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A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension (MACiTEPH)

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macitentan
Placebo
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego Medical Center
  • Keck School of Medicine of USC
  • UC Davis Medical Center
  • University of Colorado - Anschutz Medical Campus
  • Yale University School Of Medicine
  • University of Florida Health Jacksonville
  • Piedmont Healthcare
  • Northwestern University Feinberg School of Medicine
  • Indiana University
  • University of Kansas Medical Center
  • University of Maryland
  • Massachusetts General Hospital
  • Tufts Medical Center
  • University of Nebraska Medical Center
  • VA Sierra Nevada Health Care System
  • University of New Mexico School of Medicine
  • Syracuse VA Medical Center
  • Cleveland Clinic
  • Legacy Hospital
  • University of Pittsburgh Medical Center
  • Baylor Scott White - Plano
  • Intermountain Medical Center
  • University of Utah Cardiovascular Center
  • University of Wisconsin Hospital and Clinics
  • Sanatorio de la Trinidad Mitre
  • Sanatorio Guemes
  • Nexo Salud Investigacion Clinica
  • Queensland Lung Transplant Service
  • St Vincent's hospital
  • LKH-Univ. Klinikum Graz
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medizinische Universität Wien
  • Military Medical Academy
  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
  • University Of Calgary - Peter Lougheed Centre
  • University of Alberta Hospital
  • University Health Network - Toronto General Hospital
  • Beijing Chaoyang Hospital
  • Beijing Anzhen Hospital
  • China-Japan Friendship Hospital
  • Beijing Shijitan Hospital
  • The First Affiliated Hospital of Chongqing Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  • Zhongda Hospital,Southeast University
  • The Affiliated Hospital of Medical College Qingdao University
  • Huashan Hospital of Fudan University
  • Shanghai Pulmonary Hospital
  • Zhongshan Hospital,Fudan University
  • The General Hospital of Northern Theater Command
  • Tianjin Medical University General Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Fundacion Neumologica Colombiana
  • Fundación Abood Shaio
  • Clínica Imbanaco S.A.S.
  • Centro Cardiovascular Colombiano Clínica Santa María
  • General University Hospital II.department of Internal Medicine-cardiology and angiology
  • Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
  • CHU de Brest - Hôpital de la Cavale Blanche
  • CHU de Grenoble - Hopital Albert Michallon
  • Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud
  • Hôpital Cardiologique - Chru Lille
  • CHU de Montpellier - Arnaud de Villeneuve
  • CHU Saint-Etienne - Hôpital Nord
  • Hopital Larrey CHU de Toulouse
  • CHU de Nancy - Hôpital de Brabois
  • Universitatsklinikum Bonn
  • Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden
  • Universitaetsklinikum Giessen
  • Universitaetsklinikum Hamburg Eppendorf
  • Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie
  • Thoraxklinik Heidelberg
  • Universitaetsklinikum des Saarlandes
  • Universitätsklinikum Jena
  • Krankenhaus Neuwittelsbach
  • Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
  • Tel Aviv Medical Center
  • The Chaim Sheba Medical Center
  • Ospedale SS. Annunziata
  • Fondazione IRCCS Policlinico San Matteo
  • Fondazione Toscana Gabriele Monasterio CNR
  • Policlinico Gemelli Universita Cattolica
  • A.O.U. Città della Salute e della Scienza
  • The University of Tokyo Hospital
  • Kyushu University Hospital
  • Kure Kyosai Hospital
  • St.Marianna University Hospital
  • Kobe University Hospital
  • University Hospital Kyoto Perfectural University of Medicine
  • Kyoto University Hospital
  • Shinshu University Hospital
  • Toho University Medical Center, Ohashi Hospital
  • Kyorin University Hospital
  • Nagoya University Hospital
  • National Hospital Organization Okayama Medical Center
  • Hokkaido University Hospital
  • National Cerebral and Cardiovascular Center
  • Juntendo University Hospital
  • University of Tsukuba Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
  • Vilnius University Hospital Santariskiu Klinikos
  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez
  • Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
  • Centro de Investigacion Clinica Chapultepec
  • CRI Centro Regiomontano de Investigacion SC
  • Krakowski Szpital Specjalistyczny im Jana Pawla II
  • Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, PZOZ
  • Europejskie Centrum Zdrowia Otwock Sp. z o.o
  • Hosp. Garcia de Orta
  • Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III
  • Spitalul Clinic Judetean de Urgenta
  • State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
  • Moscow City Clinical Hospital No.51
  • National Medical Research Center of Cardiology of MoH of Russian Federation
  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
  • Volgograd Regional Clinical Cardiology Center
  • King Faisal Specialist Hospital & Research Center
  • King Fahad Medical City
  • University Clinical Center of Serbia
  • Institute for Pulmonary Disease of Vojvodina
  • National University Heart Centre, Singapore
  • National Heart Centre (NHC) Singapore
  • Narodny ustav srdcovych a cievnych chorob
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. La Paz
  • Hosp. Costa Del Sol
  • Hosp. Virgen de La Victoria
  • Hosp. Gral. Univ. de Toledo
  • Kaohsiung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang-Gung Memorial Hospital, LinKou Branch
  • Maharaj Nakorn Chiang Mai Hospital
  • Srinagarind Hospital, Khon Kaen University
  • Thammasat Hospital
  • Adana City Hospital
  • Cukurova University Medical Faculty
  • Hacettepe University Medical Faculty
  • Ankara Bilkent Sehir Hastanesi
  • Pamukkale University Medical Faculty
  • Eskisehir Osmangazi University Medical Faculty Hospital
  • Istanbul University - Cerrahpasa Cardiology Institution
  • Siyami Ersek Training and Research Hospital
  • Marmara University Medical Faculty
  • Ege University Medical Faculty
  • Dokuz Eylul University Medical Faculty
  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
  • Mersin University Medical Faculty
  • CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
  • CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
  • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
  • Papworth Hospital NHS Trust
  • National Waiting Times Centre Board Golden Jubilee National Hospital
  • Royal Free Hospital
  • Hammersmith Hospital
  • Freeman Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Macitentan

