Study of Oral PG-116800 Following a Heart Attack

September 27, 2011 updated by: Procter and Gamble

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PG-116800 tablet
PG-116800 tablet (200 mg) taken twice daily for 90 days
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
placebo tablet, twice a day for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

August 13, 2003

First Submitted That Met QC Criteria

August 13, 2003

First Posted (Estimate)

August 14, 2003

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on PG-116800 (given as PG-530742)

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