A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging
NCT ID: NCT04435782
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
9 participants
INTERVENTIONAL
2021-07-07
2023-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JNJ-67896049
Participants will receive JNJ-67896049 tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
JNJ-67896049
Participants will receive tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
Interventions
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JNJ-67896049
Participants will receive tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to 6th world symposium of pulmonary hypertension (WSPH) classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH associated with connective tissue disease, e) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
* Patients already receiving PAH-specific oral mono or dual therapy (that is, phosphodiesterase type 5 inhibitors \[PDE-5i\] or soluble guanylate cyclase stimulators \[sGCs\] and/or endothelin receptor antagonist \[ERA\]) or patients who are not candidates for these therapies
* N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) greater than or equal to (\>=) 300 nanograms per liter (ng/L) (greater than or equal to \[\>=\] 300 picograms per milliliter \[pg/mL\]; \>=35.5 picomoles per liter \[pmol/L\]) at screening
* Women of childbearing potential must meet the following criteria: a) Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b) Agree to use acceptable methods of contraception from Day 1 to at least 30 days after study intervention discontinuation, c) If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly pregnancy tests to at least 30 days after study intervention discontinuation
* 6-minute walking distance (6MWD) \>=150 meter (m) during screening period
Exclusion Criteria
* Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 4 weeks (28 days) prior to Day 1
* Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
* Severe coronary heart disease or unstable angina
* Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months (90 days) prior to Day 1
18 Years
64 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Actelion Clinical Trial
Role: STUDY_DIRECTOR
Actelion
Locations
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University Of California San Diego
La Jolla, California, United States
AnMed Health
Anderson, South Carolina, United States
UT Southwestern
Dallas, Texas, United States
Hospital Italiano de Buenos Aires
Caba, , Argentina
Sanatorio Ramon Cereijo
Caba, , Argentina
Instituto Cardiovascular de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Associacao Hospitalar Moinhos de Vento
Porto Alegre, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
CHU Grenoble
La Tronche, , France
DRK Kliniken Westend
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Grantham Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital University of Hong Kong
Hong Kong, , Hong Kong
Hadassah Medical Center
Jerusalem, , Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, , Israel
Institut Jantung Negara
Kuala Lumpur, , Malaysia
VUMC Amsterdam
Amsterdam, , Netherlands
Radboud Umcn
Nijmegen, , Netherlands
National Medical Research Center of Cardiology of MoH of Russian Federation
Moscow, , Russia
Federal State Budgetary Institution
Saint Petersburg, , Russia
King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
National Heart Centre (NHC) Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Chungnam National University Hospital
Daejeon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Cleveland Clinic Abu Dhabi
Abu Dhabi, , United Arab Emirates
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Royal Free Hospital
Hampstead, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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67896049PAH4005
Identifier Type: OTHER
Identifier Source: secondary_id
2019-004783-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108753
Identifier Type: -
Identifier Source: org_study_id
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