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Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy

NCT00984802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2011-06-20

No results posted yet for this study

Summary

This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.

Conditions

  • Stable Coronary Artery Disease
  • Percutaneous Coronary Intervention

Interventions

DRUG

CMX-2043

Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.

DRUG

Placebo control

Vehicle solution for IV administration single dose.

Sponsors & Collaborators

  • Ischemix, LLC

    lead INDUSTRY

Principal Investigators

  • Alan S. Lader, Ph.D. · Ischemix, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-03-31
Completion
2011-04-30

Countries

  • United States
  • India

Study Locations

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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 NCT00984802 on ClinicalTrials.gov