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

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ClinicalTrials.gov Identifier: NCT03449524
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : October 28, 2019
Sponsor:
Collaborators:
Medpace, Inc.
Philips Healthcare
Cardiovascular Clinical Science Foundation
MicroConstants
Innovative Analytics
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Information provided by (Responsible Party):
Complexa, Inc.

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 age with PAH.

Condition or disease Intervention/treatment Phase
PAH Drug: 75mg CXA-10 Drug: 150mg CXA-10 Other: Placebo Phase 2

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 age with PAH.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CXA-10
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Active Comparator: 75mg CXA-10
Once daily dosing of 75mg CXA-10 in the morning
Drug: 75mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

Active Comparator: 150mg CXA-10
Once daily dosing of 150mg CXA-10 in the morning
Drug: 150mg CXA-10
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

Placebo Comparator: Placebo
Once daily dosing in the morning
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Right Ventricular Ejection Fraction (RVEF) [ Time Frame: 6 months ]
    • To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by right ventricular ejection fraction (RVEF) as measured by Cardiac MRI

  2. Pulmonary Vascular Resistance (PVR) [ Time Frame: 6 months ]
    • To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by pulmonary vascular resistance (PVR) as measured by right heart catheterization (RHC)


Secondary Outcome Measures :
  1. 6 Minute Walk Distance (6MWD) [ Time Frame: 6 months ]
    To determine the efficacy of oral doses of CXA-10 on stable background therapy administered for 6 months in subjects with PAH assessed by 6 minute walk distance (6MWD)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449524


Contacts
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Contact: Michael T Nelson, BA 484-329-8430 ext 48432998430 mike.nelson@complexarx.com

  Show 41 Study Locations
Sponsors and Collaborators
Complexa, Inc.
Medpace, Inc.
Philips Healthcare
Cardiovascular Clinical Science Foundation
MicroConstants
Innovative Analytics
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Investigators
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Study Director: Theo Danoff, MD Complexa, Inc.

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Responsible Party: Complexa, Inc.
ClinicalTrials.gov Identifier: NCT03449524     History of Changes
Other Study ID Numbers: CXA-10-301
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Complexa, Inc.:
Pulmonary Arterial Hypertension
Pulmonary Hypertension
PAH
Connective Tissue Disease-Associated
6 Minute Walk Test
6 Minute Walk Distance
Pulmonary Vascular Resistance
Cardiac MRI
Right Ventricular Function
Hypertension
Familial Primary Pulmonary Hypertension
Connective Tissue Diseases
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases