PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: PAH

In brief

This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.

Key facts

Study ID

NCT03449524

Run by

Complexa, Inc.

People needed

69

Starts

2018-08-01

Expected to finish

2020-08-05

Last updated by the study team

2020-08-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between 18 to 80 years of age inclusive at Screening
• 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)

You may not qualify if…

• Contraindications for CMRI imaging
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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