Study of Oral PG-116800 Following a Heart Attack

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Procter and Gamble

Criteria

Inclusion:

• Be at least 18 years of age but not older than 80 years of age at screening;

• Be diagnosed with a heart attack based on electrocardiogram (ECG) and cardiac enzymes criteria;

• The qualifying heart attack has to be a first heart attack;

• The qualifying heart attack has to result in a left ventricular ejection fraction (a measure of the working efficiency of the heart) between 15% and 40%.

Exclusion:

• Documented previous history of heart attack;

• Any past history of heart failure;

• Hemodynamic instability (no instability of circulatory system);

• History of congenital heart disease and cardiomyopathy (weakened heart muscle) associated with connective tissue disorders;

• Recent history or current moderate-to-severe kidney or liver impairment;

• Significant blood dyscrasias (disorders of the blood cells);

• Females who are currently: pregnant; breast-feeding; or are of childbearing potential.