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AzTrials

Chronic Thromboembolic Pulmonary HypertensionPhase 3SELECTNCT03689244

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

A Phase 3 study testing Selexipag in people with Chronic Thromboembolic Pulmonary Hypertension, run by Actelion at 162 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Selexipag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
162 sitesin 31 countries
Study dates
23 Jan 2019to 7 Jun 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

162 sites in 31 countries.

162 sites in 31 countries

United States32 sites

  • University of New Mexico Clinical & Translational Science Center

    Albuquerque, New Mexico, 87131

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Chicago Hospitals - Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Colorado Springs Pulmonary Consultants

    Colorado Springs, Colorado, 80907

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32259

  • University of California San Diego Medical Center

    La Jolla, California, 92037

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • University of Southern California, Keck School of Medicine

    Los Angeles, California, 90033

  • Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53211

  • Aurora Saint Lukes Medical Center

    Milwaukee, Wisconsin, 53215

  • Intermountain Medical Center

    Murray, Utah, 84175

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140-5103

  • Allegheny

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • St. Mary's Cardiology

    Reno, Nevada, 89503

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah Cardiovascular Center

    Salt Lake City, Utah, 84132

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

Brazil11 sites

  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 30130-100

  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

    Belo Horizonte, 30441-070

  • Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

    Botucatu, 18618-686

  • Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

    Fortaleza, 60840-285

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-003

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Fundacao do ABC - Centro Universitario FMABC

    Santo André, 09060-870

  • SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

    São Paulo, 04037-003

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000

Other trials in Brazil

Germany9 sites

  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

    Dresden, 01307

  • Universitätsklinikum Giessen Medizinische Klinik Und Poliklinik Ii, Pneumologie

    Giessen, 35392

  • Universität Greifswald - Klinik Für Innere Medizin Bereich Pneumologie/Infektiologie

    Greifswald, 17475

  • Universitätsklinikum Hamburg-Eppendorf - Pneumologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie

    Hanover, 30625

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

    Homburg/Saar, 66421

  • Universitätsklinikum Leipzig Medizinischen Klinik und Poliklinik I, Abteilung für Pneumologie

    Leipzig, 04103

  • Klinikum Würzburg Mitte gGmbH Standort Missioklinik

    Würzburg, 97074

Other trials in Germany

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Krakowski Szpital Specjalistyczny im Jana Pawla II

    Krakow, 31-202

  • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

    Lublin, 20-718

  • NZOZ Europejskie Centrum Zdrowia Otwock

    Otwock, 05-400

  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

    Poznan, 61-848

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

    Szczecin, 70-111

  • Warszawski Uniwersytet Medyczny, Szpital Kliniczny Dzieciątka Jezus

    Warsaw, 02-005

  • Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

    Wroclaw, 51-124

Other trials in Poland

Argentina7 sites

  • Sanatorio de la Trinidad Mitre

    Buenos Aires, C1039AAO

  • Centro Médico Dra. De Salvo

    Buenos Aires, C1426ABP

  • Hospital Italiano de Buenos Aires

    Caba, 1199ABB

  • Sanatorio Ramon Cereijo

    Caba, C1048AAN

  • Instituto de Cardiología y Cirugía Cardiovascular - Fundación Favaloro

    Caba, C1093AAS

  • Hospital General de Agudos Dr Cosme Argerich

    CABA, C1155AHD

  • Hospital Britanico de Buenos Aires

    CABA, C1280AEB

Other trials in Argentina

Russia7 sites

  • Irkutsk Regional Clinical Hospital

    Irkutsk, 664049

  • Cardiovascular Pathology Research Institute of Siberian Branch of RAMS

    Kemerovo, 650002

  • Moscow City Clinical Hospital #1 n.a. N.I.Pirogov

    Moscow, 119049

  • Moscow City Clinical Hospital No.51

    Moscow, 121309

  • National Medical Research Center of Cardiology of MoH of Russian Federation

    Moscow, 121552

  • E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation

    Novosibirsk, 630055

  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

    Saint Petersburg, 197341

Other trials in Russia

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty

    Ankara, 6100

  • Ankara University Medical Faculty

    Ankara, 6500

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34096

  • Marmara University Medical Faculty

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

    Kartal Istanbul, 34865

Other trials in Turkey (Türkiye)

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Queensland Lung Transplant Service

    Chermside, 4032

  • St Vincent's hospital

    Darlinghurst, 2010

  • Pulmonary Arterial Hypertension Clinic

    Hobart, 7000

  • The Alfred Hospital

    Melbourne, 3004

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

China6 sites

  • Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)

    Beijing, 100730

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • The General Hospital of Northern Theater Command

