Study of Oral PG-116800 Following a Heart Attack

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067236
• Other study ID #: 2002135
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2003
• Last updated: September 27, 2011
• Start date: September 2003
• Est. completion date: December 2004

Study information

• Verified date: September 2011
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 electrocardiogram (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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomegaly
• Heart Enlargement
• Heart Failure
• Myocardial Infarction

Intervention

Drug:
• PG-116800 (given as PG-530742)
200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
• Placebo tablet
placebo tablet, twice a day for 90 days

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	Alder Medical Centre	Campbell River	British Columbia
Canada	Grey Nuns Hospital	Edmonton	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	CHUS, Hopital Fleurimont	Fleurimont	Quebec
Canada	Queen Elizabeth II HSC	Halifax	Nova Scotia
Canada	Hopital Sacre-Coeur	Montreal	Quebec
Canada	McGill University Health Centre, Royal Victoria Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Southlake Regional HC	Newmarket	Ontario
Canada	Scarborough Grace Hospital	Scarborough	Ontario
Canada	St. John's HSC	St. John's	New Brunswick
Canada	Hopital Laval	Ste-Foy	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto East General	Toronto	Ontario
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute	Victoria	British Columbia
Poland	Klinika Kardiologii, Panstwowy Szpital Kliniczny	Bialystok
Poland	Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy	Bydgoszcz
Poland	1 Katedra Kardiologii Slaskiej Akademii Medycznej	Katowice
Poland	Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny	Krakow
Poland	Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny	Krakow
Poland	Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi	Lodz
Poland	I Klinika Kardilogii Akademii Medycznej w Poznaniu	Poznan
Poland	Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony	Szczecin
Poland	I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie	Warszawa
Poland	Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie	Warszawa
Poland	Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA	Warszawa
Poland	Klinika Kardiologii, Szpital Grochowski	Warszawa
United States	Piedmont Hospital	Atlanta	Georgia
United States	JFK Medical Center	Atlantis	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	Memorial Hospital	Chattanooga	Tennessee
United States	Morton Plant Hospital	Clearwater	Florida
United States	Porter Adventist Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Moses Cone Hospital	Greensboro	North Carolina
United States	Westmoreland Regional Hospital	Greensburg	Pennsylvania
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Hermann Hospital	Houston	Texas
United States	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	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	West Virginia University Hospital	Morgantown	West Virginia
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Strong Memorial Hospital	Rochester	New York
United States	Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)	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)	90 days	No