Back to resultsStudy of Oral PG-116800 Following a Heart Attack
Primary Purpose
Myocardial Infarction, Heart Failure, Heart Enlargement
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PG-116800 (given as PG-530742)
Placebo tablet
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility 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.
Sites / Locations
- University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
- Mercy Community Medical Center
- Porter Adventist Hospital
- University of Connecticut Health Center
- JFK Medical Center
- Morton Plant Hospital
- Piedmont Hospital
- Henry Ford Hospital
- Abbott-Northwestern Hospital
- Barnes Jewish Hospital
- Strong Memorial Hospital
- Presbyterian Hospital
- Moses Cone Hospital
- Oklahoma Heart Hospital
- Westmoreland Regional Hospital
- Hershey Medical Center
- Rhode Island Hospital
- Medical University of South Carolina
- Memorial Hospital
- Memorial Hermann Hospital
- West Virginia University Hospital
- Foothills Hospital
- Royal Alexandra Hospital
- University of Alberta Hospital
- Grey Nuns Hospital
- Alder Medical Centre
- Vancouver General Hospital
- Victoria Heart Institute
- St. John's HSC
- Queen Elizabeth II HSC
- Southlake Regional HC
- Scarborough Grace Hospital
- Toronto East General
- St. Michael's Hospital
- CHUS, Hopital Fleurimont
- Montreal Heart Institute
- McGill University Health Centre, Royal Victoria Hospital
- Montreal General Hospital
- Hopital Sacre-Coeur
- Hopital Laval
- Klinika Kardiologii, Panstwowy Szpital Kliniczny
- Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
- 1 Katedra Kardiologii Slaskiej Akademii Medycznej
- Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
- Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
- Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
- I Klinika Kardilogii Akademii Medycznej w Poznaniu
- Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
- I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
- Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
- Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
- Klinika Kardiologii, Szpital Grochowski
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PG-116800 tablet
Placebo tablet
Arm Description
PG-116800 tablet (200 mg) taken twice daily for 90 days
Placebo tablet taken twice daily for 90 days
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00067236
Brief Title
Study of Oral PG-116800 Following a Heart Attack
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral PG-116800 Following a Heart Attack
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Heart Failure, Heart Enlargement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PG-116800 tablet
Arm Type
Experimental
Arm Description
PG-116800 tablet (200 mg) taken twice daily for 90 days
Arm Title
Placebo tablet
Arm Type
Placebo Comparator
Arm Description
Placebo tablet taken twice daily for 90 days
Intervention Type
Drug
Intervention Name(s)
PG-116800 (given as PG-530742)
Intervention Description
200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days
Intervention Type
Drug
Intervention Name(s)
Placebo tablet
Intervention Description
placebo tablet, twice a day for 90 days
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
Description
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)
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Brum, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mercy Community Medical Center
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-2202
Country
United States
Facility Name
JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407-1139
Country
United States
Facility Name
Barnes Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Moses Cone Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Westmoreland Regional Hospital
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601-2745
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404-1127
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9157
Country
United States
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 3C8
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Grey Nuns Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Alder Medical Centre
City
Campbell River
State/Province
British Columbia
ZIP/Postal Code
V9W 5Y4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E3
Country
Canada
Facility Name
Victoria Heart Institute
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
St. John's HSC
City
St. John's
State/Province
New Brunswick
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Queen Elizabeth II HSC
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3H7
Country
Canada
Facility Name
Southlake Regional HC
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2R2
Country
Canada
Facility Name
Scarborough Grace Hospital
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S 4V5
Country
Canada
Facility Name
Toronto East General
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
CHUS, Hopital Fleurimont
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
McGill University Health Centre, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hopital Sacre-Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Klinika Kardiologii, Panstwowy Szpital Kliniczny
City
Bialystok
Country
Poland
Facility Name
Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
City
Bydgoszcz
Country
Poland
Facility Name
1 Katedra Kardiologii Slaskiej Akademii Medycznej
City
Katowice
Country
Poland
Facility Name
Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
City
Krakow
Country
Poland
Facility Name
Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
City
Krakow
Country
Poland
Facility Name
Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
City
Lodz
Country
Poland
Facility Name
I Klinika Kardilogii Akademii Medycznej w Poznaniu
City
Poznan
Country
Poland
Facility Name
Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
City
Szczecin
Country
Poland
Facility Name
I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
City
Warszawa
Country
Poland
Facility Name
Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
City
Warszawa
Country
Poland
Facility Name
Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
City
Warszawa
Country
Poland
Facility Name
Klinika Kardiologii, Szpital Grochowski
City
Warszawa
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Study of Oral PG-116800 Following a Heart Attack
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