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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 8, 2022 (before its estimated December 2023 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 80 to 79
    v5
  2. Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Dec 2024 to Dec 2025
    • Eligibility criteria shortened, about 3 words
    v4
  3. Primary completion date: Sep 2021 to Dec 2022v3 Show 5 more changesShow less
    • Study sites: 4 to 80
    • Study completion date: Sep 2023 to Dec 2024
    • Eligibility criteria expanded, about 45 words
    • Secondary endpoints revised (3)
    • Primary endpoint revised
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Sep 2019 to Sep 20, 2019
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04083339
Lead Sponsor Applied Therapeutics, Inc.
Conditions
(from sponsor)		 Diabetic Cardiomyopathies
Related terms Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
Enrollment 675 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov