PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT03449524
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
69 participants
INTERVENTIONAL
2018-08-01
2020-08-05
Brief Summary
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Detailed Description
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The study will be performed in approximately 50 study centers across the United States of America and Europe. The recruitment period is anticipated to be approximately 24 months. Approximately 115 subjects will be enrolled to ensure at least 96 subjects complete the study.
Study participation for each subject will last approximately 8 months. The study will consist of a screening period (within 30 days prior to dosing), 180 days (approximately 6 months) treatment period and approximately 14 days follow-up period after the end of treatment visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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75mg CXA-10
Once daily dosing of 75mg CXA-10 in the morning
75mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
150mg CXA-10
Once daily dosing of 150mg CXA-10 in the morning
150mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
Placebo
Once daily dosing in the morning
Placebo
Placebo
Interventions
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75mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
150mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Weight ≥40 kg
* Must have a diagnosis of WHO Group 1 PH
* Have a World Health Organization (WHO) Classification of Functional Status Class II or III of patients with PH
* Must meet hemodynamic criteria by means of a right heart catheterization
* Meet pulmonary function test parameters
* A 6 MWD test of ≥125m and ≤550m at the visit
* Subjects must have a resting arterial oxygen saturation (SaO2) ≥90%, with or without supplemental oxygen, as measured by pulse oximetry at Screening
* Subjects enrolled in a prescribed exercise program for pulmonary rehabilitation must be in a stable program for 3 months prior to Screening (Visit 1) and must agree to maintain their current level of rehabilitation throughout the study. If subjects are not enrolled in a prescribed exercise training program for pulmonary rehabilitation, they cannot enroll during the Screening/Baseline Period or throughout the study
* If receiving simvastatin-containing products: dose should not exceed 20 mg/day
* Subjects must be receiving no more than three of the following previously approved PAH therapies: phosphodiesterase type 5 (PDE-5) inhibitors, endothelin receptor antagonist (ERA), soluble guanylate cyclase (sGC) stimulator, prostanoids, prostacyclin receptor agonists and must be on stable doses (≥3 months) at Screening (Visit 1)
Exclusion Criteria
* WHO Groups 2, 3, 4 and 5 Pulmonary Hypertension
* Unrepaired congenital heart defects and significant congenital heart defects (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) repaired less than 1 year prior to Screening (Visit 1) (Group 1 classification of Pulmonary Hypertension)
* QTcF \> 500 msec
* Acute myocardial infarction or acute coronary syndrome within the last 90 days
* Cerebrovascular accident/transient ischemic attack (CVA/TIA) within the last 90 days
* Hospitalization for left heart failure within the last 90 days
* Clinically significant aortic or mitral valve disease defined as greater than mild regurgitation or mild stenosis; pericardial constriction; restrictive or constrictive cardiomyopathy; left ventricular dysfunction (LVEF \< 50%); left ventricular outflow obstruction; symptomatic coronary artery disease; autonomic hypotension; or fluid depletion
* Chronic atrial fibrillation and life-threatening cardiac arrhythmias
* Personal or family history of congenital prolonged QTc syndrome or sudden or sudden unexpected death due to a cardiac reason
* Clinically significant anemia
* Severe hepatic impairment or active chronic hepatitis
* Receiving intravenous inotropes within 2 weeks prior to Screening
* History of angina pectoris or other condition that was treated with long or short acting nitrates \<12 weeks of Screening
* Received prednisone doses \>15mg/day or changes in immunosuppressive medications \< 12 weeks prior to Screening (Visit 1)
* Recent (within 1 year) history of abusing alcohol or illicit drugs.
* History of any primary malignancy, with no evidence of disease for at least 5 years
* Treatment with any investigational drug or device within 30 days or 5 half-lives
18 Years
80 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
Philips Healthcare
INDUSTRY
Cardiovascular Clinical Sciences Inc
INDUSTRY
MicroConstants
UNKNOWN
Innovative Analytics
UNKNOWN
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
Complexa, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Theo Danoff, MD
Role: STUDY_DIRECTOR
Complexa, Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Health
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Washington Hospital (Medstar)
Washington D.C., District of Columbia, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Florida Health
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
AdventHealth
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Kansas City, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Minnesotta
Minneapolis, Minnesota, United States
Washington University and Barnes Jewish Hospital
St Louis, Missouri, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Christ Hospital-Lindner Research Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Penn State M.S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Vanderbuilt University
Nashville, Tennessee, United States
UT Southwestern
Dallas, Texas, United States
Texas Tech
El Paso, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Inova Medical Campus
Falls Church, Virginia, United States
Sentara Medical Group
Norfolk, Virginia, United States
Froedert Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Royal Free
London, , United Kingdom
Royal Brompton
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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CXA-10-301
Identifier Type: -
Identifier Source: org_study_id
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