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

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ClinicalTrials.gov Identifier: NCT04435782
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Actelion

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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: JNJ-67896049 Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 14, 2023


Arm Intervention/treatment
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.
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.
Other Name: Selexipag




Primary Outcome Measures :
  1. Change from Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in RVSV in participants will be assessed by pulmonary artery flow MRI.


Secondary Outcome Measures :
  1. Change from Baseline to Week 26 in RV End-Diastolic Volume (RVEDV) Assessed by MRI [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in RVEDV will be assessed by MRI.

  2. Change from Baseline to Week 26 in RV End-Systolic Volume (RVESV) Assessed by MRI [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in RVESV will be assessed by MRI.

  3. Change from Baseline to Week 26 in RV Ejection Fraction (RVEF) Assessed by MRI [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in RVEF will be assessed by MRI.

  4. Change from Baseline to Week 26 in RV Mass Assessed by MRI [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in RV mass will be assessed by MRI.

  5. Change from Baseline to Week 26 RV Global Longitudinal Strain (RVGLS) Assessed by MRI [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 RVGLS will be assessed by MRI.

  6. Change of Baseline to Week 26 in World Health Organization Functional Class (WHO FC) [ Time Frame: Baseline and week 26 ]
    Change of baseline to week 26 in WHO FC in participants will be assessed.

  7. Change form Baseline to Week 26 in N-Terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 NT-proBNP in participants will be assessed.

  8. Change from Baseline to Week 26 in 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline and week 26 ]
    Change from baseline to week 26 in 6MWD in participants will be assessed.

  9. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 56 weeks ]
    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAE is any AE from first dose up to 3 days after end of study intervention.

  10. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 60 weeks ]
    A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  11. Number of Participants with AEs Leading to Premature Discontinuation of Selexipag [ Time Frame: Up to 52 weeks ]
    Number of participants with AEs leading to premature discontinuation of study drug Selexipag will be reported.

  12. Number of Participants with AEs of Special Interest [ Time Frame: Up to 60 weeks ]
    Number of participants with AEs of special interest will be reported.

  13. Number of Participants with Treatment-Emergent Marked Laboratory Abnormalities [ Time Frame: Up to 56 weeks ]
    Number of participants with treatment-emergent marked laboratory abnormalities will be reported.

  14. Change from Baseline to Week 26 in Number of Non-Invasive Low-Risk Criteria Variable [ Time Frame: Baseline to week 26 ]
    Change from baseline to Week 26 in number of non-invasive low-risk criteria among the following 8 variables: Absence of clinical signs of right heart failure; Absence of symptoms progression; Absence of syncope; World Health Organization functional class (WHO FC) I-II; 6-minute walking distance (6MWD) greater than (>) 440 meters (m); N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) less than (<) 300 nanogram per liters (ng/L); Right atrial (RA) area <18 centimeter square (cm^2), as determined by echocardiography (Echo) and Absence of pericardial effusion, as determined by Echo will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) more than (>) 300 nanogram per liter (ng/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 reliable 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) greater than or equal to (>=) 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 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 prior to Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435782


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Actelion
Investigators
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Study Director: Actelion Clinical Trial Actelion
Additional Information:
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Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT04435782    
Other Study ID Numbers: CR108753
67896049PAH4005 ( Other Identifier: Actelion )
2019-004783-22 ( EudraCT Number )
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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 Data Access (YODA) Project site at yoda.yale.edu.

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Actelion:
Right ventricle
Reverse remodeling
Magnetic resonance Imaging
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Ventricular Remodeling
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Selexipag
Antihypertensive Agents