Status:
TERMINATED
PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Complexa, Inc.
Collaborating Sponsors:
Medpace, Inc.
Philips Healthcare
Conditions:
PAH
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ag...
Detailed Description
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 ag...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2020
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03449524
Start Date
August 1 2018
End Date
August 5 2020
Last Update
August 10 2020
Active Locations (46)
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1
University of Alabama
Birmingham, Alabama, United States, 35233
2
Arizona Pulmonary Specialists
Phoenix, Arizona, United States, 85012
3
University of Arizona
Tucson, Arizona, United States, 85724
4
University of California San Francisco
San Francisco, California, United States, 94143-2202