NCT00984802

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

A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Ischemix, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2009-09-25
• Last updated: 2011-06-20

Locations

5 sites across 2 countries: United States, India