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Home > "S" Clinical Trials Conditions > Study of Oral PG-116800 Following a Heart Attack Study of Oral PG-116800 Following a Heart Attack
Study of Oral PG-116800 Following a Heart Attack
For Condition: Heart Failure,Heart Enlargement,Myocardial Infarction
Status: Completed
Sponsor(s): Procter & Gamble Pharmaceuticals ,
Synopsis: 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 possble 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment:
Location and Contact Information:
Alder Medical Centre
Campbell River, British Columbia, V9W 5Y4
Canada
Southlake Regional HC
Newmarket, Ontario, L3Y 2R2
Canada
Queen Elizabeth II HSC
Halifax, Nova Scotia, B3H 3H7
Canada
Moses Cone Hospital
Greensboro, North Carolina, 27401
United States
Scarborough Grace Hospital
Scarborough, Ontario, M1S 4V5
Canada
CHUS, Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Memorial Hermann Hospital
Houston, Texas, 77030
United States
Grey Nuns Hospital
Edmonton, Alberta, T6L 5X8
Canada
Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
Krakow, ,
Poland
Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
Lodz, ,
Poland
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
Szczecin, ,
Poland
Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warszawa, ,
Poland
Toronto East General
Toronto, Ontario, M4C 3E7
Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Canada
West Virginia University Hospital
Morgantown, West Virginia, 26506-9157
United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-2202
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407-1139
United States
Mercy Community Medical Center
Merced, California, 95340
United States
University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
Little Rock, Arkansas, 72205
United States
Hopital Laval
Ste Foy, Quebec, G1V 4G5
Canada
Strong Memorial Hospital
Rochester, New York, 14642
United States
I Klinika Kardilogii Akademii Medycznej w Poznaniu
Poznan, ,
Poland
JFK Medical Center
Atlantis, Florida, 33462
United States
1 Katedra Kardiologii Slaskiej Akademii Medycznej
Katowice, ,
Poland
Barnes Jewish Hospital
St. Louis, Missouri, 63110
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Memorial Hospital
Chattanooga, Tennessee, 37404-1127
United States
Westmoreland Regional Hospital
Greensburg, Pennsylvania, 15601-2745
United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
United States
Foothills Hospital
Calgary, Alberta, T2N 4N1
Canada
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warszawa, ,
Poland
Hopital Sacre-Coeur
Montreal, Quebec, H4J 1C5
Canada
Presbyterian Hospital
Charlotte, North Carolina, 28204
United States
Royal Alexandra Hospital
Edmonton, Alberta, T5G 3C8
Canada
Victoria Heart Institute
Victoria, British Columbia, V8R 4R2
Canada
Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
Bydgoszcz, ,
Poland
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Canada
Morton Plant Hospital
Clearwater, Florida, 33756
United States
Klinika Kardiologii, Szpital Grochowski
Warszawa, ,
Poland
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Medical University of South Carolina
Charleston, South Carolina, 29403
United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E3
Canada
Porter Adventist Hospital
Denver, Colorado, 80210
United States
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Canada
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
Krakow, ,
Poland
Piedmont Hospital
Atlanta, Georgia, 30309
United States
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Canada
Klinika Kardiologii, Panstwowy Szpital Kliniczny
Bialystok, ,
Poland
St. John's HSC
St. John's, Newfoundland and Labrador, A1B 3V6
Canada
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warszawa, ,
Poland
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Canada
Additional Information:
Study ID Numbers: 2002135;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067236
Other Heart Enlargement Studies:
1. Homocyst(e)ine, Vitamin Status, and CVD Risk
2. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)
3. Survival After Myocardial Infarction in A Biethnic Texas Community (Corpus Christi Heart Project)
4. Montreal Heart Attack Readjustment Trial (M-HART)
5. Stanford Five-City Multifactor Risk Reduction Study
Related Studies:
Other Heart Enlargement Clinical Trials
Other New York Clinical Trials
Other Rochester Clinical Trials
Study of Oral PG-116800 Following a Heart Attack
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