- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
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, Polonia
- Klinika Kardiologii, Panstwowy Szpital Kliniczny
-
Bydgoszcz, Polonia
- Katedra i Klinika Kardiologii i Chorob Wewnetznych, Akademia Medyczna w Bydgoszczy
-
Katowice, Polonia
- 1 Katedra Kardiologii Slaskiej Akademii Medycznej
-
Krakow, Polonia
- Klinika Chorob Serca i Naczyn, Krakowski Szpital Specjalistyczny
-
Krakow, Polonia
- Oddzial Kardiologii, Wojewodzki Szpital Specjalistyczny
-
Lodz, Polonia
- Klinika Kardiologii IMW, Uniwersytet Medyczny w Lodzi
-
Poznan, Polonia
- I Klinika Kardilogii Akademii Medycznej w Poznaniu
-
Szczecin, Polonia
- Oddzial Internistyczno-Kardiologiczny, Samodzieiny Publiczny Wojewodzki Szpital Zespolony
-
Warszawa, Polonia
- I Klinika Choroby Wiencowej, Instytut Kardiologii w Warszawie
-
Warszawa, Polonia
- Klinika Choroby Wiencowej, Instytut Kardiologi w Warszawie
-
Warszawa, Polonia
- Klinika Kardilogii Inwazyjnej, Centrainy Szpital MSWiA
-
Warszawa, Polonia
- Klinika Kardiologii, Szpital Grochowski
-
-
-
-
Arkansas
-
Little Rock, Arkansas, Stati Uniti, 72205
- University of Arkansas for Medical Sciences and Central Arkansas Veterans Health Care System
-
-
California
-
Merced, California, Stati Uniti, 95340
- Mercy Community Medical Center
-
-
Colorado
-
Denver, Colorado, Stati Uniti, 80210
- Porter Adventist Hospital
-
-
Connecticut
-
Farmington, Connecticut, Stati Uniti, 06030-2202
- University of Connecticut Health Center
-
-
Florida
-
Atlantis, Florida, Stati Uniti, 33462
- JFK Medical Center
-
Clearwater, Florida, Stati Uniti, 33756
- Morton Plant Hospital
-
-
Georgia
-
Atlanta, Georgia, Stati Uniti, 30309
- Piedmont Hospital
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48202
- Henry Ford Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, Stati Uniti, 55407-1139
- Abbott-Northwestern Hospital
-
-
Missouri
-
St. Louis, Missouri, Stati Uniti, 63110
- Barnes Jewish Hospital
-
-
New York
-
Rochester, New York, Stati Uniti, 14642
- Strong Memorial Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28204
- Presbyterian Hospital
-
Greensboro, North Carolina, Stati Uniti, 27401
- Moses Cone Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stati Uniti, 73120
- Oklahoma Heart Hospital
-
-
Pennsylvania
-
Greensburg, Pennsylvania, Stati Uniti, 15601-2745
- Westmoreland Regional Hospital
-
Hershey, Pennsylvania, Stati Uniti, 17033-0850
- Hershey Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29403
- Medical University of South Carolina
-
-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37404-1127
- Memorial Hospital
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Memorial Hermann Hospital
-
-
West Virginia
-
Morgantown, West Virginia, Stati Uniti, 26506-9157
- West Virginia University Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
|
Comparatore placebo: Placebo tablet
Placebo tablet taken twice daily for 90 days
|
placebo tablet, twice a day for 90 days
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2002135
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su PG-116800 (given as PG-530742)
-
Procter and GambleCompletatoArtrosi, ginocchioUngheria, Regno Unito