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ACTIVE NOT RECRUITING
NCT04083339
PHASE3

Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

Sponsor: Applied Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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