TerminatedNCT03689244SELECTUpdated Jun 21, 2024Results posted

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 interventional study of Selexipag and Placebo in Chronic Thromboembolic Pulmonary Hypertension, sponsored by Actelion. Terminated at 162 sites in 31 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Actelion · Phase 3, Interventional, and Treatment

Why this study was terminated

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

Phase: Phase 3
Study type: Interventional
Enrollment: 128
Allocation: Randomized
Ages: 18 Years to 85 Years
Sex: All

Study 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.

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.

Conditions studied

Chronic Thromboembolic Pulmonary Hypertension

Browse trials for

Keywords

CTEPH
selexipag

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 128 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Actelion is the lead sponsor of 140 studies on the registry; 1 is open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 24 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 128 participants (actual)

Study arms

Experimental
Selexipag DB
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.).
Drug: Selexipag
Placebo comparator
Placebo DB
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.
Drug: Placebo
Experimental
Selexipag OL
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.
Drug: Selexipag

Interventions

DrugSelexipag
oral tablets containing 200 µg of selexipag. Depending on the iMTD, participants will receive 1 to 8 tablets at each administration
Also known as: ACT-293987, JNJ-67896049
DrugPlacebo
Oral tablets without active compound

What researchers measure

Primary outcomes

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

Results

Posted Aug 9, 2023

Limitations and caveats

Failure to meet success on the primary outcome measure led to termination of the study for futility and thus the pre-planned testing hierarchy was no longer applicable, and all efficacy analyses other than the primary endpoint (PVR) were exploratory.

Participant flow

Double Blind Period (Up to 27.7 Months)

Participant flow — Double Blind Period (Up to 27.7 Months)
Milestone	Double-blind Period: Placebo	Double-blind Period: Selexipag
Started	64	64
Completed	9	6
Not completed	55	58
Withdrew: Withdrawal by subject	7	8
Withdrew: Other	1	1
Withdrew: Sponsor decision	44	47
Withdrew: Death	1	0
Withdrew: Physician decision	2	2

Open Label Period (Up to 20.8 Months)

Participant flow — Open Label Period (Up to 20.8 Months)
Milestone	Open Label Period: Selexipag (Ex-Placebo)	Open Label Period: Selexipag (Ex-Selexipag)
Started	9	6
Completed	0	0
Not completed	9	6
Withdrew: Withdrawal by subject	1	0
Withdrew: Physician decision	1	0
Withdrew: Sponsor decision	7	6

Outcome measures

PrimaryChange 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).

Time frame:: Baseline (Day 1, pre-dose), within 2 to 5 hours post-dose on Week 20
Reported as:: Geometric least squares mean · Percent ratio

Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20
Percent ratio	Double-blind Period: Placebo	Double-blind Period: Selexipag
Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 20	89.52 (81.78 to 97.99)	85.15 (77.97 to 92.99)

Statistical analysis

Double-blind Period: Placebo vs Double-blind Period: Selexipag · ANCOVA · p = 0.412 · Ratio of geometric ls mean: 0.95 · 95% CI 0.84 to 1.07

Adverse events

Collected over For DB period: from first DB dose up to EDBT (that is, up to 27.7 months) and for OL extension period: from first OL dose up to 30 days after the last OL dose (that is, up to 21.8 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Double-blind Period: Placebo	2/64 (3.1%)	16/64 (25%)	45/64 (70.3%)
Double-blind Period: Selexipag	3/64 (4.7%)	9/64 (14.1%)	60/64 (93.8%)
Open Label Period: Selexipag (Ex-Placebo)	0/9 (0%)	0/9 (0%)	9/9 (100%)
Open Label Period: Selexipag (Ex-Selexipag)	0/6 (0%)	1/6 (16.7%)	5/6 (83.3%)

Most frequent serious events

Showing 10 of 34

Most frequent serious events
Event	Double-blind Period: Placebo	Double-blind Period: Selexipag	Open Label Period: Selexipag (Ex-Placebo)	Open Label Period: Selexipag (Ex-Selexipag)
Viral InfectionInfections and infestations	0/64	0/64	0/9	1/6
Right Ventricular FailureCardiac disorders	3/64	5/64	0/9	0/6
Acute Kidney InjuryRenal and urinary disorders	2/64	1/64	0/9	0/6
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders	2/64	0/64	0/9	0/6
Iron Deficiency AnaemiaBlood and lymphatic system disorders	0/64	1/64	0/9	0/6
Atrial FlutterCardiac disorders	1/64	0/64	0/9	0/6
Atrioventricular Block Second DegreeCardiac disorders	1/64	0/64	0/9	0/6
Supraventricular TachycardiaCardiac disorders	0/64	1/64	0/9	0/6
Discoloured VomitGastrointestinal disorders	1/64	0/64	0/9	0/6
Catheter Site HaematomaGeneral disorders	1/64	0/64	0/9	0/6

Most frequent other events

Showing 10 of 41

Most frequent other events
Event	Double-blind Period: Placebo	Double-blind Period: Selexipag	Open Label Period: Selexipag (Ex-Placebo)	Open Label Period: Selexipag (Ex-Selexipag)
HeadacheNervous system disorders	14/64	36/64	6/9	2/6
DiarrhoeaGastrointestinal disorders	9/64	38/64	5/9	1/6
MyalgiaMusculoskeletal and connective tissue disorders	5/64	7/64	4/9	0/6
NauseaGastrointestinal disorders	4/64	17/64	3/9	1/6
VomitingGastrointestinal disorders	1/64	11/64	3/9	1/6
ArthralgiaMusculoskeletal and connective tissue disorders	4/64	14/64	3/9	1/6
Pain in JawMusculoskeletal and connective tissue disorders	2/64	16/64	2/9	0/6
Covid-19Infections and infestations	4/64	5/64	2/9	0/6
DizzinessNervous system disorders	7/64	8/64	2/9	0/6
Pain in ExtremityMusculoskeletal and connective tissue disorders	4/64	13/64	1/9	1/6

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
<=18 years	0	0	0
Between 18 and 65 years	24	36	60
>=65 years	40	28	68

Age, Continuous
Age, Continuous(years)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
Mean	64 ± 13.22	62 ± 14.38	63 ± 13.8

Sex: Female, Male
Sex: Female, Male(Participants)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
Female	47	46	93
Male	17	18	35

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
Hispanic or Latino	10	8	18
Not Hispanic or Latino	54	55	109
Unknown or Not Reported	0	1	1

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
American Indian or Alaska Native	1	0	1
Asian	12	7	19
Black or African American	3	2	5
Native Hawaiian or Other Pacific Islander	0	0	0
White	46	52	98
More than one race	0	0	0
Unknown or Not Reported	0	1	1
Other	2	2	4

Region of Enrollment
Region of Enrollment(Participants)	Double-blind Period: Placebo	Double-blind Period: Selexipag	Total
ARGENTINA	0	2	2
AUSTRALIA	1	3	4
BELGIUM	0	1	1
BRAZIL	5	6	11
BULGARIA	1	3	4
CANADA	0	1	1
CHINA	0	2	2
CZECH REPUBLIC	1	2	3
DENMARK	4	3	7
GERMANY	6	9	15
HUNGARY	0	1	1
ISRAEL	2	0	2
ITALY	2	3	5
MEXICO	4	1	5
POLAND	2	2	4
PORTUGAL	5	1	6
RUSSIAN FEDERATION	4	3	7
SLOVAKIA	0	1	1
SOUTH KOREA	7	2	9
SPAIN	1	0	1
SWEDEN	0	1	1
TAIWAN	1	1	2
THAILAND	4	2	6
TURKEY	4	4	8
UKRAINE	0	1	1
UNITED KINGDOM	5	6	11
UNITED STATES	5	3	8

Study locations

162 sites

University of California San Diego Medical Center
La Jolla, California 92037, United States
University of Southern California, Keck School of Medicine
Los Angeles, California 90033, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045, United States
Colorado Springs Pulmonary Consultants
Colorado Springs, Colorado 80907, United States
South Denver Cardiology Associates PC
Littleton, Colorado 80120, United States
Mayo Clinic in Florida
Jacksonville, Florida 32259, United States
Piedmont Healthcare
Atlanta, Georgia 30309, United States
Emory University
Atlanta, Georgia 30322, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611, United States
University of Chicago Hospitals - Chicago
Chicago, Illinois 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois 60453, United States
University of Maryland
Baltimore, Maryland 21201, United States
University of Michigan
Ann Arbor, Michigan 48109, United States
Sparrow Clinical Research Institute
Lansing, Michigan 48912, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
Washington University in St. Louis
Saint Louis, Missouri 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska 68198, United States
St. Mary's Cardiology
Reno, Nevada 89503, United States
University of New Mexico Clinical & Translational Science Center
Albuquerque, New Mexico 87131, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Temple University Hospital
Philadelphia, Pennsylvania 19140-5103, United States
Allegheny
Pittsburgh, Pennsylvania 15212, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213, United States
University of Texas Southwestern Medical Center
Dallas, Texas 75390, United States
Houston Methodist Hospital
Houston, Texas 77030, United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas 75093, United States
Intermountain Medical Center
Murray, Utah 84175, United States
University of Utah Cardiovascular Center
Salt Lake City, Utah 84132, United States
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin 53211, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin 53215, United States
Sanatorio de la Trinidad Mitre
Buenos Aires, C1039AAO, Argentina
Hospital Italiano de Buenos Aires
Caba, 1199ABB, Argentina
Sanatorio Ramon Cereijo
Caba, C1048AAN, Argentina
Instituto de Cardiología y Cirugía Cardiovascular - Fundación Favaloro
Caba, C1093AAS, Argentina
Hospital General de Agudos Dr Cosme Argerich
Caba, C1155AHD, Argentina
Hospital Britanico de Buenos Aires
Caba, C1280AEB, Argentina
Centro Médico Dra. De Salvo
Ciudad Autónoma de Buenos Aires, C1426ABP, Argentina
Royal Adelaide Hospital
Adelaide, 5000, Australia
Queensland Lung Transplant Service
Chermside, 4032, Australia
St Vincent's hospital
Darlinghurst, 2010, Australia
Pulmonary Arterial Hypertension Clinic
Hobart, 7000, Australia
The Alfred Hospital
Melbourne, 3004, Australia
Westmead Hospital
Westmead, 2145, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Medical University Vienna
Vienna, 1090, Austria
ULB Hôpital Erasme
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100, Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, 30441-070, Brazil
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)
Botucatu, 18618-686, Brazil
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes
Fortaleza, 60840-285, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiania, 74605-020, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90020-090, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Fundacao do ABC - Centro Universitario FMABC
Santo Andre, 09060-870, Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
Sao Paulo, 04037-003, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Sao Paulo, 05403-000, Brazil
UMHAT 'Heart and Brain Center for Excellence'
Pleven, 5800, Bulgaria
National Cardiology Hospital
Sofia, 1392, Bulgaria
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, 1750, Bulgaria
University Of Calgary - Peter Lougheed Centre
Calgary, Alberta T1Y 6J4, Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario N6A 5W9, Canada
Jewish General Hospital
Montreal, Quebec H3T 1E2, Canada
Institut Universitaire De Cardiologie Et De Pneumologie De Québec
Quebec, G1V 4G5, Canada
Chinese Academy of Medical Sciences(CAMS) & Peking Union Medical College(PUMC)
Beijing, 100730, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
The General Hospital of Northern Theater Command
Shenyang, 110000, China
Shengjing Hospital Of China Medical University
Shenyang, 110022, China
Shanxi Cardiovascular Hospital
Taiyuan, 030001, China
Tianjin Medical University General Hospital
Tian Jin, 300052, China
General University Hospital II.department of Internal Medicine-cardiology and angiology
Praha 2, 128 08, Czechia
Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
Arhus, 8200, Denmark
Rigshospitalet Kardiologisk Klinisk
Copenhagen, 2100, Denmark
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
Dresden, 01307, Germany
Universitätsklinikum Giessen Medizinische Klinik Und Poliklinik Ii, Pneumologie
Giessen, 35392, Germany
Universität Greifswald - Klinik Für Innere Medizin Bereich Pneumologie/Infektiologie
Greifswald, 17475, Germany
Universitätsklinikum Hamburg-Eppendorf - Pneumologie
Hamburg, 20246, Germany
Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie
Hannover, 30625, Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, 69126, Germany
Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
Homburg/Saar, 66421, Germany
Universitätsklinikum Leipzig Medizinischen Klinik und Poliklinik I, Abteilung für Pneumologie
Leipzig, 04103, Germany
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, 97074, Germany
Semmelweis Egyetem,Pulmonológiai Klinika
Budapest, 1083, Hungary
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály
Budapest, 1096, Hungary
Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum
Debrecen, 4032, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, 7624, Hungary
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
Szeged, 6720, Hungary
Rabin Medical Center Beilinson Campus
Petah Tikva, 4941492, Israel
The Chaim Sheba Medical Center
Tel-Hashomer, 5265601, Israel
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Policlinico Umberto I
Roma, 00161, Italy
Ospedale di Cattinara - Struttura complessa di Pneumologia
Trieste, 34149, Italy
Pusan National University Hospital
Busan, 49241, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul, 03722, Korea, Republic of
Asan Medical Center
Seoul, 05505, Korea, Republic of

Showing the first 100 of 162 sites across 31 countries.

References and documents

Study documents

Study protocol · Sep 29, 2020
Statistical analysis plan · Jul 11, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03689244
Lead sponsor: Actelion
Responsible party: Sponsor
First posted: Sep 28, 2018
Start date: Jan 23, 2019
Primary completion: Jun 7, 2022
Completion: Jun 7, 2022
Results posted: Aug 9, 2023
Last update: Jun 21, 2024

Study contacts

Julian Borissoff, MD, PhD

study director · Actelion

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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