Placebo

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change From Baseline to Week 28 in 6- minute Walk Distance [6MWD]
Change from baseline to week 28 in 6MWD as measured by 6-minute walk test [6MWT]) will be reported. The purpose of the six-minute walk test (6MWT) is to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes.

Secondary Outcome Measures

Time to Clinical Worsening up to End-of double-blind-treatment (EODBT) Period
Time to first Clinical Event Committee (CEC) confirmed clinical worsening up to EODBT will be reported. Clinical worsening is 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 cannot 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 worsening signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH.
Number of Participants with Improvement in WHO Functional Class (WHO FC) From Baseline to Week 28
Improvement in WHO FC from baseline to Week 28 will be calculated for each participant. WHO FC test is used to assess disease severity. Four functional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms Based on (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score
The Cardiopulmonary Symptoms domain consists of 6 items (shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough) reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT will be administered daily over a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. Questionnaires to be completed at site at screening for training purpose. PAH-SYMPACT to be performed at home, during the 7-day period prior to the scheduled visit.
Change from Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score
The Cardiovascular Symptoms domain consists of 5 items (heart palpitations [fluttering], rapid heartbeat, chest pain, chest tightness, and lightheadedness) reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT will be administered daily over a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. Questionnaires to be completed at site at screening for training purpose. PAH-SYMPACT to be performed at home, during the 7-day period prior to the scheduled visit.
Change from baseline to Week 28 in Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) Utility Score
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
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 will be assessed.

