence of at least one of the following events: 1) All-cause death; 2) Heart and/or lung transplantation; 3) Unplanned pulmonary hypertension (PH)-related hospitalization; 4) PH-related deterioration from baseline identified by at least one of the following: a) Persistent increase in World Health Organization functional class (WHO FC) that could not be explained by another cause (for example, viral infection); b) Persistent deterioration by at least 15 percent (%) in exercise capacity; as measured by the 6MWD; c) New or worsened signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Actelion Clinical Trial | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Center | La Jolla | California | 92037 | United States | ||
| Keck School of Medicine of USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38945473 | Derived | Inacio Cazeiro D, Azaredo Raposo M, Guimaraes T, Lousada N, Jenkins D, R Inacio J, Moreira S, Mineiro A, Freitas C, Martins S, Ferreira R, Luis R, Cardim N, Pinto FJ, Placido R. Chronic thromboembolic pulmonary hypertension: A comprehensive review of pathogenesis, diagnosis, and treatment strategies. Rev Port Cardiol. 2025 Feb;44(2):121-137. doi: 10.1016/j.repc.2024.04.006. Epub 2024 Jun 28. English, Portuguese. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Study comprised of screening, double-blind (DB), open-label (OL) and safety follow-up (FU) periods. The DB period started with an 8-week up-titration phase and lasted until all participants either completed the Week 28 visit or prematurely discontinued the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Blind (DB) Period: Macitentan | During the 8-week up-titration phase, participants received macitentan doses orally once daily (QD): 10 mg tablet for 4 weeks followed by 37.5 mg tablet for another 4 weeks prior to reaching the target maintenance phase dose of macitentan 75 mg QD. Participants were to remain on double-blind maintenance treatment until the last participant randomized completed the Week 28 visit. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter post-treatment observation period (PTOP) from DB period last dose until Week 28. Median exposure to DB treatment was 24.50 weeks (minimum: 3.9 weeks; maximum: 160.4 weeks). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DB Period: Day 1 up to EODBT |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2020 | Dec 20, 2024 |
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| Placebo | Drug | Participant will receive matching placebo tablets orally od. |
|
| From Baseline (Day 1) up to EODBT: median 24.5 weeks (min 3.9 weeks; max 160.4 weeks) for macitentan, median 44 weeks (min 4 weeks; max 147.9 weeks) for placebo |
| Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28 | Number of participants with improvement in WHO FC from baseline to Week 28 were reported. Improvement (decrease) in WHO FC from baseline to Week 28 was calculated for each participant. WHO FC test was used to assess disease severity. Four functional classes (FC) were defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). For the analysis purpose, these WHO FC class values were transformed to a scale with scores ranged from 1 to 4; where a score of 1 corresponded to WHO FC Class I and a score of 4 corresponded to WHO FC Class IV. The higher scores indicate greater symptom severity or worse impact. Improvement was considered when a participant changed from a higher class to a lower class. | From Baseline (Day 1) up to Week 28 |
| Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score | The cardiopulmonary symptoms domain consisted of 6 items: shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough and were reported on a 5-point Likert scale from 0 (no symptom at all) to 4 (very severe symptoms), with higher score indicating more symptom. The symptoms part of the PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms. A higher score indicated more severe symptoms experienced. | From Baseline (Day 1) up to Week 28 |
| Change From Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score | The cardiovascular symptoms domain consisted of 5 items: heart palpitations (fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness and were reported on a 5-point Likert scale ranged from 0 (no symptoms at al) to 4 (very severe symptoms), with high score indicating more symptom. The symptoms part of PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. An average Cardiovascular Symptoms domain score was determined based on the daily scores of the 5 items. The mean individual symptom item score was determined for each of the 5 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiovascular symptoms to 4=severe cardiovascular symptoms. Higher score indicated more severe symptoms experienced. | From Baseline (Day 1) up to Week 28 |
| Change From Baseline to Week 28 in Euro Quality of Life-5-Dimension-5-Level (EQ-5D-5L) Utility Score and Visual Analog Scale (VAS) Score | The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L consisted of 2 parts: EQ-5D-5L utility score (descriptive system) and VAS score. EQ-5D-5L descriptive system consisted of 5-item questionnaire that assessed 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each questionnaire had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 questionnaires were used to compute a single utility score which ranged from 0 to 1, where higher score indicated better health state and lower score indicated worse health state. EQ-5D-5L VAS rated current health state on a vertical scale with a score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), higher scores indicated a better health state. | From Baseline (Day 1) up to Week 28 |
| Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity | Change from baseline to Week 28 in accelerometer-assessed proportion of time spent in moderate to vigorous physical activity were assessed. Daily life physical activity of participant was assessed using accelerometer which was provided to the participant at screening and was worn daily during waking hours up to Week 28. For each scheduled visit, the 14 days prior to the visit were considered as the assessment period for physical activity. To be considered evaluable for a given timepoint, actigraphy variables should have been measured for at least 7 complete days (consecutive or not). A complete day is defined as a record of at least 7 waking hours of data. Proportion of time spent in moderate to vigorous physical activity was the estimated number of minutes spent in moderate or higher physical activity as calculated using the Staudenmayer '15 technique as proportion of the total minutes of algorithmically detected wear time and excluding the minutes that fall within a sleep period. | From Baseline (Day 1) up to Week 28 |
| Los Angeles |
| California |
| 90033 |
| United States |
| UC Davis Medical Center | Sacramento | California | 95817-2201 | United States |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06519 | United States |
| University of Florida Health Jacksonville | Gainesville | Florida | 32608 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Tufts Medical Center | Boston | Massachusetts | 21118 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-2265 | United States |
| VA Sierra Nevada Health Care System | Reno | Nevada | 89509 | United States |
| University of New Mexico School of Medicine | Albuquerque | New Mexico | 87131 | United States |
| Syracuse VA Medical Center | Syracuse | New York | 13210 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Legacy Hospital | Portland | Oregon | 97210 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Baylor Scott White - Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Utah Cardiovascular Center | Salt Lake City | Utah | 84132 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792-2442 | United States |
| Nexo Salud Investigacion Clinica | Buenos Aires | C1006ACC | Argentina |
| Sanatorio de la Trinidad Mitre | Buenos Aires | C1039AAO | Argentina |
| Sanatorio Guemes | C.a.b.a. | C1180AAX | Argentina |
| Queensland Lung Transplant Service | Chermside | 4032 | Australia |
| St Vincent's hospital | Darlinghurst | 2010 | Australia |
| LKH-Univ. Klinikum Graz | Graz | 8036 | Austria |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | 4020 | Austria |
| Medizinische Universitaet Wien | Vienna | 1090 | Austria |
| Military Medical Academy | Sofia | 1606 | Bulgaria |
| University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD | Sofia | 1750 | Bulgaria |
| University Of Calgary - Peter Lougheed Centre | Calgary | Alberta | T1Y 6J4 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| Beijing Chaoyang Hospital | Beijing | 100020 | China |
| Beijing Anzhen Hospital | Beijing | 100029 | China |
| China Japan Friendship Hospital | Beijing | 100029 | China |
| Beijing Shijitan Hospital | Beijing | 100038 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510140 | China |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | 310016 | China |
| Zhongda Hospital Southeast University | Nanjing | 210009 | China |
| The Affiliated Hospital of Medical College Qingdao University | Qingdao | 266003 | China |
| Huashan Hospital of Fudan University | Shanghai | 200040 | China |
| Shanghai Pulmonary Hospital | Shanghai | 200433 | China |
| Zhongshan Hospital Fudan University | Shanghai | China |
| The General Hospital of Northern Theater Command | Shenyang | 110000 | China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | 710061 | China |
| Fundacion Neumologica Colombiana | Bogotá | 1101131 | Colombia |
| Fundación Abood Shaio | Bogotá | 85369 | Colombia |
| Clínica Imbanaco S.A.S. | Cali | 760042 | Colombia |
| Centro Cardiovascular Colombiano Clínica Santa María | Medellín | 681004 | Colombia |
| General University Hospital II.department of Internal Medicine-cardiology and angiology | Prague | 128 08 | Czechia |
| Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B | Aarhus N | 8200 | Denmark |
| CHU de Brest - Hopital de la Cavale Blanche | Brest | 29200 | France |
| CHU de Grenoble Hopital Albert Michallon | Grenoble | 38043 | France |
| Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Cardiologique - Chru Lille | Lille | 59037 | France |
| CHU de Montpellier - Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42277 | France |
| Hopital Larrey CHU de Toulouse | Toulouse | France |
| CHU de Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Universitatsklinikum Bonn | Bonn | 53127 | Germany |
| Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden | Dresden | 01307 | Germany |
| Universitaetsklinikum Giessen | Giessen | 35392 | Germany |
| Universitaetsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie | Hanover | 30625 | Germany |
| Thoraxklinik Heidelberg | Heidelberg | 69126 | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | 66421 | Germany |
| Universitatsklinikum Jena | Jena | 07747 | Germany |
| Krankenhaus Neuwittelsbach | München | 80639 | Germany |
| Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly | Budapest | 1096 | Hungary |
| Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő | Szeged | 6720 | Hungary |
| Tel Aviv Medical Center | Tel Aviv | 6423906 | Israel |
| The Chaim Sheba Medical Center | Tel Litwinsky | 5265601 | Israel |
| Ospedale SS. Annunziata | Chieti | 66100 | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Fondazione Toscana Gabriele Monasterio CNR | Pisa | 56124 | Italy |
| Policlinico Gemelli Universita Cattolica | Roma | 00168 | Italy |
| A.O.U. Città della Salute e della Scienza | Torino | 10126 | Italy |
| The University of Tokyo Hospital | Bunkyō City | 113-8655 | Japan |
| Kyushu University Hospital | Fukuoka | 812 8582 | Japan |
| Kure Kyosai Hospital | Hiroshima | 737-8505 | Japan |
| St Marianna University Hospital | Kanagawa | 216 8511 | Japan |
| Kobe University Hospital | Kobe | 650 0017 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Kyoto University Hospital | Kyoto | 606 8507 | Japan |
| Shinshu University Hospital | Matsumoto | 390 8621 | Japan |
| Toho University Medical Center, Ohashi Hospital | Meguro-ku | 153-8515 | Japan |
| Kyorin University Hospital | Mitaka | 181-8611 | Japan |
| Nagoya University Hospital | Nagoya | 466 8560 | Japan |
| National Hospital Organization Okayama Medical Center | Okayama | 701-1192 | Japan |
| Hokkaido University Hospital | Sapporo | 060-8648 | Japan |
| National Cerebral and Cardiovascular Center | Suita-Shi | 564-8565 | Japan |
| Juntendo University Hospital | Tokyo | 113-8431 | Japan |
| University of Tsukuba Hospital | Tsukuba | 305 8576 | Japan |
| Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas | 50161 | Lithuania |
| Vilnius University Hospital Santariskiu Klinikos | Vilnius | LT-08661 | Lithuania |
| Instituto Nacional de Cardiologia Dr. Ignacio Chavez | Mexico City | 14080 | Mexico |
| Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas | México | 52787 | Mexico |
| Unidad de Investigacion Clinica en Medicina S.C. (UDICEM) | Monterrey | 64718 | Mexico |
| Centro de Investigacion Clinica Chapultepec | Morelia | 58260 | Mexico |
| CRI Centro Regiomontano de Investigacion SC | Nuevo León | 64060 | Mexico |
| Krakowski Szpital Specjalistyczny im Jana Pawla II | Krakow | 31 202 | Poland |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego PZOZ | Lublin | 20 708 | Poland |
| Europejskie Centrum Zdrowia Otwock Sp z o o | Otwock | 05 400 | Poland |
| Uls Almada Seixal - Hosp. Garcia de Orta | Almada | 2805 267 | Portugal |
| Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu | Bucharest | 022328 | Romania |
| Spitalul Clinic Judetean de Urgenta | Tg. Mures | 540136 | Romania |
| State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center' | Kazan' | 420101 | Russia |
| Moscow City Clinical Hospital No.51 | Moscow | 121309 | Russia |
| National Medical Research Center of Cardiology of MoH of Russian Federation | Moscow | 121552 | Russia |
| National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation | Saint Petersburg | 197341 | Russia |
| Volgograd Regional Clinical Cardiology Center | Volgograd | 400008 | Russia |
| King Faisal Specialist Hospital & Research Center | Riyadh | 12713 | Saudi Arabia |
| King Fahad Medical City | Riyadh | 59046 | Saudi Arabia |
| University Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Institute for Pulmonary Disease of Vojvodina | Kamenitz | 21204 | Serbia |
| National University Heart Centre, Singapore | Singapore | 119228 | Singapore |
| National Heart Centre (NHC) Singapore | Singapore | 169609 | Singapore |
| Narodny ustav srdcovych a cievnych chorob | Bratislava | 833 48 | Slovakia |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | 06591 | South Korea |
| Hosp Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp Virgen de La Victoria | Málaga | 29010 | Spain |
| Hosp. Costa Del Sol | Málaga | 29603 | Spain |
| Hosp. Gral. Univ. de Toledo | Toledo | 45007 | Spain |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 813 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | 333 | Taiwan |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Thammasat Hospital | Pathum Thani | 12120 | Thailand |
| Adana City Hospital | Adana | 01170 | Turkey (Türkiye) |
| Cukurova University Medical Faculty | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty | Ankara | 06230 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Ankara | 06800 | Turkey (Türkiye) |
| Pamukkale University Medical Faculty | Denizli | 20070 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Medical Faculty Hospital | Eskişehir | 26040 | Turkey (Türkiye) |
| Istanbul University - Cerrahpasa Cardiology Institution | Istanbul | 34096 | Turkey (Türkiye) |
| Siyami Ersek Training and Research Hospital | Istanbul | 34668 | Turkey (Türkiye) |
| Marmara University Medical Faculty | Istanbul | 34899 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
| Dokuz Eylul University Medical Faculty | Izmir | 35340 | Turkey (Türkiye) |
| Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi | Kartal Istanbul | 34865 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Mersin | 33110 | Turkey (Türkiye) |
| CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council' | Cherkasy | 18009 | Ukraine |
| CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery' | Dnipro | 49059 | Ukraine |
| SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine | Kyiv | 02000 | Ukraine |
| State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine | Kyiv | 03680 | Ukraine |
| Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv | 79010 | Ukraine |
| Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council | Ternopil | 46002 | Ukraine |
| Papworth Hospital NHS Trust | Cambridge | CB2 0AY | United Kingdom |
| National Waiting Times Centre Board Golden Jubilee National Hospital | Glasgow | G81 4DY | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital | Sheffield | S10 2RX | United Kingdom |
| FG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
| FG002 | Open Label (OL) Period: DB Macitentan | Participants who were treated with macitentan in the DB period and had reached the target dose of macitentan 75 mg and completed the DB period as per protocol were considered eligible to transition into the 104-week OL period and they continued macitentan 75 mg tablet orally QD from end of double blind treatment (EODBT) until study termination. Participants who experienced a clinical worsening event confirmed by the clinical event committee (CEC), were allowed to transition to the OL period at any time after Week 28. Median exposure to OL treatment was 72 weeks (minimum: 8.1 weeks; maximum: 84.6 weeks). |
| FG003 | OL Period: DB Placebo | Participants who were treated with placebo in the DB period and had completed the DB period as per protocol were considered eligible to transition into the 104-week OL period and were up-titrated to the target dose of macitentan 75 mg (macitentan 10 mg for 4 weeks, followed by macitentan 37.5 mg for another 4 weeks). Participants who experienced a clinical worsening event confirmed by the CEC, were allowed to transition to the OL period at any time after Week 28. Median exposure to OL treatment was 72 weeks (minimum: 8.1 weeks; maximum: 84.6 weeks). |
| COMPLETED |
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| NOT COMPLETED |
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|
| OL Period:Day 1 Upto End of OL Treatment |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double Blind (DB) Period: Macitentan | During the 8-week up-titration phase, participants received macitentan doses orally once daily (QD): 10 mg tablet for 4 weeks followed by 37.5 mg tablet for another 4 weeks prior to reaching the target maintenance phase dose of macitentan 75 mg QD. Participants were to remain on double-blind maintenance treatment until the last participant randomized completed the Week 28 visit. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter post-treatment observation period (PTOP) from DB period last dose until Week 28. Median exposure to DB treatment was 24.50 weeks (minimum: 3.9 weeks; maximum: 160.4 weeks). |
| BG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| AgeContinuous | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in 6-minute Walk Distance (6MWD) at Week 28 | Change from baseline in 6MWD as measured by 6-minute walk test (6MWT) at Week 28 was reported. The purpose of the 6MWT was to quantify exercise tolerance and capacity. This standardized test measured the distance an individual was able to walk over a total of six minutes on a hard, flat surface with no obstacles. The goal was for the individual to walk as far as possible in 6 minutes. | Full analysis set (FAS) included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via interactive web response system (IWRS). Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | Meters | Baseline (Day 1), Week 28 |
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| Secondary | Time to First Clinical Event Committee (CEC) Confirmed Clinical Worsening up to End-of Double-blind-treatment (EODBT) Period | Time (months) to first CEC-confirmed clinical worsening up to EODBT were reported. Clinical worsening was defined as the occurrence of at least one of the following events: 1) All-cause death; 2) Heart and/or lung transplantation; 3) Unplanned pulmonary hypertension (PH)-related hospitalization; 4) PH-related deterioration from baseline identified by at least one of the following: a) Persistent increase in World Health Organization functional class (WHO FC) that could not be explained by another cause (for example, viral infection); b) Persistent deterioration by at least 15 percent (%) in exercise capacity; as measured by the 6MWD; c) New or worsened signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. | Posted | Median | 95% Confidence Interval | Months | From Baseline (Day 1) up to EODBT: median 24.5 weeks (min 3.9 weeks; max 160.4 weeks) for macitentan, median 44 weeks (min 4 weeks; max 147.9 weeks) for placebo |
