Study of Oral PG-116800 Following a Heart Attack - Full Text View

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00067236

Purpose

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.

Condition	Intervention	Phase
Myocardial Infarction Heart Failure Heart Enlargement	Drug: PG-116800 (given as PG-530742) Drug: Placebo tablet	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack Heart Failure

Drug Information available for: PG 116800

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

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

Enrollment:	253
Study Start Date:	September 2003
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo tablet twice daily for 90 days	Drug: Placebo tablet placebo tablet, twice a day for 90 days
2: Experimental PG-116800 tablet (200 mg) twice daily for 90 days	Drug: PG-116800 (given as PG-530742) 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067236

Hide Study Locations

Locations

United States, Arkansas
University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
Little Rock, Arkansas, United States, 72205
United States, California
Mercy Community Medical Center
Merced, California, United States, 95340
United States, Colorado
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-2202
United States, Florida
JFK Medical Center
Atlantis, Florida, United States, 33462
Morton Plant Hospital
Clearwater, Florida, United States, 33756
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407-1139
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, North Carolina
Moses Cone Hospital
Greensboro, North Carolina, United States, 27401
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Westmoreland Regional Hospital
Greensburg, Pennsylvania, United States, 15601-2745
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Tennessee
Memorial Hospital
Chattanooga, Tennessee, United States, 37404-1127
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
United States, West Virginia
West Virginia University Hospital
Morgantown, West Virginia, United States, 26506-9157
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 4N1
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5G 3C8
Canada, British Columbia
Victoria Heart Institute
Victoria, British Columbia, Canada, V8R 4R2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 4E3
Alder Medical Centre
Campbell River, British Columbia, Canada, V9W 5Y4
Canada, New Brunswick
St. John's HSC
St. John's, New Brunswick, Canada, A1B 3V6
Canada, Nova Scotia
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada, B3H 3H7
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Scarborough Grace Hospital
Scarborough, Ontario, Canada, M1S 4V5
Southlake Regional HC
Newmarket, Ontario, Canada, L3Y 2R2
Toronto East General
Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Hopital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
CHUS, Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
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
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
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warszawa, Poland
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
Szczecin, Poland
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warszawa, Poland
Klinika Kardiologii, Szpital Grochowski
Warszawa, Poland
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warszawa, Poland
I Klinika Kardilogii Akademii Medycznej w Poznaniu
Poznan, Poland

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Jose Brum, MD

Procter and Gamble

More Information

No publications provided

Responsible Party:	Procter and Gamble Pharmaceuticals ( Jose Brum, MD )
Study ID Numbers:	2002135
Study First Received:	August 13, 2003
Last Updated:	July 17, 2009
ClinicalTrials.gov Identifier:	NCT00067236 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Hypertrophy

Necrosis
Pathologic Processes
Cardiovascular Diseases
Infarction
Cardiomegaly
Myocardial Infarction

ClinicalTrials.gov processed this record on November 27, 2009