Full Information

First Posted
February 13, 2020
Last Updated
October 11, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT04271475
Brief Title
A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Acronym
MACiTEPH
Official Title
A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
May 14, 2024 (Anticipated)
Study Completion Date
August 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Thromboembolic Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Macitentan
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Macitentan
Other Intervention Name(s)
ACT-064992,, Opsumit
Intervention Description
Participants will receive Macitentan film-coated tablets orally od.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participant will receive matching placebo tablets orally od.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 28 in 6- minute Walk Distance [6MWD]
Description
Change from baseline to week 28 in 6MWD as measured by 6-minute walk test [6MWT]) will be reported. The purpose of the six-minute walk test (6MWT) is to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes.
Time Frame
Baseline up to Week 28
Secondary Outcome Measure Information:
Title
Time to Clinical Worsening up to End-of double-blind-treatment (EODBT) Period
Description
Time to first Clinical Event Committee (CEC) confirmed clinical worsening up to EODBT will be reported. Clinical worsening is 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 cannot 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 worsening signs or symptoms of right heart failure; 5) Rescue pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA) procedure due to worsening of PH.
Time Frame
Up to EODBT (variable duration per participant, up to 3.5 years)
Title
Number of Participants with Improvement in WHO Functional Class (WHO FC) From Baseline to Week 28
Description
Improvement in WHO FC from baseline to Week 28 will be calculated for each participant. WHO FC test is used to assess disease severity. Four functional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Time Frame
Baseline up to Week 28
Title
Change From Baseline to Week 28 in Pulmonary Arterial Hypertension - Symptoms Based on (PAH-SYMPACT) - Cardiopulmonary Symptom Domain Score
Description
The Cardiopulmonary Symptoms domain consists of 6 items (shortness of breath, fatigue, lack of energy, swelling in ankles or legs, swelling in stomach area and cough) reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT will be administered daily over a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. Questionnaires to be completed at site at screening for training purpose. PAH-SYMPACT to be performed at home, during the 7-day period prior to the scheduled visit.
Time Frame
Baseline up to Week 28
Title
Change from Baseline to Week 28 in PAH-SYMPACT - Cardiovascular Symptom Domain Score
Description
The Cardiovascular Symptoms domain consists of 5 items (heart palpitations [fluttering], rapid heartbeat, chest pain, chest tightness, and lightheadedness) reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT will be administered daily over a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. Questionnaires to be completed at site at screening for training purpose. PAH-SYMPACT to be performed at home, during the 7-day period prior to the scheduled visit.
Time Frame
Baseline up to Week 28
Title
Change from baseline to Week 28 in Euro Quality of life-5-Dimension-5-Level (EQ-5D-5L) Utility Score
Description
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline up to Week 28
Title
Change From Baseline to Week 28 in Accelerometer-assessed Proportion of Time Spent in Moderate to Vigorous Physical Activity
Description
Change from baseline to week 28 in accelerometer-assessed proportion of time spent in moderate to vigorous physical activity will be assessed.
Time Frame
Baseline up to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Actelion Clinical Trial
Organizational Affiliation
Actelion
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-2201
Country
United States
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Florida Health Jacksonville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
21118
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2265
Country
United States
Facility Name
VA Sierra Nevada Health Care System
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
University of New Mexico School of Medicine
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Syracuse VA Medical Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Legacy Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor Scott White - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Cardiovascular Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-2442
Country
United States
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Sanatorio Guemes
City
C.a.b.a.
ZIP/Postal Code
C1180AAX
Country
Argentina
Facility Name
Nexo Salud Investigacion Clinica
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1006ACC
Country
Argentina
Facility Name
Queensland Lung Transplant Service
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
St Vincent's hospital
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
LKH-Univ. Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
University Of Calgary - Peter Lougheed Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Beijing Chaoyang Hospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100038
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510140
Country
China
Facility Name
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Zhongda Hospital,Southeast University
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
The Affiliated Hospital of Medical College Qingdao University
City
Qingdao
ZIP/Postal Code
266003
Country
China
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Zhongshan Hospital,Fudan University
City
Shanghai
Country
China
Facility Name
The General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tian Jin
ZIP/Postal Code
300052
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'An
ZIP/Postal Code
710061
Country
China
Facility Name
Fundacion Neumologica Colombiana
City
Bogota
ZIP/Postal Code
1101131
Country
Colombia
Facility Name
Fundación Abood Shaio
City
Bogota
