CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 enrolled
Drug / intervention
Empagliflozin +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.

Search/NCT03448419
NCT03448419Phase 3Completed

A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Reduced Ejection Fraction (HFrEF) (EMPERIAL-reduced)

Boehringer Ingelheim·interventional·Posted Feb 28, 2018·Updated Nov 27, 2020

In Brief

A Phase 3 clinical trial evaluating Empagliflozin and Placebo for Heart Failure. Completed, enrolled 312 participants across 109 sites in 11 countries.

Detailed Summary

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test in patients with chronic HF with reduced ejection fraction (LVEF ≤ 40%) Secondary objectives are to assess Patient-Reported Outcome (PRO)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustralia, Canada, Germany, Greece, Italy, Norway, Poland, Portugal, Spain, Sweden, United States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 28, 2018
Enrollment StartMar 20, 2018
Primary CompletionSep 30, 2019
Study CompletionOct 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.3 years ago

Interventions

Empagliflozindrug

Film-coated tablet

Placebodrug

Film-coated tablet