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Eplerenone

Phase 3

Heart Failure | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Dec 22, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment2,964

FDA Designations

No designations recorded

Clinical trial landscape

Eplerenone · 4 trials · 2 indications

Phase 3 4
NCT01115855Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart FailureHeart Failure
COMPLETED221 Analytics
NCT00232180A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure MedicinesHeart Failure
COMPLETED2,743 Analytics
NCT00147615The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 YearsHypertension
COMPLETED140 Analytics
NCT00147589A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.Hypertension
COMPLETED320 Analytics
PHASE3COMPLETED
Clinical Study Of Eplerenone In Japanese Patients With Chronic Heart Failure
Heart FailureUnlock trial analytics
PHASE3COMPLETED
A Comparison Of Outcomes In Patients In New York Heart Association (NYHA) Class II Heart Failure When Treated With Eplerenone Or Placebo In Addition To Standard Heart Failure Medicines
Heart FailureUnlock trial analytics
PHASE3COMPLETED
The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years
HypertensionUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF)
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)

CV mortality was defined as any death due to HF, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident, other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF was defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF. Hazard ratio of Eplerenone versus placebo for first occurrence of the event was obtained from a Cox proportional hazards model.

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date
Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated)
Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011)

CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator.

Safety of eplerenone in hypertensive children
Efficacy of eplerenone in children

Secondary Endpoints

Number of Participants With First Occurrence of Cardiovascular (CV) Mortality, Hospitalization Due to Heart Failure (HF), or Addition/Increase of Heart Failure (HF) Medication
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Number of Participants With With First Occurrence of All-Cause Mortality
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
Number of Participants With With First Occurrence of Cardiovascular Mortality
Randomization up to the date when the last enrolled participant had been followed up for 1 year (up to 1744 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Eplerenone armEXPERIMENTALAdd on standard heart failure therapy
Placebo armPLACEBO_COMPARATORAdd on standard heart failure therapy

Interventions

NameTypeDescription
EplerenoneDRUGEplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
PlaceboDRUGPlacebo once daily or every once daily
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * Japanese chronic systolic heart failure patients with LVEF =\<30% by echocardiography and NYHA II or more * Patients who receive standard therapy (Angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blocker or diuretic) Exclusion Criteria: * Patient...

Countries:JapanUnited StatesArgentinaAustraliaBelgiumCanadaCzechiaFranceGermanyGreeceHong KongHungaryIndiaIrelandItalyMexicoNetherlandsPolandPortugalRussiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenUkraineUnited Arab EmiratesUnited KingdomVenezuelaDominican Republic
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Frequently asked questions about Eplerenone

What is Eplerenone used for?

Eplerenone is a small molecule used for hypertension and heart failure. It is being developed by Pfizer, Inc. for these cardiovascular conditions. The drug is currently in Phase 3 clinical development, meaning it is investigational and not yet approved for these uses.

How does Eplerenone work?

Eplerenone is a small molecule that targets the mineralocorticoid receptor, blocking aldosterone's effects. This action helps treat hypertension and heart failure by reducing sodium retention and fluid buildup, which lowers blood pressure and decreases strain on the heart.

Who makes Eplerenone?

Eplerenone is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker PFE. Pfizer is conducting Phase 3 clinical trials for this drug in hypertension and heart failure.

What phase is Eplerenone in?

Eplerenone is in Phase 3 clinical development. It is an investigational drug for hypertension and heart failure, meaning it has not yet received FDA approval. All four Phase 3 trials for Eplerenone have been completed.

What clinical trials is Eplerenone in?

Eplerenone has completed four Phase 3 trials. NCT00147589 and NCT00147615 studied hypertension in children aged 6 to 16 years. NCT00232180 and NCT01115855 studied heart failure in adults aged 55 years and older. All trials are completed.

Is Eplerenone the same as Inspra?

Eplerenone is the generic name for the drug marketed as Inspra. The clinical trials listed under Eplerenone, such as NCT00232180 for heart failure, refer to this same compound. Pfizer develops Eplerenone under this generic name.