- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00067236
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- Foothills Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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Edmonton, Alberta, Canada, T6L 5X8
- Grey Nuns Hospital
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Edmonton, Alberta, Canada, T5G 3C8
- Royal Alexandra Hospital
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British Columbia
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Campbell River, British Columbia, Canada, V9W 5Y4
- Alder Medical Centre
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Vancouver, British Columbia, Canada, V5Z 4E3
- Vancouver General Hospital
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Victoria, British Columbia, Canada, V8R 4R2
- Victoria Heart Institute
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New Brunswick
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St. John's, New Brunswick, Canada, A1B 3V6
- St. John's HSC
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 3H7
- Queen Elizabeth II HSC
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Ontario
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Newmarket, Ontario, Canada, L3Y 2R2
- Southlake Regional HC
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Scarborough, Ontario, Canada, M1S 4V5
- Scarborough Grace Hospital
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canada, M4C 3E7
- Toronto East General
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Quebec
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Fleurimont, Quebec, Canada, J1H 5N4
- CHUS, Hopital Fleurimont
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Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, Canada, H3A 1A1
- McGill University Health Centre, Royal Victoria Hospital
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Montreal, Quebec, Canada, H4J 1C5
- Hopital Sacre-Coeur
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Ste-Foy, Quebec, Canada, G1V 4G5
- Hôpital Laval
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
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California
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Merced, California, Forenede Stater, 95340
- Mercy Community Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80210
- Porter Adventist Hospital
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Connecticut
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Farmington, Connecticut, Forenede Stater, 06030-2202
- University of Connecticut Health Center
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Florida
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Atlantis, Florida, Forenede Stater, 33462
- JFK Medical Center
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Clearwater, Florida, Forenede Stater, 33756
- Morton Plant Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Hospital
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Hospital
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55407-1139
- Abbott-Northwestern Hospital
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Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- Barnes Jewish Hospital
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New York
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Rochester, New York, Forenede Stater, 14642
- Strong Memorial Hospital
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Presbyterian Hospital
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Greensboro, North Carolina, Forenede Stater, 27401
- Moses Cone Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73120
- Oklahoma Heart Hospital
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Pennsylvania
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Greensburg, Pennsylvania, Forenede Stater, 15601-2745
- Westmoreland Regional Hospital
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Hershey, Pennsylvania, Forenede Stater, 17033-0850
- Hershey Medical Center
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29403
- Medical University of South Carolina
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404-1127
- Memorial Hospital
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Texas
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Houston, Texas, Forenede Stater, 77030
- Memorial Hermann Hospital
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West Virginia
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Morgantown, West Virginia, Forenede Stater, 26506-9157
- West Virginia University Hospital
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Bialystok, Polen
- Klinika Kardiologii, Panstwowy Szpital Kliniczny
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Bydgoszcz, Polen
- Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
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Katowice, Polen
- 1 Katedra Kardiologii Slaskiej Akademii Medycznej
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Krakow, Polen
- Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
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Krakow, Polen
- Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
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Lodz, Polen
- Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
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Poznan, Polen
- I Klinika Kardilogii Akademii Medycznej w Poznaniu
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Szczecin, Polen
- Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
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Warszawa, Polen
- I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
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Warszawa, Polen
- Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
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Warszawa, Polen
- Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
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Warszawa, Polen
- Klinika Kardiologii, Szpital Grochowski
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
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Placebo komparator: Placebo tablet
Placebo tablet taken twice daily for 90 days
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placebo tablet, twice a day for 90 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2002135
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