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Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Sponsor: Applied Therapeutics, Inc.
Summary
This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.
Official title: Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
675
Start Date
2019-09-20
Completion Date
2025-12
Last Updated
2022-12-08
Healthy Volunteers
No
Conditions
Interventions
AT-001
AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner. At present AT001 is the sole name for the active substance. No INN/genetic name is available to date
Placebo
Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner
Locations (79)
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
University of California, San Diego (UCSD)
La Jolla, California, United States
Clinical Trials Research
Lincoln, California, United States
University of California - Irvine Medical Center
Orange, California, United States
Metabolic Institute of America
Tarzana, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
New Generation of Medical Research
Hialeah, Florida, United States
Broward Research Center
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
UnityPoint Health - Methodist Hospital
Peoria, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Universty of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, United States
Chear Center LLC
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Remington Davis, Inc.
Columbus, Ohio, United States
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States
Mountain View Clinical Research - Greer
Greer, South Carolina, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Juno Research, LLC - Northwest Site
Houston, Texas, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, United States
FMC Science
Lampasas, Texas, United States
Prince Charles Hospital
Chermside, Queensland, Australia
CORE Research Group Pty. Ltd.
Milton, Queensland, Australia
AusTrials
Taringa, Queensland, Australia
University of Tasmania at Hobart
Hobart, Tasmania, Australia
Barwon Health-University Hospital Geelong
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
C-Endo - Endocrinology Centre
Calgary, Alberta, Canada
BC Diabetes
Vancouver, British Columbia, Canada
LMC Diabetes & Endocrinology Ltd. - Brampton
Brampton, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Thornhill
Concord, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Etobicoke
Etobicoke, Ontario, Canada
Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University
London, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Toronto
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, Canada
Edumed s.r.o.
Jaroměř, Czechia
Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice
Pardubice, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition
Bondy, France
CHU Henri Mondor
Créteil, France
CHU de Nantes, Clinique d'Endocrinologie
Nantes, France
Centre Hospitalier de Valenciennes
Valenciennes, France
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Brandenburg, Germany
Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum
Bad Oeynhausen, North Rhine-Westphalia, Germany
Cardiologicum Pirna und Dresden
Dresden, Saxony, Germany
Klinische Forschung Berlin GbR
Berlin, Germany
ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH
Elsterwerda, Germany
Erik Yee Mun George Fung
Shatin, Hong Kong
Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics
Shatin, Hong Kong
Centrum Chorob Serca w USK
Wroclaw, Borowska, Poland
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, Poland
Topolowa MEDICENTER Mrózek & wspólnicy sp.j.
Krakow, Poland
Centrum Twojego Zdrowia
Krakow, Poland
ETG Lodz
Lodz, Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, Poland
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika
Radom, Poland
Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK
Rzeszów, Poland
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, Poland
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Abente y Lago (Complejo Universitario de la Coruña)
A Coruña, Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Ninewells Hospital & Medical School
Dundee, United Kingdom
CPS Research
Glasgow, United Kingdom
Glenfield hospital
Leicester, United Kingdom
Barts and The London School of Medicine & Dentistry
London, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom