NCT00067236

Study of Oral PG-116800 Following a Heart Attack

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Procter and Gamble · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage. The main purpose of the study is to test whether a possible new drug (called PG-116800) that interferes with the MMP enzyme 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. This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick people with the drug to see if it works. The study is interventional since we will be using a drug to interfere with the heart tissue damage that follows a heart attack.

Conditions

• Myocardial Infarction
• Heart Failure
• Heart Enlargement

Interventions

Type	Name	Description
DRUG	PG-116800 (given as PG-530742)	200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
DRUG	Placebo tablet	placebo tablet, twice a day for 90 days

Timeline

• Start date: 2003-09-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2003-08-14
• Last updated: 2011-11-04
• Results posted: 2011-11-04

Locations

52 sites across 3 countries: United States, Canada, Poland