Study of Oral PG-116800 Following a Heart Attack

Phase 2

Completed

• Conditions: Heart Enlargement; Myocardial Infarction; Heart Failure
• Interventions: Drug: PG-116800 (given as PG-530742); Drug: Placebo tablet

• Registration Number: NCT00067236
• Lead Sponsor: Procter and Gamble

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.

Study Timeline

• Study First Submitted: 2003-08-13
• Study First Submitted QC: 2003-08-13
• Study First Posted: 2003-08-14
• Study Start: 2003-09
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Results First Submitted: 2011-08-03
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-27
• Last Update Submitted: 2011-09-27
• Results First Posted: 2011-11-04
• Last Update Posted: 2011-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PG-116800 tablet	PG-116800 (given as PG-530742)	PG-116800 tablet (200 mg) taken twice daily for 90 days
Placebo tablet	Placebo tablet	Placebo tablet taken twice daily for 90 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)	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)

Trial Locations

Locations (52)

University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System; 🇺🇸 Little Rock, Arkansas, United States

Mercy Community Medical Center; 🇺🇸 Merced, California, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

Piedmont Hospital; 🇺🇸 Atlanta, Georgia, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Abbott-Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States

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