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| Secondary | Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28 | Number of participants with improvement in WHO FC from baseline to Week 28 were reported. Improvement (decrease) in WHO FC from baseline to Week 28 was calculated for each participant. WHO FC test was used to assess disease severity. Four functional classes (FC) were defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). For the analysis purpose, these WHO FC class values were transformed to a scale with scores ranged from 1 to 4; where a score of 1 corresponded to WHO FC Class I and a score of 4 corresponded to WHO FC Class IV. The higher scores indicate greater symptom severity or worse impact. Improvement was considered when a participant changed from a higher class to a lower class. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Baseline (Day 1) up to Week 28 |
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| Secondary | Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms and Impact (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score | The cardiopulmonary symptoms domain consisted of 6 items: shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough and were reported on a 5-point Likert scale from 0 (no symptom at all) to 4 (very severe symptoms), with higher score indicating more symptom. The symptoms part of the PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. The mean individual symptom item score was determined for each of the 6 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiopulmonary symptoms to 4=severe cardiopulmonary symptoms. A higher score indicated more severe symptoms experienced. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | From Baseline (Day 1) up to Week 28 |
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| Secondary | Change From Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score | The cardiovascular symptoms domain consisted of 5 items: heart palpitations (fluttering), rapid heartbeat, chest pain, chest tightness, and lightheadedness and were reported on a 5-point Likert scale ranged from 0 (no symptoms at al) to 4 (very severe symptoms), with high score indicating more symptom. The symptoms part of PAH-SYMPACT was administered daily over a 7-day period. The recall period of symptom items was the last 24 hours. An average Cardiovascular Symptoms domain score was determined based on the daily scores of the 5 items. The mean individual symptom item score was determined for each of the 5 items and a domain score was calculated by summing the mean individual symptom item scores and dividing by the number of items, ranged from 0=no cardiovascular symptoms to 4=severe cardiovascular symptoms. Higher score indicated more severe symptoms experienced. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | From Baseline (Day 1) up to Week 28 |
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| Secondary | Change From Baseline to Week 28 in Euro Quality of Life-5-Dimension-5-Level (EQ-5D-5L) Utility Score and Visual Analog Scale (VAS) Score | The EQ-5D-5L was a generic measure of health status. The EQ-5D-5L consisted of 2 parts: EQ-5D-5L utility score (descriptive system) and VAS score. EQ-5D-5L descriptive system consisted of 5-item questionnaire that assessed 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each questionnaire had 5 response levels: 1 =no problems, 2 =slight problems, 3 =moderate problems, 4 =severe problems and 5 =extreme problems. The scores for the 5 questionnaires were used to compute a single utility score which ranged from 0 to 1, where higher score indicated better health state and lower score indicated worse health state. EQ-5D-5L VAS rated current health state on a vertical scale with a score ranged from 0 (worst imaginable health state) to 100 (best imaginable health state), higher scores indicated a better health state. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | From Baseline (Day 1) up to Week 28 |
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| Secondary | Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity | Change from baseline to Week 28 in accelerometer-assessed proportion of time spent in moderate to vigorous physical activity were assessed. Daily life physical activity of participant was assessed using accelerometer which was provided to the participant at screening and was worn daily during waking hours up to Week 28. For each scheduled visit, the 14 days prior to the visit were considered as the assessment period for physical activity. To be considered evaluable for a given timepoint, actigraphy variables should have been measured for at least 7 complete days (consecutive or not). A complete day is defined as a record of at least 7 waking hours of data. Proportion of time spent in moderate to vigorous physical activity was the estimated number of minutes spent in moderate or higher physical activity as calculated using the Staudenmayer '15 technique as proportion of the total minutes of algorithmically detected wear time and excluding the minutes that fall within a sleep period. | FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percent of minutes per day | From Baseline (Day 1) up to Week 28 |
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DB period:DB Day 1 to 30 days post EODBT (median exposure[ME]:24.5 weeks[wks], [min 3.9 wks; max 160.4 wks] on macitentan, ME:44 wks [min 4 wks; max 147.9 wks] on placebo); OL period: OL Day 1 to study termination (ME:72 wks [min 8.1 wks; max 84.6 wks]).
Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention in this study and were analysed according to the intervention they actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind (DB) Period: Macitentan | During the 8-week up-titration phase, participants received macitentan doses orally once daily (QD): 10 mg tablet for 4 weeks followed by 37.5 mg tablet for another 4 weeks prior to reaching the target maintenance phase dose of macitentan 75 mg QD. Participants were to remain on double-blind maintenance treatment until the last participant randomized completed the Week 28 visit. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter post-treatment observation period (PTOP) from DB period last dose until Week 28. Median exposure to DB treatment was 24.50 weeks (minimum: 3.9 weeks; maximum: 160.4 weeks). | 1 | 64 | 17 | 64 | 47 | 64 |
| EG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). | 0 | 63 | 14 | 63 | 38 | 63 |
| EG002 | Open Label (OL) Period: DB Macitentan | Participants who were treated with macitentan in the DB period and had reached the target dose of macitentan 75 mg and completed the DB period as per protocol were considered eligible to transition into the 104-week OL period and they continued macitentan 75 mg tablet orally QD from EODBT until study termination. Participants who experienced a clinical worsening event confirmed by the CEC, were allowed to transition to the OL period at any time after Week 28. Median exposure to OL treatment was 72 weeks (minimum: 8.1 weeks; maximum: 84.6 weeks). | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | OL Period: DB Placebo | Participants who were treated with placebo in the DB period and had completed the DB period as per protocol were considered eligible to transition into the 104-week OL period and were up-titrated to the target dose of macitentan 75 mg (macitentan 10 mg for 4 weeks, followed by macitentan 37.5 mg for another 4 weeks). Participants who experienced a clinical worsening event confirmed by the CEC, were allowed to transition to the OL period at any time after Week 28. Median exposure to OL treatment was 72 weeks (minimum: 8.1 weeks; maximum: 84.6 weeks). | 0 | 6 | 4 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis Coronary Artery | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Atrial Tachycardia | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Right Ventricular Failure | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Sinus Node Dysfunction | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Vertigo Positional | Ear and labyrinth disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cataract | Eye disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Dental Caries | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Diverticulum Intestinal Haemorrhagic | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Large Intestine Polyp | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Postoperative Hypertension | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Lumbar Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Renal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hemiparesis | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Urge Incontinence | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Abnormal Uterine Bleeding | Reproductive system and breast disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Organising Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Ovarian Cystectomy | Surgical and medical procedures | MedDRA Version 26.1 | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Post Thrombotic Syndrome | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Iron Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Swelling | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
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| Haemoglobin Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
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| Fluid Retention | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Iron Deficiency | Metabolism and nutrition disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Memory Impairment | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA Version 26.1 | Non-systematic Assessment |
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Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Science Director CP | Actelion Pharmaceuticals Ltd | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2024 | Dec 20, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C533860 | macitentan |
Not provided
Not provided
Not provided
| Other |
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| Over 75 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| AUSTRALIA |
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| BULGARIA |
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| CHINA |
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| CZECH REPUBLIC |
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| DENMARK |
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| FRANCE |
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| GERMANY |
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| HUNGARY |
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| ISRAEL |
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| ITALY |
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| JAPAN |
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| LITHUANIA |
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| MEXICO |
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| POLAND |
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| PORTUGAL |
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| ROMANIA |
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| RUSSIAN FEDERATION |
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| SAUDI ARABIA |
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| SINGAPORE |
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| SLOVAKIA |
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| SOUTH KOREA |
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| SPAIN |
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| TAIWAN |
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| THAILAND |
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| TURKEY |
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| UNITED KINGDOM |
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| UNITED STATES |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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| OG001 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). |
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