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A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment (SELECT)

Primary Purpose

Chronic Thromboembolic Pulmonary Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Selexipag
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 focused on measuring CTEPH, selexipag

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  • Signed and dated informed consent form
  • Male and female participants from greater than or equal to (>) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and less then or equal to (<=85) years old at Screening (Visit 1)
  • With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee
  • With pulmonary hypertension (PH) in WHO FC I-IV.
  • Participant able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
  • Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.

Main Exclusion Criteria:

  • Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
  • Known concomitant life-threatening disease with a life expectancy < 12 months.
  • Planned balloon pulmonary angioplasty within 26 weeks after randomization.
  • Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort
  • Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC
  • Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed)
  • Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).
  • Any other criteria as per selexipag Summary of Product Characteristics (SmPC).
  • Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease

Sites / Locations

  • University of California San Diego Medical Center
  • University of Southern California, Keck School of Medicine
  • University of Colorado - Anschutz Medical Campus
  • Colorado Springs Pulmonary Consultants
  • South Denver Cardiology Associates PC
  • Mayo Clinic in Florida
  • Piedmont Healthcare
  • Emory University
  • Northwestern University Feinberg School of Medicine
  • University of Chicago Hospitals - Chicago
  • Advocate Christ Medical Center
  • University of Maryland
  • University of Michigan
  • Sparrow Clinical Research Institute
  • Mayo Clinic
  • Washington University in St. Louis
  • University of Nebraska Medical Center
  • St. Mary's Cardiology
  • University of New Mexico Clinical & Translational Science Center
  • Duke University Medical Center
  • University of Cincinnati Medical Center
  • Cleveland Clinic
  • Temple University Hospital
  • Allegheny
  • University of Pittsburgh Medical Center
  • University of Texas Southwestern Medical Center
  • Houston Methodist Hospital
  • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
  • Intermountain Medical Center
  • University of Utah Cardiovascular Center
  • Medical College of Wisconsin-Froedtert Hospital
  • Aurora Saint Lukes Medical Center
  • Sanatorio de la Trinidad Mitre
  • Hospital Italiano de Buenos Aires
  • Sanatorio Ramon Cereijo
  • Instituto de Cardiología y Cirugía Cardiovascular - Fundación Favaloro
  • Hospital General de Agudos Dr Cosme Argerich
  • Hospital Britanico de Buenos Aires
  • Centro Médico Dra. De Salvo
  • Royal Adelaide Hospital
  • Queensland Lung Transplant Service
  • St Vincent's hospital
  • Pulmonary Arterial Hypertension Clinic
  • The Alfred Hospital
  • Westmead Hospital
  • Ordensklinikum Linz GmbH Elisabethinen
  • Medical University Vienna
  • ULB Hôpital Erasme
  • UZ Leuven
  • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
  • Universidade Federal de Goias - Hospital das Clinicas da UFG
  • Irmandade Santa Casa de Misericordia de Porto Alegre
  • Hospital das Clinicas de Porto Alegre
  • União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
  • Fundacao do ABC - Centro Universitario FMABC
  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • UMHAT 'Heart and Brain Center for Excellence'
  • National Cardiology Hospital
  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
  • University Of Calgary - Peter Lougheed Centre
  • Vancouver General Hospital
  • London Health Sciences Centre - Victoria Hospital
  • Jewish General Hospital
  • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
  • Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
  • The First Affiliated Hospital of Guangzhou Medical University
  • The General Hospital of Northern Theater Command
  • Shengjing Hospital of China Medical University
  • Shanxi Cardiovascular Hospital
  • Tianjin Medical University General Hospital
  • General University Hospital II.department of Internal Medicine-cardiology and angiology
  • Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
  • Rigshospitalet Kardiologisk Klinisk
  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
  • Universitätsklinikum Giessen Medizinische Klinik Und Poliklinik Ii, Pneumologie
  • Universität Greifswald - Klinik Für Innere Medizin Bereich Pneumologie/Infektiologie
  • Universitätsklinikum Hamburg-Eppendorf - Pneumologie
  • Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie
  • Thoraxklinik am Universitätsklinikum Heidelberg
  • Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
  • Universitätsklinikum Leipzig / Medizinischen Klinik und Poliklinik I, Abteilung für Pneumologie
  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik
  • Semmelweis Egyetem,Pulmonológiai Klinika
  • Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
  • Pecsi Tudomanyegyetem Klinikai Kozpont
  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
  • Rabin Medical Center, Beilinson Campus
  • The Chaim Sheba Medical Center
  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi
  • Fondazione IRCCS Policlinico San Matteo
  • Policlinico Umberto I
  • Ospedale di Cattinara - Struttura complessa di Pneumologia
  • Pusan National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • Hospital Pulau Pinang
  • Hospital Serdang
  • Institut Jantung Negara (National Heart Institute)
  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez
  • CICUM San Miguel
  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
  • VUMC Amsterdam
  • St. Antonius Ziekenhuis Nieuwegein
  • Uniwersyteckie Centrum Kliniczne
  • Krakowski Szpital Specjalistyczny im Jana Pawla II
  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
  • NZOZ Europejskie Centrum Zdrowia Otwock
  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
  • Warszawski Uniwersytet Medyczny, Szpital Kliniczny Dzieciątka Jezus
  • Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy
  • Hospital Garcia de Orta
  • Hospitais da universidade de Coimbra
  • Centro Hospitalar de Lisboa Norte
  • Hospital Geral de Santo Antonio
  • Irkutsk Regional Clinical Hospital
  • Cardiovascular Pathology Research Institute of Siberian Branch of RAMS
  • Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
  • Moscow City Clinical Hospital No.51
  • National Medical Research Center of Cardiology of MoH of Russian Federation
  • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
  • Narodny ustav srdcovych a cievnych chorob
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Virgen Del Rocio
  • Hosp. Univ. I Politecni La Fe
  • Norrlands Universitetssjukhus
  • Uppsala Akademiska Sjukhuset, Kardiologkliniken
  • Universitatsspital Zurich
  • Kaohsiung Veterans General Hospital
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Ramathibodi Hospital, Mahidol University
  • Srinagarind Hospital, Khon Kaen University
  • Hacettepe University Medical Faculty
  • Ankara University Medical Faculty
  • Istanbul University Istanbul Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Marmara University Medical Faculty
  • Ege University Medical Faculty
  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
  • CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
  • Lviv Regional Clinical Hospital
  • Papworth Hospital NHS Trust
  • National Waiting Times Centre Board Golden Jubilee National Hospital
  • Royal Free Hospital
  • Royal Brompton Hospital
  • Hammersmith Hospital
  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Selexipag DB

Placebo DB

Selexipag OL

Arm Description

During the double blind treatment period, participants in this group will receive selexipag. Each participant will start with one oral tablet of selexipag 200 µg in the evening of Day 1 and will continue with 200 µg twice daily (b.i.d.) on Day 2. If this dose is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg until reaching the individual maximal tolerated dose (iMTD) in the range of 200 to 1600 µg b.i.d. The up-titration period up to Week 12 is followed by a stable maintenance treatment period from Week 12 to Week 26, at the iMTD. After Week 26, further up-titration can be allowed (but not above 1600 µg b.i.d.).

During the double-blind treatment period, participants in this group will receive the oral matching placebo, twice daily. A (mock) up-titration scheme will be followed.

All participants who completed the double-blind treatment period, whether they received placebo or selexipag during the double-blind period, will receive selexipag during the open-label extension period, using the same up-titration schedule as in the double-blind period.

Outcomes

Primary Outcome Measures

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
Change from baseline in PVR at Week 20 was reported. PVR was measured by accessing the vessel either from right heart catheterization or left heart catheterization, if required. Change from baseline in PVR was measured as percent ratio of post treatment value (Week 20) to pre-treatment value (baseline).

Secondary Outcome Measures

Full Information

First Posted
September 27, 2018
Last Updated
July 20, 2023
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT03689244
Brief Title
A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
Acronym
SELECT
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study did not demonstrate efficacy on the primary endpoint, PVR vs. placebo at wk 20 at a planned interim analysis.
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)

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
Yes

5. Study Description

Brief Summary
Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH.
Detailed Description
Participants will be recruited in two sequential cohorts: approximately the first 90 randomized participants will undergo a right heart catheterization (RHC) (and left heart catheterization LHC, if needed) with measurement of pulmonary vascular resistance (PVR) at Week 20 and will constitute the hemodynamic cohort; the remaining participants will constitute the non-hemodynamic cohort; who do not require a post-baseline hemodynamic assessment. They will undergo the same overall study assessments as the hemodynamic cohort excepted for RHC at Week 20.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selexipag DB
Arm Type
Experimental
Arm Description
During the double blind treatment period, participants in this group will receive selexipag. Each participant will start with one oral tablet of selexipag 200 µg in the evening of Day 1 and will continue with 200 µg twice daily (b.i.d.) on Day 2. If this dose is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg until reaching the individual maximal tolerated dose (iMTD) in the range of 200 to 1600 µg b.i.d. The up-titration period up to Week 12 is followed by a stable maintenance treatment period from Week 12 to Week 26, at the iMTD. After Week 26, further up-titration can be allowed (but not above 1600 µg b.i.d.).
Arm Title
Placebo DB
Arm Type
Placebo Comparator
Arm Description
During the double-blind treatment period, participants in this group will receive the oral matching placebo, twice daily. A (mock) up-titration scheme will be followed.
Arm Title
Selexipag OL
Arm Type
Experimental
Arm Description
All participants who completed the double-blind treatment period, whether they received placebo or selexipag during the double-blind period, will receive selexipag during the open-label extension period, using the same up-titration schedule as in the double-blind period.
Intervention Type
Drug
Intervention Name(s)
Selexipag
Other Intervention Name(s)
ACT-293987, JNJ-67896049
Intervention Description
oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 to 8 tablets at each administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets without active compound
Primary Outcome Measure Information:
Title
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
Description
Change from baseline in PVR at Week 20 was reported. PVR was measured by accessing the vessel either from right heart catheterization or left heart catheterization, if required. Change from baseline in PVR was measured as percent ratio of post treatment value (Week 20) to pre-treatment value (baseline).
Time Frame
Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Signed and dated informed consent form Male and female participants from greater than or equal to (>) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) and less then or equal to (<=85) years old at Screening (Visit 1) With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee With pulmonary hypertension (PH) in WHO FC I-IV. Participant able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit. Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization. Main Exclusion Criteria: Planned or current treatment with another investigational treatment up to 3 months prior to randomization. Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease. Known concomitant life-threatening disease with a life expectancy < 12 months. Planned balloon pulmonary angioplasty within 26 weeks after randomization. Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag) within 90 days prior to randomization (visit 2) except those given at vasodilator testing during RHC Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed) Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc). Any other criteria as per selexipag Summary of Product Characteristics (SmPC). Exclusion criteria related to comorbidities: severe coronary heart disease or unstable angina as assessed by the investigator; mocardial infarction within the last 6 months prior to or during Screening; decompensated cardiac failure if not under close supervision; severe arrhythmias as assessed by the investigator; cerebrovascular events (example transient ischemic attack, stroke) within the last 3 months prior to or during screening; congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension. (PH); known or suspicion of pulmonary veno-occlusive disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Borissoff, MD, PhD
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
University of Southern California, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
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
Colorado Springs Pulmonary Consultants
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Piedmont Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
University of Chicago Hospitals - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
St. Mary's Cardiology
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
University of New Mexico Clinical & Translational Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140-5103
Country
United States
Facility Name
Allegheny
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Baylor Scott & White Research Institute at The Heart Hospital Baylor 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
84175
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
Medical College of Wisconsin-Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Aurora Saint Lukes Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Sanatorio de la Trinidad Mitre
City
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Caba
ZIP/Postal Code
1199ABB
Country
Argentina
Facility Name
Sanatorio Ramon Cereijo
