Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate eplerenone across diverse conditions, including primary hypertension, left ventricular hypertrophy, paroxysmal atrial fibrillation, systemic proinflammatory states, and cardiotoxicity in breast cancer patients. Sponsored by academic medical centers such as Brigham and Women's Hospital and Assiut University alongside pharmaceutical companies like AstraZeneca and Bayer, these studies range from bioequivalence evaluations in healthy subjects to therapeutic efficacy trials in cardiac populations. Trial statuses encompass actively recruiting, completed, terminated, and upcoming investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07727252 NOT_YET_RECRUITING
Subclinical Primary Aldosteronism
Xinjiang Medical University
2026-08-01 PHASE2; PHASE3
NCT07238400 RECRUITING
Hypertension
Massachusetts General Hospital
2026-03-20 PHASE2
NCT03984591 ENROLLING_BY_INVITATION
Systolic Heart Failure
Bispebjerg Hospital
2020-11-01 PHASE4
NCT05797558 RECRUITING
Primary Hyperaldosteronism Due to Adrenal Adenoma
Göteborg University
2023-04-28
NCT07345845 ACTIVE_NOT_RECRUITING
Preeclampsia; Preeclampsia Postpartum
Anna Stanhewicz, PhD
2025-12-17 EARLY_PHASE1
NCT05593055 RECRUITING
Hypertension; Left Ventricular Hypertrophy
Brigham and Women's Hospital
2023-08-25 PHASE4
NCT07795762 NOT_YET_RECRUITING
Intraocular Pressure (IOP); Healthy Adult
University of Florida
2026-10-01 PHASE1
NCT07029503 RECRUITING
HFrEF - Heart Failure With Reduced Ejection Fraction; Chronic Kidney Disease
Karolinska Institutet
2026-02 PHASE2
NCT06749418 RECRUITING
Preeclampsia; Preeclampsia Postpartum
Anna Stanhewicz, PhD
2025-01-02 EARLY_PHASE1
NCT05030545 RECRUITING
Primary Aldosteronism; Hypertension
Brigham and Women's Hospital
2022-12-15 PHASE4
NCT06168994 NOT_YET_RECRUITING
Paroxysmal Atrial Fibrillation
Assiut University
2024-02-01 PHASE4
NCT05198791 RECRUITING
Myocardial Infarction, Acute; Myocardial Infarction With Nonobstructive Coronary Arteries; Myocardial Injury
NHS National Waiting Times Centre Board
2022-02-04 PHASE2
NCT06275763 UNKNOWN
Hypertension
National Institute of Cardiology, Warsaw, Poland
2023-10-20 PHASE4
NCT03418649 WITHDRAWN
Degenerative Intervertebral Discs; Sciatic Radiculopathy; Low Back Pain
University of Cincinnati
2023-06 PHASE4
NCT04450953 RECRUITING
Kidney Transplantation for More Than One Year; Patients with a Kidney Transplantation on Cyclosporine
Central Hospital, Nancy, France
2021-10-12 PHASE3
NCT04519164 COMPLETED
Metabolic Syndrome; Hypertension; Overweight and Obesity
Brigham and Women's Hospital
2020-12-01 PHASE4
NCT04840342 ACTIVE_NOT_RECRUITING
Hypertension; Mineralocorticoid Excess
Brigham and Women's Hospital
2022-02-03 PHASE4
NCT03476616 COMPLETED
Hypertension; Obesity
Hippocration General Hospital
2018-09-01 PHASE4
NCT06208072 UNKNOWN
Primary Hypertension; Obesity
Hippocration General Hospital
