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| NCT03418649 | WITHDRAWN | Degenerative Intervertebral Discs; Sciatic Radiculopathy; Low Back Pain |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)
Mechanism and Biochemical Profile
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>).