Study of Oral PG-116800 Following a Heart Attack - Tabular View

Tracking Information

First Received Date ^ICMJE

August 13, 2003

Last Updated Date

July 17, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prevented left ventricular end-diastolic volume index augmentation 90 days post MI [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00067236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Oral PG-116800 Following a Heart Attack

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Myocardial Infarction
Heart Failure
Heart Enlargement

Intervention ^ICMJE

Drug: PG-116800 (given as PG-530742)
Drug: Placebo tablet

Study Arms / Comparison Groups

Placebo Comparator: Placebo tablet twice daily for 90 days
Experimental: PG-116800 tablet (200 mg) twice daily for 90 days

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

253

Completion Date

December 2004

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Poland

Administrative Information

NCT ID ^ICMJE

NCT00067236

Responsible Party

Jose Brum, MD, Procter and Gamble Pharmaceuticals

Study ID Numbers ^ICMJE

2002135

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jose Brum, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP