Overview

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.