2023-09-01
NCT06556732 UNKNOWN
Atrial Fibrillation
Assiut University
2024-08-10 PHASE1
NCT06649409 COMPLETED
Pharmacodynamic
Santhera Pharmaceuticals
2024-06-05 PHASE1
NCT06168994 Not yet recruiting
Paroxysmal Atrial Fibrillation
Assiut University
2024-02-01 Phase 4
NCT06208072 Recruiting
Primary Hypertension|Obesity
Hippocration General Hospital|National and Kapodistrian University of Athens
2023-09-01 Not Applicable
NCT03683069 COMPLETED
Hypertension; Genetics Hypertension
Brigham and Women's Hospital
2019-01-15 PHASE4
NCT04746495 WITHDRAWN
Hypertension
University of Michigan
2023-02 PHASE4
NCT02740179 COMPLETED
HIV
Massachusetts General Hospital
2017-01
NCT04697485 WITHDRAWN
HF - Heart Failure; Diabetes Mellitus
Northwestern University
2021-01-08 PHASE4
NCT05663372 COMPLETED
Bioequivalence; Healthy Subjects
Darnitsa Pharmaceutical Company
2021-12-07 PHASE1
NCT02490904 ACTIVE_NOT_RECRUITING
End-stage Renal Disease
Central Hospital, Nancy, France
2016-10-19 PHASE3
NCT02525796 COMPLETED
Primary Hyperparathyroidism
Brigham and Women's Hospital
2016-01 PHASE2; PHASE3
NCT01857856 COMPLETED
Phospholamban R14del Mutation-related Cardiomyopathy
M.p. van den Berg, MD, PhD, professor in Cardiology
2013-05 PHASE3
NCT01996449 COMPLETED
Hypertension
University of Texas Southwestern Medical Center
2013-07 PHASE2
NCT04300881 TERMINATED
Vitreomacular Traction; Subretinal Edema
Wagner Macula & Retina Center
2019-10-04 PHASE2
NCT01832558 UNKNOWN
CKD II-III
Medical University of Vienna
2012-11
NCT03165240 COMPLETED
Diabetic Nephropathies
Boehringer Ingelheim
2017-10-05 PHASE1
NCT03923530 COMPLETED
Hypertension; Aortic Stenosis, Calcific; Quality of Life; Heart Failure With Preserved Ejection Fraction
North Florida Foundation for Research and Education
2019-06-03 EARLY_PHASE1
NCT03017703 COMPLETED
Endothelial Dysfunction; Insulin Resistance
University of Southern Denmark
2016-12-01
NCT02871648 COMPLETED
Healthy Volunteers
Brigham and Women's Hospital
2016-01 PHASE1
NCT03079141 UNKNOWN
Chronic Central Serous Chorioretinopathy
Leiden University Medical Center
2017-02-20 PHASE4
NCT02345590 UNKNOWN
Aortic Aneurysm, Abdominal
Bayside Health
2015-05 PHASE4
NCT01887119 TERMINATED
Abdominal Obesity Metabolic Syndrome; Insulin Resistance; Hypertension
Maastricht University Medical Center
2013-10 PHASE4
NCT02354352 COMPLETED
Duchenne Muscular Dystrophy
Ohio State University
2015-03-20 PHASE3
NCT02957435 WITHDRAWN
Pharmacokinetics; Healthy Subjects; Fasting
Biolab Sanus Farmaceutica
2017-07 PHASE1
NCT02809963 COMPLETED
Diabetes Type 2
Herlev Hospital
2015-11 PHASE4
NCT02629094 TERMINATED
Cardiac Steatosis; Hepatic Steatosis
National Institute of Allergy and Infectious Diseases (NIAID)
2015-12-02 PHASE2
NCT01794091 WITHDRAWN
Diabetes Mellitus, Type II
Brigham and Women's Hospital
2013-08 PHASE4
NCT02890173 COMPLETED
Essential Hypertension
Daiichi Sankyo Co., Ltd.
