Study of Oral PG-116800 Following a Heart Attack

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00067236
First received: August 13, 2003
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Heart Failure
Heart Enlargement
Drug: PG-116800 (given as PG-530742)
Drug: Placebo tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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)


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
Experimental: PG-116800 tablet
PG-116800 tablet (200 mg) taken 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
Placebo Comparator: Placebo tablet
Placebo tablet taken twice daily for 90 days
Drug: Placebo tablet
placebo tablet, twice a day for 90 days

Detailed 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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Moses Cone Hospital
Greensboro, North Carolina, United States, 27401
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
Alder Medical Centre
Campbell River, British Columbia, Canada, V9W 5Y4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 4E3
Victoria Heart Institute
Victoria, British Columbia, Canada, V8R 4R2
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
Southlake Regional HC
Newmarket, Ontario, Canada, L3Y 2R2
Scarborough Grace Hospital
Scarborough, Ontario, Canada, M1S 4V5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Toronto East General
Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec
CHUS, Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hopital Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
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
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
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
ClinicalTrials.gov Identifier: NCT00067236     History of Changes
Other Study ID Numbers: 2002135
Study First Received: August 13, 2003
Results First Received: August 3, 2011
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiomegaly
Heart Failure
Hypertrophy
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014