Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Bayer
Study ID
NCT01807221
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 17, 2013
Status verified
Jul 2021
Primary completion
Nov 11, 2014
Completion
Dec 9, 2014

Study Design

Enrollment
1,066 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone(BAY94-8862)[2.5mg] + Placebo
    Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
  • Experimental: Finerenone (BAY94-8862)[5mg] + Placebo
    Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
  • Experimental: Finerenone (BAY94-8862)[7.5mg] + Placebo
    Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
  • Experimental: Finerenone (BAY94-8862)[10mg] + Placebo
    Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
  • Experimental: Finerenone (BAY94-8862)[15mg] + Placebo
    Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
  • Active Comparator: Eplerenone [25 mg] + Placebo
    Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.

Primary Outcome Measure

Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 [ Time Frame: Baseline and Day 90 ]

Locations (10)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35294-2041-
-La JollaCalifornia92037-
-Los AngelesCalifornia90033-
-JacksonvilleFlorida32209-
-MaconGeorgia31201-
-BaltimoreMaryland21201-
-DetroitMichigan48201-
-DetroitMichigan48202-
-NewarkNew Jersey07103-
-FairfieldOhio45014-

Find similar trials in Birmingham, AL

By condition
Heart failure
By specialty
CardiologyHeart disease

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