Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
Lead Sponsor:
Applied Therapeutics, Inc.
Conditions:
Diabetic Cardiomyopathies
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that A...
Eligibility Criteria
Inclusion
- Type 2 Diabetes Mellitus
- Diabetic cardiomyopathy
- Peak VO2 \< 75% of predicted normal value based on age and gender
Exclusion
- Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
- Prior echocardiogrphic measurement of ejection fraction (EF) \< 40%
- Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke
- Severe or moderate cardiac valve disease requiring intervention
- Clinically significant arrhythmia
- Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy
- Blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic) at screening
- HbA1c \>8.5% at screening
- Severe disease that would impact the performance of a cardio-pulmonary exercise test
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
675 Patients enrolled
Trial Details
Trial ID
NCT04083339
Start Date
September 20 2019
End Date
December 1 2025
Last Update
December 8 2022
Active Locations (79)
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1
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States, 90211
2
University of California, San Diego (UCSD)
La Jolla, California, United States, 92093
3
Clinical Trials Research
Lincoln, California, United States, 95648
4
University of California - Irvine Medical Center
Orange, California, United States, 92868