Eplerenone

Generic Name: Eplerenone

Brand Names: Inspra

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₀O_₆

CAS Number: 107724-20-9

Unique Ingredient Identifier: 6995V82D0B

Background: Eplerenone, an aldosterone receptor antagonist similar to spironolactone, has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion. The resulting increased plasma renin activity and aldosterone circulating levels do not overcome the effects of eplerenone. Eplerenone selectively binds to recombinant human mineralocorticoid receptors relative to its binding to recombinant human glucocorticoid, progesterone and androgen receptors.

Indication: For improvement of survival of stable patients with left ventricular systolic dysfunction (ejection fraction <40%) and clinical evidence of congestive heart failure after an acute myocardial infarction.

Associated Conditions: Hypertension, LVEF <40% Congestive heart failure, Chronic heart failure with reduced ejection fraction (NYHA Class II)

Associated Therapies: -

Clinical Trials

The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease

Phase 4

Terminated

Conditions: Transposition of the Great Vessels With an Arterial Switch
Single Ventricle With a Fontan Palliation
Tetralogy of Fallot

Interventions: Drug: Eplerenone

First Posted Date: 2013-10-29

Last Posted Date: 2018-05-04

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 26

Registration Number: NCT01971593

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

Phase IIb Safety and Efficacy Study 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 Moderate Chronic Kidney Disease Alone

Phase 2

Completed

Conditions: Heart Failure

Interventions: Drug: BAY94-8862
Drug: Eplerenone
Drug: Placebo

First Posted Date: 2013-10-07

Last Posted Date: 2021-07-16

Lead Sponsor: Bayer

Target Recruit Count: 72

Registration Number: NCT01955694

Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Phase 4

Conditions: Hypertensive Left Ventricular Hypertrophy

Interventions: Drug: Aliskiren
Drug: Eplerenone

First Posted Date: 2013-07-09

Last Posted Date: 2013-07-22

Lead Sponsor: Nagoya University

Target Recruit Count: 100

Registration Number: NCT01893788

Locations: 🇯🇵
Department of Cardiology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan

Aldosterone Antagonism and Microvascular Function

Phase 4

Terminated

Conditions: Abdominal Obesity Metabolic Syndrome
Insulin Resistance
Hypertension

Interventions: Drug: Eplerenone
Other: Placebo

First Posted Date: 2013-06-26

Last Posted Date: 2018-11-05

Lead Sponsor: Maastricht University Medical Center

Target Recruit Count: 25

Registration Number: NCT01887119

Locations: 🇳🇱
Maastricht University, Maastricht, Limburg, Netherlands

PHOspholamban RElated CArdiomyopathy STudy - Intervention

Phase 3

Completed

Conditions: Phospholamban R14del Mutation-related Cardiomyopathy

Interventions: Drug: Eplerenone

First Posted Date: 2013-05-20

Last Posted Date: 2021-10-18

Lead Sponsor: M.p. van den Berg, MD, PhD, professor in Cardiology

Target Recruit Count: 84

Registration Number: NCT01857856

Locations: 🇳🇱
Antonius ziekenhuis Sneek, Sneek, Friesland, Netherlands
🇳🇱
UMCG, Groningen, Netherlands
🇳🇱
UMCU, Utrecht, Netherlands

and more 1 locations

Eplerenone and Extracellular Adenosine Formation

Phase 4

Completed

Conditions: Pharmacodynamics

Interventions: Drug: Placebo
Drug: Eplerenone

First Posted Date: 2013-04-22

Last Posted Date: 2014-01-09

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 14

Registration Number: NCT01837108

Locations: 🇳🇱
Radboud University Medical Centre, Nijmegen, Gelderland, Netherlands

EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety

Phase 2

Conditions: Chronic Kidney Insufficiency
Kidney Transplantation

Interventions: Drug: Eplerenone

First Posted Date: 2013-04-18

Last Posted Date: 2013-04-18

Lead Sponsor: CHU de Reims

Target Recruit Count: 31

Registration Number: NCT01834768

Locations: 🇫🇷
Centre Hospitalier Universitaire de Reims, Reims, France

The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)

Not Applicable

Conditions: CKD II-III

Interventions: Drug: Eplerenone
Drug: Placebo

First Posted Date: 2013-04-16

Last Posted Date: 2020-06-19

Lead Sponsor: Medical University of Vienna

Target Recruit Count: 24

Registration Number: NCT01832558

Locations: 🇦🇹
Medical University of Vienna, Vienna, Austria

Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

Phase 2

Withdrawn

Conditions: Ascites
Cirrhosis

Interventions: Drug: Eplerenone

First Posted Date: 2013-02-28

Last Posted Date: 2016-01-15

Lead Sponsor: Emma Nilsson

Registration Number: NCT01801228

Locations: 🇸🇪
University Hospital of Skane, Lund, Skane, Sweden

Detection of Diffuse Scar in Patients With Diabetes

Phase 1

Conditions: Diabetes Mellitus, Type II

Interventions: Drug: Eplerenone
Drug: Placebo

First Posted Date: 2013-02-18

Last Posted Date: 2013-02-18

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 50

Registration Number: NCT01794091

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

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