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NCT04083339 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Diabetic Cardiomyopathies, sponsored by Applied Therapeutics.

Active
Registry status
Phase 3
Development phase
675
Enrollment target
20
Study locations

NCT04083339 is a Phase 3 study of Diabetic Cardiomyopathies that is active but no longer recruiting, run by Applied Therapeutics. The registered enrollment target is 675 participants. The trial reports 20 study locations across 10 states.

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The verdict

NCT04083339, a Phase 3 study of Diabetic Cardiomyopathies, is active but no longer recruiting, sponsored by Applied Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
675 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AT-001

Study Locations (20)

California

  • Westside Medical Associates of Los Angeles - Beverly Hills
  • University of California, San Diego (UCSD) - La Jolla
  • Clinical Trials Research - Lincoln
  • University of California - Irvine Medical Center - Orange
  • Metabolic Institute of America - Tarzana
  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center - Torrance

Florida

  • ALL Medical Research, LLC - Cooper City
  • New Generation of Medical Research - Hialeah
  • Broward Research Center - Pembroke Pines
  • Progressive Medical Research - Port Orange

New York

  • Chear Center LLC - The Bronx
  • Montefiore Medical Center - The Bronx

Ohio

  • Cleveland Clinic - Cleveland
  • Remington Davis, Inc. - Columbus

Illinois

  • UnityPoint Health - Methodist Hospital - Peoria

Massachusetts

  • Brigham and Women's Hospital - Boston

Mississippi

  • Universty of Mississippi Medical Center - Jackson

Missouri

  • St. Louis Heart and Vascular Cardiology - St Louis

Trial Details

FieldValue
Enrollment Target 675 participants
Start Date 2019-09-20
Est. Completion 2025-12
Phase Phase 3

Sponsor

Applied Therapeutics

4 total trials

What the Registry Record Tells You About NCT04083339

The ClinicalTrials.gov registry entry for NCT04083339 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Applied Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Cardiomyopathies appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04083339 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04083339 about?

NCT04083339 is a clinical study titled "Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy". 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.

What is the current status of trial NCT04083339?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 675 participants. The study started on 2019-09-20. Estimated completion is 2025-12.

What conditions does trial NCT04083339 study?

This clinical trial studies the following conditions: Diabetic Cardiomyopathies.

What interventions are being tested in trial NCT04083339?

The interventions under investigation include: Placebo (DRUG), AT-001 (DRUG).

Who is sponsoring clinical trial NCT04083339?

This trial is sponsored by Applied Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04083339 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.