CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,066 enrolled
Drug / intervention
Finerenone (BAY94-8862) +2 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/NCT01807221
NCT01807221Phase 2Completed

A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

Bayer·interventional·Posted Mar 8, 2013·Updated Jul 6, 2021

In Brief

A Phase 2 clinical trial evaluating Finerenone (BAY94-8862), Placebo, and 1 other intervention for Heart Failure. Completed, enrolled 1,066 participants across 172 sites in 25 countries.

Detailed Summary

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesAustralia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 8, 2013
Enrollment StartJun 17, 2013
Primary CompletionNov 11, 2014
Study CompletionDec 9, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.3 years ago

Interventions

Finerenone (BAY94-8862)drug

Placebodrug

Inspra (eplerenone)drug