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Active Clinical Trials

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

Active NCT:
03449524
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Complexa, Inc.
Contact: 

For more information, please contact Matthew Yeager at 412-359-8468 or Matthew.Yeager@ahn.org.

Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects with Pulmonary Arterial Hypertension (PAH) (CXA-10-301)

Purpose: 

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.

Ages Eligible for Study:  18 Years to 80 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

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 two 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:

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

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

Subject has taken immunosuppressant therapy < 12 weeks prior to Screening

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