A Study of Selexipag Assessing Right Ventricular Remodeling in Pulmonary Arterial Hypertension by Cardiac Magnetic Resonance Imaging

NCT04435782 | Terminated Phase 4 Results FDA Drug

• 3 other identifiers: CR10875367896049PAH40052019-004783-22
• Study Type: interventional
• Target: 9
• Locations: 15 countries
• Sites: 35

Brief Summary

The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH).

Conditions

Pulmonary Arterial Hypertension

Keywords

Right ventricle; Reverse remodeling; Magnetic resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)

  Change from baseline to Week 26 in RVSV assessed by pulmonary artery flow MRI was reported.

  Baseline, Week 26

Secondary Outcomes (14)

• Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI

  Baseline, Week 26

• Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI

  Baseline, Week 26

• Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI

  Baseline, Week 26

• Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI

  Baseline, Week 26

• Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI

  Baseline, Week 26

Study Arms (1)

JNJ-67896049

EXPERIMENTAL

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.

Drug: JNJ-67896049

Interventions

JNJ-67896049 DRUG

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.

Also known as: Selexipag

JNJ-67896049

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• World health organization functional class (WHO FC) II or III. Enrollment will be stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC III are expected to be approximately 40 percent (%) and 60%, respectively
• 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
• minute walking distance (6MWD) \>=150 meter (m) during screening period

You may not qualify if:

• 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

Sponsors & Collaborators

• Actelion: lead

Study Sites (35)

University Of California San Diego

La Jolla, California, 92093, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

UT Southwestern

Dallas, Texas, 75231, United States

Location

Hospital Italiano de Buenos Aires

Caba, 1199ABB, Argentina

Location

Sanatorio Ramon Cereijo

Caba, C1048AAN, Argentina

Location

Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma Buenos Aires, 1428, Argentina

Location

Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90035-074, Brazil

Location

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

São Paulo, 04024 002, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-000, Brazil

Location

CHU Grenoble

La Tronche, 38700, France

Location

DRK Kliniken Westend

Berlin, 14050, Germany

Location

Universitatsklinikum Bonn

Bonn, 53127, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Grantham Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital University of Hong Kong

Hong Kong, Hong Kong

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Rabin Medical Center Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

VUMC Amsterdam

Amsterdam, 1081 HV, Netherlands

Location

Radboud Umcn

Nijmegen, 6525 GA, Netherlands

Location

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, 121552, Russia

Location

Federal State Budgetary Institution

Saint Petersburg, 197341, Russia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, 12713, Saudi Arabia

Location

National Heart Centre (NHC) Singapore

Singapore, 169609, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Cleveland Clinic Abu Dhabi

Abu Dhabi, 112412, United Arab Emirates

Location

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

Royal Free Hospital

Hampstead, NW3 2QG, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Sheffield, S10 2RX, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

selexipag

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Responsible Scientist
• Organization: Actelion Pharmaceuticals Ltd

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Actelion Clinical Trial

  Actelion

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: July 7, 2021
• Primary Completion: July 28, 2023
• Study Completion: July 28, 2023
• Last Updated: March 30, 2025
• Results First Posted: August 20, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); MY (1); IL (2); DE (3); FR (1); KR (5); US (3); SG (2); GB (3); AR (3); NL (2); BR (4); AE (1); SA (1); RU (2)