A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
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.
Status: Completed (Phase 2). Started on September 1st, 2003.
Enrollment: 253 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator)
- Primary Purpose: Treatment
Conditions:
Interventions:
- Drug: PG-116800 (given as PG-530742)
- Drug: Placebo tablet
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 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
- Mininum Age
18 Years
- Maximum Age
80 Years
- Healthy Volunteers
No
Resources
Source: Warner Chilcott
Authority: United States: Food and Drug Administration
Locations
-
University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
Little Rock
Arkansas
72205
United States
-
Mercy Community Medical Center
Merced
California
95340
United States
-
Porter Adventist Hospital
Denver
Colorado
80210
United States
-
University of Connecticut Health Center
Farmington
Connecticut
06030-2202
United States
-
JFK Medical Center
Atlantis
Florida
33462
United States
-
Morton Plant Hospital
Clearwater
Florida
33756
United States
-
Piedmont Hospital
Atlanta
Georgia
30309
United States
-
Henry Ford Hospital
Detroit
Michigan
48202
United States
-
Abbott-Northwestern Hospital
Minneapolis
Minnesota
55407-1139
United States
-
Barnes Jewish Hospital
St. Louis
Missouri
63110
United States
-
Strong Memorial Hospital
Rochester
New York
14642
United States
-
Presbyterian Hospital
Charlotte
North Carolina
28204
United States
-
Moses Cone Hospital
Greensboro
North Carolina
27401
United States
-
Oklahoma Heart Hospital
Oklahoma City
Oklahoma
73120
United States
-
Westmoreland Regional Hospital
Greensburg
Pennsylvania
15601-2745
United States
-
Hershey Medical Center
Hershey
Pennsylvania
17033-0850
United States
-
Rhode Island Hospital
Providence
Rhode Island
02903
United States
-
Medical University of South Carolina
Charleston
South Carolina
29403
United States
-
Memorial Hospital
Chattanooga
Tennessee
37404-1127
United States
-
Memorial Hermann Hospital
Houston
Texas
77030
United States
-
West Virginia University Hospital
Morgantown
West Virginia
26506-9157
United States
-
Foothills Hospital
Calgary
Alberta
T2N 4N1
Canada
-
Grey Nuns Hospital
Edmonton
Alberta
T6L 5X8
Canada
-
University of Alberta Hospital
Edmonton
Alberta
T6G 2B7
Canada
-
Royal Alexandra Hospital
Edmonton
Alberta
T5G 3C8
Canada
-
Alder Medical Centre
Campbell River
British Columbia
V9W 5Y4
Canada
-
Vancouver General Hospital
Vancouver
British Columbia
V5Z 4E3
Canada
-
Victoria Heart Institute
Victoria
British Columbia
V8R 4R2
Canada
-
St. John's HSC
St. John's
New Brunswick
A1B 3V6
Canada
-
Queen Elizabeth II HSC
Halifax
Nova Scotia
B3H 3H7
Canada
-
Southlake Regional HC
Newmarket
Ontario
L3Y 2R2
Canada
-
Scarborough Grace Hospital
Scarborough
Ontario
M1S 4V5
Canada
-
St. Michael's Hospital
Toronto
Ontario
M5B 1W8
Canada
-
Toronto East General
Toronto
Ontario
M4C 3E7
Canada
-
CHUS, Hopital Fleurimont
Fleurimont
Quebec
J1H 5N4
Canada
-
Montreal General Hospital
Montreal
Quebec
H3G 1A4
Canada
-
Montreal Heart Institute
Montreal
Quebec
H1T 1C8
Canada
-
Hopital Sacre-Coeur
Montreal
Quebec
H4J 1C5
Canada
-
McGill University Health Centre, Royal Victoria Hospital
Montreal
Quebec
H3A 1A1
Canada
-
Hopital Laval
Ste-Foy
Quebec
G1V 4G5
Canada
-
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
-
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
Krakow
Poland
-
Klinika Chorob Serca i Naczyn, Krakowski 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
-
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warszawa
Poland
-
Klinika Kardiologii, Szpital Grochowski
Warszawa
Poland
-
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warszawa
Poland
-
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warszawa
Poland
Officials
Jose Brum, MD (Study Director, Procter and Gamble)
Sponsors
Warner Chilcott (Lead Sponsor)
References
None.
Links
None.
- Date Verified
- March 1st, 2010
- First Received
- March 22nd, 2010
- Last Changed
- March 22nd, 2010
Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.
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