At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 711 enrolled
Drug / intervention
AZD4831 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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%
In Brief
A Phase 3 clinical trial evaluating AZD4831 and Placebo for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 711 participants across 171 sites in 18 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Hungary, Japan, Netherlands, Poland, Russia, Slovakia, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartJun 2021
First PostedAug 2021
Primary CompletionMar 2024
TodayJul 2026
First PostedAug 2, 2021
Enrollment StartJun 30, 2021
Primary CompletionMar 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.9 years ago
Interventions
AZD4831drug
AZD4831
Placeboother
Placebo