Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

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

Keywords

Pulmonary Arterial Hypertension Right ventricle Reverse remodeling Magnetic resonance Imaging Familial Primary Pulmonary Hypertension Hypertension Ventricular Remodeling Selexipag JNJ-67896049

Eligibility

You can join if…

Open to people ages 18-65

  • World health organization function class (WHO FC) II or III
  • Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to classification: a) Idiopathic PAH, b) Heritable PAH, c) PAH associated with connective tissue disease, d) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
  • For participants already receiving PAH-specific therapy, the PAH treatment dose must have been stable for at least 3 months before informed consent form (ICF) signature, and until Day 1
  • N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) more than (>) 300 nanogram per milliliter (ng/mL) 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 up to 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 up to 30 days after study intervention discontinuation

You CAN'T join if...

  • 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

Locations

  • University Of California San Diego
    La Jolla California 92093 United States
  • University of California at San Francisco
    San Francisco California 94115 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT04435782
Phase
Phase 4
Study Type
Interventional
Last Updated