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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: Active Phase 3 study of Diabetic Cardiomyopathies, sponsored by Applied Therapeutics.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Changes in Peak VO2 during cardio-pulmonary exercise test (CPET) from baseline to approximately Month 15 (15-18 months). A CPET may be repeated at approximately Month 27 (27-30 months).
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
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What the registry record for NCT04083339 still lists
NCT04083339 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT04083339's enrollment target sits among peer trials
675 538th of 2000 higher than 1,459 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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