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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.
  • - 6-minute walking distance (6MWD) >=150 meter (m) during screening period.

Exclusion Criteria:

  • - Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog.
Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary if stopped > 6 months (180 days) prior to Day 1.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04435782
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Actelion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Actelion Clinical Trial
Principal Investigator Affiliation Actelion
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Argentina, Brazil, France, Germany, Hong Kong, Israel, Korea, Republic of, Malaysia, Netherlands, Russian Federation, Saudi Arabia, Singapore, United Arab Emirates, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University Of California San Diego, La Jolla, California

Status

Address

University Of California San Diego

La Jolla, California, 92093

AnMed Health, Anderson, South Carolina

Status

Address

AnMed Health

Anderson, South Carolina, 29621

UT Southwestern, Dallas, Texas

Status

Address

UT Southwestern

Dallas, Texas, 75231

International Sites

Hospital Italiano de Buenos Aires, Caba, Argentina

Status

Address

Hospital Italiano de Buenos Aires

Caba, , 1199ABB

Sanatorio Ramon Cereijo, Caba, Argentina

Status

Address

Sanatorio Ramon Cereijo

Caba, , C1048AAN

Instituto Cardiovascular de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Status

Address

Instituto Cardiovascular de Buenos Aires

Ciudad Autonoma Buenos Aires, , 1428

Associacao Hospitalar Moinhos de Vento, Porto Alegre, Brazil

Status

Address

Associacao Hospitalar Moinhos de Vento

Porto Alegre, , 90035-001

Porto Alegre, Brazil

Status

Address

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , 90035-074

Sao Paulo, Brazil

Status

Address

Hospital Das Clinicas Da Faculdade De Medicina Da USP

Sao Paulo, , 05403-000

São Paulo, Brazil

Status

Address

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

São Paulo, , 04024-002

CHU Grenoble, La Tronche, France

Status

Address

CHU Grenoble

La Tronche, , 38700

DRK Kliniken Westend, Berlin, Germany

Status

Address

DRK Kliniken Westend

Berlin, , 14050

Universitatsklinikum Bonn, Bonn, Germany

Status

Address

Universitatsklinikum Bonn

Bonn, , 53127

Mainz, Germany

Status

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Grantham Hospital, Hong Kong, Hong Kong

Status

Address

Grantham Hospital

Hong Kong, ,

Hong Kong, Hong Kong

Status

Address

Queen Mary Hospital, University of Hong Kong

Hong Kong, ,

Hadassah Medical Center, Jerusalem, Israel

Status

Address

Hadassah Medical Center

Jerusalem, ,

Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel

Status

Address

Rabin Medical Center, Beilinson Campus

Petah Tikva, , 4941492

Chungnam National University Hospital, Daejeon, Korea, Republic of

Status

Address

Chungnam National University Hospital

Daejeon, , 35015

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Address

Seoul National University Hospital

Seoul, , 03080

Asan Medical Center, Seoul, Korea, Republic of

Status

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Address

Samsung Medical Center

Seoul, , 06351

Institut Jantung Negara, Kuala Lumpur, Malaysia

Status

Address

Institut Jantung Negara

Kuala Lumpur, , 50400

VUMC Amsterdam, Amsterdam, Netherlands

Status

Address

VUMC Amsterdam

Amsterdam, , 1081 HV

Radboud Umcn, Nijmegen, Netherlands

Status

Address

Radboud Umcn

Nijmegen, , 6525 GA

Moscow, Russian Federation

Status

Address

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, , 121552

Federal State Budgetary Institution, St Petersburg, Russian Federation

Status

Address

Federal State Budgetary Institution

St Petersburg, , 197341

Riyadh, Saudi Arabia

Status

Address

King Faisal Specialist Hospital & Research Center

Riyadh, , 12713

National Heart Centre (NHC) Singapore, Singapore, Singapore

Status

Address

National Heart Centre (NHC) Singapore

Singapore, , 169609

Tan Tock Seng Hospital, Singapore, Singapore

Status

Address

Tan Tock Seng Hospital

Singapore, , 308433

Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates

Status

Address

Cleveland Clinic Abu Dhabi

Abu Dhabi, , 112412

Golden Jubilee National Hospital, Glasgow, United Kingdom

Status

Address

Golden Jubilee National Hospital

Glasgow, , G81 4HX

Royal Free Hospital, Hampstead, United Kingdom

Status

Address

Royal Free Hospital

Hampstead, , NW3 2QG

Sheffield, United Kingdom

Status

Address

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Sheffield, , S10 2RX

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

Submit Feedback

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation in a clinical trial or study.