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

NCT03449524 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-08-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

75mg CXA-10

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

DRUG

150mg CXA-10

CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • Philips Healthcare

    collaborator INDUSTRY

  • Cardiovascular Clinical Sciences Inc

    collaborator INDUSTRY

  • MicroConstants

    collaborator UNKNOWN

  • Innovative Analytics

    collaborator UNKNOWN

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    collaborator OTHER

  • Complexa, Inc.

    lead INDUSTRY

Principal Investigators

  • Theo Danoff, MD · Complexa, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-08-05
Completion
2020-08-05
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03449524 on ClinicalTrials.gov