City
Caba
ZIP/Postal Code
C1048AAN
Country
Argentina
Facility Name
Instituto de Cardiología y Cirugía Cardiovascular - Fundación Favaloro
City
Caba
ZIP/Postal Code
C1093AAS
Country
Argentina
Facility Name
Hospital General de Agudos Dr Cosme Argerich
City
Caba
ZIP/Postal Code
C1155AHD
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires
City
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Centro Médico Dra. De Salvo
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
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
Pulmonary Arterial Hypertension Clinic
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
ULB Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Universidade Federal De Minas Gerais - Hospital das Clínicas
City
Belo Horizonte
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
City
Belo Horizonte
ZIP/Postal Code
30441-070
Country
Brazil
Facility Name
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
City
Fortaleza
ZIP/Postal Code
60840-285
Country
Brazil
Facility Name
Universidade Federal de Goias - Hospital das Clinicas da UFG
City
Goiânia
ZIP/Postal Code
74605-020
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericordia de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Fundacao do ABC - Centro Universitario FMABC
City
Santo Andre
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04037-003
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
UMHAT 'Heart and Brain Center for Excellence'
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
National Cardiology Hospital
City
Sofia
ZIP/Postal Code
1392
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
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Institut Universitaire De Cardiologie Et De Pneumologie De Québec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
The General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110000
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Shanxi Cardiovascular Hospital
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tian Jin
ZIP/Postal Code
300052
Country
China
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
Arhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet Kardiologisk Klinisk
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Giessen Medizinische Klinik Und Poliklinik Ii, Pneumologie
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universität Greifswald - Klinik Für Innere Medizin Bereich Pneumologie/Infektiologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf - Pneumologie
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 am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinikum Leipzig / Medizinischen Klinik und Poliklinik I, Abteilung für Pneumologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
City
Würzburg
ZIP/Postal Code
97074
Country
Germany
Facility Name
Semmelweis Egyetem,Pulmonológiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale di Cattinara - Struttura complessa di Pneumologia
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Serdang
City
Kajang
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Institut Jantung Negara (National Heart Institute)
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
City
Ciudad de Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
CICUM San Miguel
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
City
Monterrey
ZIP/Postal Code
64718
Country
Mexico
Facility Name
VUMC Amsterdam
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Krakowski Szpital Specjalistyczny im Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
NZOZ Europejskie Centrum Zdrowia Otwock
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Warszawski Uniwersytet Medyczny, Szpital Kliniczny Dzieciątka Jezus
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospitais da universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte
City
Lisbon
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Irkutsk Regional Clinical Hospital
City
Irkutsk
ZIP/Postal Code
664049
Country
Russian Federation
Facility Name
Cardiovascular Pathology Research Institute of Siberian Branch of RAMS
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital #1 n.a. N.I.Pirogov
City
Moscow
ZIP/Postal Code
119049
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
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
City
Novosibirsk
ZIP/Postal Code
630055
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
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. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39011
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Univ. I Politecni La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Norrlands Universitetssjukhus
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Uppsala Akademiska Sjukhuset, Kardiologkliniken
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Universitatsspital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Ramathibodi Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34096
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
Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
City
Kartal-Istanbul
ZIP/Postal Code
34865
Country
Turkey
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
SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'
City
Kyiv
ZIP/Postal Code
03038
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital
City
Lviv
ZIP/Postal Code
79000
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
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
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
Actelion is a Janssen pharmaceutical company of Johnson & Johnson. 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 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 Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment

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