Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
NCT04986202 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 711
Last updated 2025-08-27
Summary
This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction \> 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 820 in Part B.
Conditions
Interventions
- DRUG
-
AZD4831
AZD4831
- OTHER
-
Placebo
Placebo
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2024-03-27
- Completion
- 2024-03-27
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Brazil
- Bulgaria
- Canada
- Czechia
- Denmark
- France
- Hungary
- Japan
- Netherlands
- Poland
- Russia
- Slovakia
- Sweden
- Taiwan
- Turkey (Türkiye)
Study Locations
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