2016-09 PHASE3
NCT01405456 COMPLETED
HIV
Massachusetts General Hospital
2012-01
NCT01822561 COMPLETED
Central Serous Chorioretinopathy
Tufts Medical Center
2013-05 PHASE2
NCT02215330 UNKNOWN
Central Serous Chorioretinopathy
Prim. Prof. Dr. Oliver Findl, MBA
2014-10 PHASE2; PHASE3
NCT03186742 COMPLETED
Hypertension,Essential; Obstructive Sleep Apnea; Left Ventricular Hypertrophy
Poznan University of Medical Sciences
2014-07-01 PHASE4
NCT00223717 COMPLETED
Hypertension
Vanderbilt University
2001-01 PHASE1
NCT01708798 TERMINATED
Breast Cancer
University of British Columbia
2014-05 PHASE2; PHASE3
NCT02607657 WITHDRAWN
Healthy Volunteers
Biolab Sanus Farmaceutica
2016-05 PHASE1
NCT02462499 COMPLETED
Chronic Central Serous Chorioretinopathy
Semmelweis University
2014-06 PHASE4
NCT01394627 COMPLETED
Hypoglycemia
Brigham and Women's Hospital
2011-01
NCT01521546 COMPLETED
Duchenne Muscular Dystrophy
Subha Raman
2012-02
NCT01971593 TERMINATED
Tetralogy of Fallot; Transposition of the Great Vessels With an Arterial Switch; Single Ventricle With a Fontan Palliation
Washington University School of Medicine
2013-08 PHASE4
NCT01893788 UNKNOWN
Hypertensive Left Ventricular Hypertrophy
Nagoya University
2013-04 PHASE4
NCT02118753 COMPLETED
Ischemia-reperfusion Injury
Radboud University Medical Center
2014-03
NCT02532998 COMPLETED
Pharmacodynamics; Healthy Subjects
AstraZeneca
2015-09 PHASE1
NCT01801228 WITHDRAWN
Ascites; Cirrhosis
Emma Nilsson
2013-02 PHASE2
NCT01115855 COMPLETED
Heart Failure
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2010-07 PHASE3
NCT02345044 COMPLETED
Essential Hypertension
Daiichi Sankyo
2015-01 PHASE2
NCT02153125 UNKNOWN
Central Serous Chorioretinopathy
Tel-Aviv Sourasky Medical Center
2014-04 PHASE2
NCT01990677 COMPLETED
Central Serous Chorioretinopathy
Wills Eye
2013-10
NCT01586442 COMPLETED
Heart Failure; Type 2 Diabetes; Glucose Intolerance
Montreal Heart Institute
2012-03 PHASE3
NCT01955694 COMPLETED
Heart Failure
Bayer
2013-11-11 PHASE2
NCT01275352 WITHDRAWN
Hypertension
Washington University School of Medicine
2011-12 PHASE4
NCT01807221 COMPLETED
Heart Failure
Bayer
2013-06-17 PHASE2
NCT00825188 TERMINATED
Obesity; Hypertension
University of Mississippi Medical Center
2009-01
NCT01650012 COMPLETED
Hemodialysis; End Stage Renal Disease
McMaster University
2013-03
NCT01837108 COMPLETED
Pharmacodynamics
Radboud University Medical Center
2013-04 PHASE4
NCT00401856 COMPLETED
Cardiomyopathy
Royal Brompton & Harefield NHS Foundation Trust
2007-12 PHASE4
NCT01834768 UNKNOWN
Chronic Kidney Insufficiency; Kidney Transplantation
CHU de Reims
2013-02 PHASE2
NCT01427972 COMPLETED
Chronic Kidney Disease
Eli Lilly and Company
2011-09 PHASE2
NCT01786551 COMPLETED
Systemic Proinflammatory State
Brigham and Women's Hospital
2010-03
NCT01319344 COMPLETED
Metabolic Syndrome; Endothelial Dysfunction
University of Erlangen-Nürnberg Medical School
2010-09 PHASE3
NCT01176968 COMPLETED
Myocardial Infarction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2010-09 PHASE4
NCT01302236 WITHDRAWN
Hypertension; Chronic Kidney Disease.
