Study of Oral PG-116800 Following a Heart Attack
|Myocardial Infarction Heart Failure Heart Enlargement||Drug: PG-116800 (given as PG-530742) Drug: Placebo tablet||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack|
- 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)
|Study Start Date:||September 2003|
|Study Completion Date:||December 2004|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
Experimental: PG-116800 tablet
PG-116800 tablet (200 mg) taken twice daily for 90 days
Drug: PG-116800 (given as PG-530742)
200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
Placebo Comparator: Placebo tablet
Placebo tablet taken twice daily for 90 days
Drug: Placebo tablet
placebo tablet, twice a day for 90 days
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067236
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|Study Director:||Jose Brum, MD||Procter and Gamble|