Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
253 participants
INTERVENTIONAL
2003-09-30
2004-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PG-116800 tablet
PG-116800 tablet (200 mg) taken twice daily for 90 days
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 taken twice daily for 90 days
Placebo tablet
placebo tablet, twice a day for 90 days
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Principal Investigators
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Jose Brum, MD
Role: STUDY_DIRECTOR
Procter and Gamble
Locations
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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
Strong Memorial Hospital
Rochester, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Moses Cone Hospital
Greensboro, North Carolina, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Memorial Hospital
Chattanooga, Tennessee, United States
Memorial Hermann Hospital
Houston, Texas, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Grey Nuns Hospital
Edmonton, Alberta, Canada
Alder Medical Centre
Campbell River, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute
Victoria, British Columbia, Canada
St. John's HSC
Saint John's, New Brunswick, Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
Southlake Regional HC
Newmarket, Ontario, Canada
Scarborough Grace Hospital
Scarborough Village, Ontario, Canada
Toronto East General
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
CHUS, Hopital Fleurimont
Fleurimont, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Hopital Sacre-Coeur
Montreal, Quebec, Canada
Hopital Laval
Ste-Foy, Quebec, Canada
Klinika Kardiologii, Panstwowy Szpital Kliniczny
Bialystok, Bialystok, Poland
Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
Bydgoszcz, Bydgoszcz, Poland
1 Katedra Kardiologii Slaskiej Akademii Medycznej
Katowice, Katowice, Poland
Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
Krakow, Krakow, Poland
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
Krakow, Krakow, Poland
I Klinika Kardilogii Akademii Medycznej w Poznaniu
Poznan, Poznan, Poland
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
Szczecin, Szczecin, Poland
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warsaw, Warszawa, Poland
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warsaw, Warszawa, Poland
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warsaw, Warszawa, Poland
Klinika Kardiologii, Szpital Grochowski
Warsaw, Warszawa, Poland
Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
Lodz, Łódź Voivodeship, Poland
Countries
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Other Identifiers
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2002135
Identifier Type: -
Identifier Source: org_study_id