Jichi Medical University
2011-03 PHASE4
NCT00647192 TERMINATED
Atrial Fibrillation
University Hospital, Saarland
2008-03 PHASE2
NCT01100203 TERMINATED
Chronic Kidney Disease
Lene Boesby
2010-04 PHASE3
NCT01373086 TERMINATED
Hypertension
Novartis Pharmaceuticals
2011-05 PHASE2
NCT00980031 TERMINATED
Myocardial Remodeling
Creighton University
2007-04
NCT00315016 COMPLETED
Diabetic Nephropathy
Radboud University Medical Center
2007-01 PHASE2
NCT01237899 COMPLETED
Chronic Kidney Disease
Eli Lilly and Company
2010-10 PHASE1
NCT00703352 COMPLETED
Transposition of Great Vessels; Atrial Switch Procedure
Hospital Universitari Vall d'Hebron Research Institute
2008-07 PHASE4
NCT01473108 COMPLETED
Clinical Pharmacology
Bayer
2010-03-29 PHASE1
NCT00232180 COMPLETED
Heart Failure
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2006-03 PHASE3
NCT00515021 COMPLETED
Metabolic Syndrome X
Vanderbilt University Medical Center
2007-04 PHASE4
NCT00990223 COMPLETED
Healthy Volunteers
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2009-10 PHASE1
NCT00817635 COMPLETED
Hypertension
Novartis
2008-12-22 PHASE2
NCT00430924 COMPLETED
Kidney Failure, Chronic
Lene Boesby
2007-03 PHASE4
NCT00758524 COMPLETED
Essential Hypertension
Novartis Pharmaceuticals
2008-09-11 PHASE2
NCT00608465 TERMINATED
Metabolic Syndrome X
Vanderbilt University
2006-05 PHASE4
NCT00187889 COMPLETED
Ischemic Heart Disease
University of Florida
2004-08 PHASE4
NCT00391846 COMPLETED
Heart Failure; Ventricular Dysfunction, Left
AstraZeneca
2006-10 PHASE4
NCT00505336 COMPLETED
Diastolic Heart Failure
St Vincent's University Hospital, Ireland
2006-04
NCT00138944 COMPLETED
Essential Hypertension
University of Erlangen-Nürnberg Medical School
2007-01 PHASE3
NCT00108251 COMPLETED
Congestive Heart Failure; Diastole
US Department of Veterans Affairs
2004-08 PHASE4
NCT00293150 TERMINATED
Diastolic Heart Failure
The Cleveland Clinic
2003-09 PHASE4
NCT00865618 COMPLETED
Hypertension
Sandoz
2006-06 PHASE1
NCT00865176 COMPLETED
Hypertension
Sandoz
2006-06 PHASE1
NCT00147563 COMPLETED
Hypertension
Pfizer
2003-10 PHASE4
NCT00214825 COMPLETED
Diabetes Mellitus; Endothelial Dysfunction; Albuminuria
Brigham and Women's Hospital
2003-08
NCT00147615 COMPLETED
Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2004-10 PHASE3
NCT00553722 UNKNOWN
Hypertension; Dialysis; Hyperaldosteronism
Shaare Zedek Medical Center
2007-11 PHASE4
NCT00132093 COMPLETED
Myocardial Infarction
NHS Greater Glasgow and Clyde
2005-04 PHASE4
NCT00082589 COMPLETED
Heart Failure, Congestive
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2004-04 PHASE4
NCT00147589 COMPLETED
Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
2004-09 PHASE3
NCT00649311 TERMINATED
Hypertension
Pfizer
2003-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-27)

Check the Eplerenone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eplerenone selectively binds to the mineralocorticoid receptor, competitively blocking the actions of aldosterone to prevent renal sodium retention and downstream cardiovascular inflammatory signaling. This target blockade reduces intravascular volume and pathological vascular remodeling, ultimately lowering systemic blood pressure and blunting adverse cardiac remodeling in clinical conditions such as hypertension and left ventricular hypertrophy.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.