ZIP/Postal Code
85369
Country
Colombia
Facility Name
Clínica Imbanaco S.A.S.
City
Cali
ZIP/Postal Code
760042
Country
Colombia
Facility Name
Centro Cardiovascular Colombiano Clínica Santa María
City
Medellin
ZIP/Postal Code
681004
Country
Colombia
Facility Name
General University Hospital II.department of Internal Medicine-cardiology and angiology
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
CHU de Brest - Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHU de Grenoble - Hopital Albert Michallon
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud
City
Le Kremlin-Bicetre Cedex
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Cardiologique - Chru Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Montpellier - Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Saint-Etienne - Hôpital Nord
City
St Priest en Jarez Cedex
ZIP/Postal Code
42277
Country
France
Facility Name
Hopital Larrey CHU de Toulouse
City
Toulouse Cedex 9
Country
France
Facility Name
CHU de Nancy - Hôpital de Brabois
City
Vandoeuvre les Nancy Cedex
ZIP/Postal Code
54511
Country
France
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitaetsklinikum Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Krankenhaus Neuwittelsbach
City
München
ZIP/Postal Code
80639
Country
Germany
Facility Name
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Ospedale SS. Annunziata
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio CNR
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Policlinico Gemelli Universita Cattolica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
The University of Tokyo Hospital
City
Bunkyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kure Kyosai Hospital
City
Hiroshima
ZIP/Postal Code
737-8505
Country
Japan
Facility Name
St.Marianna University Hospital
City
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kobe University Hospital
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
University Hospital Kyoto Perfectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Toho University Medical Center, Ohashi Hospital
City
Meguro-ku
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-Shi
ZIP/Postal Code
564-8565
Country
Japan
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
University of Tsukuba Hospital
City
Tsukuba-City
ZIP/Postal Code
305-8576
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
City
Kaunas
ZIP/Postal Code
50161
Country
Lithuania
Facility Name
Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
City
Ciudad De México
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
City
Mexico
ZIP/Postal Code
52787
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Centro de Investigacion Clinica Chapultepec
City
Morelia
ZIP/Postal Code
58260
Country
Mexico
Facility Name
CRI Centro Regiomontano de Investigacion SC
City
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Krakowski Szpital Specjalistyczny im Jana Pawla II
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, PZOZ
City
Lublin
ZIP/Postal Code
20-708
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Sp. z o.o
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Hosp. Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta
City
Tg. Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital No.51
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
National Medical Research Center of Cardiology of MoH of Russian Federation
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Volgograd Regional Clinical Cardiology Center
City
Volgograd
ZIP/Postal Code
400008
Country
Russian Federation
Facility Name
King Faisal Specialist Hospital & Research Center
City
Riyadh
ZIP/Postal Code
12713
Country
Saudi Arabia
Facility Name
King Fahad Medical City
City
Riyadh
ZIP/Postal Code
59046
Country
Saudi Arabia
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for Pulmonary Disease of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
National University Heart Centre, Singapore
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
National Heart Centre (NHC) Singapore
City
Singapore
ZIP/Postal Code
169609
Country
Singapore
Facility Name
Narodny ustav srdcovych a cievnych chorob
City
Bratislava
ZIP/Postal Code
833 48
Country
Slovakia
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Costa Del Sol
City
Malaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hosp. Gral. Univ. de Toledo
City
Toledo
ZIP/Postal Code
45007
Country
Spain
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital, LinKou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Thammasat Hospital
City
Pathumthani
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Adana City Hospital
City
Adana
ZIP/Postal Code
01170
Country
Turkey
Facility Name
Cukurova University Medical Faculty
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara Bilkent Sehir Hastanesi
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Facility Name
Pamukkale University Medical Faculty
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Facility Name
Eskisehir Osmangazi University Medical Faculty Hospital
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Facility Name
Istanbul University - Cerrahpasa Cardiology Institution
City
Istanbul
ZIP/Postal Code
34096
Country
Turkey
Facility Name
Siyami Ersek Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Facility Name
Marmara University Medical Faculty
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Facility Name
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Dokuz Eylul University Medical Faculty
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
City
Kartal-Istanbul
ZIP/Postal Code
34865
Country
Turkey
Facility Name
Mersin University Medical Faculty
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Facility Name
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
City
Dnipro
ZIP/Postal Code
49059
Country
Ukraine
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
02000
Country
Ukraine
Facility Name
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Papworth Hospital NHS Trust
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Facility Name
National Waiting Times Centre Board Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2RX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

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