CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,263 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom 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.

Search/NCT03619213
NCT03619213Phase 3Completed

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

AstraZeneca·interventional·Posted Aug 7, 2018·Updated Jul 11, 2023

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Placebo for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 6,263 participants across 348 sites in 20 countries.

Detailed Summary

This is an international, multicentre, parallel-group, event-driven, randomised, double-blind, placebo-controlled study in HFpEF patients, evaluating the effect of dapagliflozin 10 mg versus placebo, given once daily in addition to background regional standard of care therapy, including treatments to control co-morbidities, in reducing the composite of CV death or heart failure events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Hungary, Japan, Mexico, Netherlands, Peru, Poland, Romania, Russia, Saudi Arabia, Spain, Taiwan, United States, Vietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 7, 2018
Enrollment StartAug 27, 2018
Primary CompletionMar 27, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.9 years ago

Interventions

Dapagliflozindrug

10 mg tablets given once daily, per oral use.

Placebodrug

Placebo matching dapagliflozin 10 mg