A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
Overview
- Phase
- Phase 2
- Intervention
- PG-116800 (given as PG-530742)
- Conditions
- Myocardial Infarction
- Sponsor
- Procter and Gamble
- Enrollment
- 253
- Locations
- 52
- Primary Endpoint
- Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PG-116800 tablet
PG-116800 tablet (200 mg) taken twice daily for 90 days
Intervention: PG-116800 (given as PG-530742)
Placebo tablet
Placebo tablet taken twice daily for 90 days
Intervention: Placebo tablet
Outcomes
Primary Outcomes
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
Time Frame: 90 days
Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)