Study of Oral PG-116800 Following a Heart Attack
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
1 other identifier
interventional
253
3 countries
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2003
Shorter than P25 for phase_2
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2003
CompletedFirst Posted
Study publicly available on registry
August 14, 2003
CompletedStudy Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedResults Posted
Study results publicly available
November 4, 2011
CompletedNovember 4, 2011
September 1, 2011
1.3 years
August 13, 2003
August 3, 2011
September 27, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
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
Study Arms (2)
PG-116800 tablet
EXPERIMENTALPG-116800 tablet (200 mg) taken twice daily for 90 days
Placebo tablet
PLACEBO COMPARATORPlacebo tablet taken twice daily for 90 days
Interventions
200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
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
Royal Alexandra Hospital
Edmonton, Alberta, T5G 3C8, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Hospital
Edmonton, Alberta, T6L 5X8, 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
Saint 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 Village, Ontario, M1S 4V5, Canada
Toronto East General
Toronto, Ontario, M4C 3E7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
CHUS, Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Hopital Sacre-Coeur
Montreal, Quebec, H4J 1C5, Canada
Hopital Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Klinika Kardiologii, Panstwowy Szpital Kliniczny
Bialystok, Bialystok, Poland
Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
Bydgoszcz, Bydgoszcz, Poland
1 Katedra Kardiologii Slaskiej Akademii Medycznej
Katowice, Katowice, Poland
Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
Krakow, Krakow, Poland
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
Krakow, Krakow, Poland
I Klinika Kardilogii Akademii Medycznej w Poznaniu
Poznan, Poznan, Poland
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
Szczecin, Szczecin, Poland
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
Warsaw, Warszawa, Poland
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
Warsaw, Warszawa, Poland
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
Warsaw, Warszawa, Poland
Klinika Kardiologii, Szpital Grochowski
Warsaw, Warszawa, Poland
Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
Lodz, Łódź Voivodeship, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Thomas
- Organization
- Procter & Gamble
Study Officials
- STUDY DIRECTOR
Jose Brum, MD
Procter and Gamble
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2003
First Posted
August 14, 2003
Study Start
September 1, 2003
Primary Completion
December 1, 2004
Study Completion
December 1, 2004
Last Updated
November 4, 2011
Results First Posted
November 4, 2011
Record last verified: 2011-09