    Shenyang, 110000

  • Shengjing Hospital Of China Medical University

    Shenyang, 110022

  • Shanxi Cardiovascular Hospital

    Taiyuan, 030001

  • Tianjin Medical University General Hospital

    Tianjin, 300052

Other trials in China

Spain6 sites

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Vall D Hebron

    Barcelona, 8035

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39011

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom6 sites

  • Papworth Hospital NHS Trust

    Cambridge, CB2 0AY

  • National Waiting Times Centre Board Golden Jubilee National Hospital

    Glasgow, G81 4DY

  • Royal Free Hospital

    London, NW3 2QG

  • Royal Brompton Hospital

    London, SW3 6NP

  • Hammersmith Hospital

    London, W12 0HS

  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

    Sheffield, S10 2RX

Other trials in United Kingdom

Canada5 sites

  • University Of Calgary - Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A 5W9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Institut Universitaire De Cardiologie Et De Pneumologie De Québec

    Québec, Quebec, G1V 4G5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Hungary5 sites

  • Semmelweis Egyetem,Pulmonológiai Klinika

    Budapest, 1083

  • Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

    Budapest, 1096

  • Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs, 7624

  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

    Szeged, 6720

Other trials in Hungary

South Korea5 sites

  • Pusan National University Hospital

    Busan, 49241

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul National University Hospital

    Seoul, 3080

Other trials in South Korea

Italy4 sites

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Policlinico Umberto I

    Roma, 00161

  • Ospedale di Cattinara - Struttura complessa di Pneumologia

    Trieste, 34149

Other trials in Italy

Portugal4 sites

  • Hospital Garcia de Orta

    Almada, 2801-951

  • Hospitais da universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar de Lisboa Norte

    Lisbon, 1649-028

  • Hospital Geral de Santo Antonio

    Porto, 4099-001

Other trials in Portugal

Taiwan4 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

Ukraine4 sites

  • CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

    Dnipro, 49059

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 02000

  • SI 'National Institute of Phtisiology and Pulmonology n.a. F.G. Yanovsky of NAMS of Ukraine'

    Kyiv, 03038

  • Lviv Regional Clinical Hospital

    Lviv, 79000

Other trials in Ukraine

Bulgaria3 sites

  • UMHAT 'Heart and Brain Center for Excellence'

    Pleven, 5800

  • National Cardiology Hospital

    Sofia, 1392

  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

    Sofia, 1750

Other trials in Bulgaria

Malaysia3 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Serdang

    Kajang, 43000

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400

Other trials in Malaysia

Mexico3 sites

  • CICUM San Miguel

    Guadalajara, 44160

  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez

    Mexico City, 14000

  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

    Monterrey, 64718

Other trials in Mexico

Austria2 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Belgium2 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Denmark2 sites

  • Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

    Aarhus, 8200

  • Rigshospitalet Kardiologisk Klinisk

    Copenhagen, 2100

Other trials in Denmark

Israel2 sites

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Netherlands2 sites

  • VUMC Amsterdam

    Amsterdam, 1081 HV

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

Other trials in Netherlands

Sweden2 sites

  • Norrlands Universitetssjukhus

    Umeå, 901 85

  • Uppsala Akademiska Sjukhuset, Kardiologkliniken

    Uppsala, 751 85

Other trials in Sweden

Thailand2 sites

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

Czechia1 site

  • General University Hospital II.department of Internal Medicine-cardiology and angiology

    Prague, 128 08

Other trials in Czechia

Slovakia1 site

  • Narodny ustav srdcovych a cievnych chorob

    Bratislava, 833 48

Other trials in Slovakia

Switzerland1 site

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
Selexipag, Placebo
Keywords
CTEPH, selexipag

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelexipagDrug

    Also called ACT-293987, JNJ-67896049

    oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 to 8 tablets at each administration

  • PlaceboDrug

    Oral tablets without active compound

Study groups in NCT03689244
Study groupRoleWhat they receive
Selexipag DBExperimentalDuring 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.).
Receives: Drug: Selexipag
Placebo DBPlacebo comparatorDuring 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.
Receives: Drug: Placebo
Selexipag OLExperimentalAll 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.
Receives: Drug: Selexipag

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start23 Jan 2019
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Why it stopped: The study did not demonstrate efficacy on the primary endpoint, PVR vs. placebo at wk 20 at a planned interim analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689244
Sponsor's protocol ID
AC-065B302
Other IDs
2018-002823-41, 2018
Acronym
SELECT
Status last verified
Jun 2024
First submitted
27 Sep 2018
Last updated
21 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Kim NH, Channick R, Delcroix M, Madani M, Pepke-Zaba J, Borissoff JI, Easton V, Gesang S, Richard D, Ghofrani HA. Efficacy and safety of selexipag in patients with inoperable or persistent/recurrent CTEPH (SELECT randomised trial). Eur Respir J. 2024 Oct 3;64(4):2400193. doi: 10.1183/13993003.00193-2024. Print 2024 Oct.

    PubMed 39326918

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Selexipag in people with Chronic Thromboembolic Pulmonary Hypertension, run by Actelion at 162 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in United States, Brazil, Germany, Poland, Argentina and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20 (time frame: Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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