Clinical Trials

Spironolactone has been evaluated in numerous clinical trials spanning early through late phases for indications such as heart failure, hypertension, acute myocardial infarction, alcohol use disorder, and polycystic ovary syndrome. Sponsored by academic centers, hospital networks, government health organizations, and commercial developers, these trials reflect recruitment statuses ranging from completed to actively recruiting or not yet recruiting. Completed late-phase clinical trials have evaluated post-myocardial infarction cardiovascular outcomes, whereas early-phase studies continue to explore novel therapeutic applications.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07020104 RECRUITING
Chronic Kidney Diseases
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2025-01-07
NCT07645300 NOT_YET_RECRUITING
Hypertension Treated With Antihypertensive Drugs; Chronic Kidney Disease, 3B and 4
VA Office of Research and Development
2026-10-01 PHASE2
NCT07539259 NOT_YET_RECRUITING
Aortic Stenosis
University College, London
2026-12 PHASE2
NCT03984591 ENROLLING_BY_INVITATION
Systolic Heart Failure
Bispebjerg Hospital
2020-11-01 PHASE4
NCT07483177 RECRUITING
Thoracic Aortic Aneurysm
Mayo Clinic
2026-05-25 PHASE1; PHASE2
NCT07585526 NOT_YET_RECRUITING
MASLD; Chronic Kidney Diseases
Institute of Liver and Biliary Sciences, India
2026-04-15
NCT07304817 RECRUITING
CKD; Cardiovascular Diseases; Heart Failure
University Medical Center Groningen
2026-05-12 PHASE2
NCT07687160 NOT_YET_RECRUITING
Hypertension
Ottawa Hospital Research Institute
2026-09-01 PHASE4
NCT06204640 NOT_YET_RECRUITING
Atrial Fibrillation Recurrent
University Hospital, Caen
2024-03-01 PHASE3
NCT07041281 RECRUITING
Preeclampsia; Gestational Hypertension
Massachusetts General Hospital
2025-10-16 PHASE2
NCT07715318 NOT_YET_RECRUITING
Anemia
Ain Shams University
2026-12-01 PHASE2
NCT03593317 RECRUITING
Arrhythmogenic Right Ventricular Dysplasia
Hospices Civils de Lyon
2024-12-20 PHASE2
NCT07281014 ACTIVE_NOT_RECRUITING
Heart Failure
Yale University
2026-01-27 PHASE4
NCT07431216 NOT_YET_RECRUITING
Glioblastoma (GBM)
Starlight Therapeutics Inc.
2026-05-01 PHASE1; PHASE2
NCT07688928 RECRUITING
Primary Aldosteronism; Endocrine Hypertension
Bangladesh Medical University
2026-04-15
NCT01712620 RECRUITING
Pulmonary Arterial Hypertension
National Institutes of Health Clinical Center (CC)
2014-01-10 PHASE2
NCT05807139 RECRUITING
Alcohol Use Disorder
National Institute on Drug Abuse (NIDA)
2023-07-13 PHASE1
NCT06678685 RECRUITING
NCOR Gene Mutations; Spironolactone; ASD
Qilu Hospital of Shandong University
2024-10-30 PHASE2; PHASE3
NCT02901184 RECRUITING
Heart Failure With Preserved Ejection Fraction
Uppsala University
2017-11-23 PHASE3
NCT07523867 NOT_YET_RECRUITING
Heart Failure; Diabetic Kidney Disease; Hyperkalemia
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
2026-04 PHASE4
NCT07473895 NOT_YET_RECRUITING
Acne Vulgaris
Assiut University
2026-04 PHASE2
NCT07223502 RECRUITING
Hypertension (HTN)
Sarfez Pharmaceuticals, Inc.
2025-12-01 PHASE3
NCT04901975 COMPLETED
Single-ventricle
Children's Hospital of Philadelphia
2021-02-11 PHASE1; PHASE2
NCT06035978 UNKNOWN
Cardiovascular Diseases; Heart Failure With Reduced Ejection Fraction
University Hospital Ostrava
2024-03 PHASE4
NCT05092984 RECRUITING
Rheumatoid Arthritis
University Hospital, Strasbourg, France
2022-06-22 PHASE3
NCT07046975 COMPLETED
Bioavailability Heathy Volunteers
Sarfez Pharmaceuticals, Inc.
2025-06-15 PHASE3
NCT04582383 ACTIVE_NOT_RECRUITING
Acne
University of Pennsylvania
2022-03-30 PHASE4
NCT04760717 ACTIVE_NOT_RECRUITING
Intracerebral Hemorrhage; Ischemic Stroke; Spironolactone
Yale University
2021-03-19 PHASE2
NCT06004830 COMPLETED
Alcohol Use Disorder; Hiv
Yale University
2023-11-06 PHASE2
NCT07328230 RECRUITING
Idiopathic Hyperaldosteronism; Hyperaldosteronism
Chinese Academy of Medical Sciences, Fuwai Hospital
2022-08-01
NCT05754684 RECRUITING
Neuroblastoma Recurrent
Hong Kong Children's Hospital
2022-01-01 PHASE2
NCT06523465 RECRUITING
Primary Aldosteronism; Statin; Mineralocorticoid Receptor Antagonist; Hypertension
Third Military Medical University
2024-09-10 PHASE4
NCT07043634 COMPLETED
Bioavailability Heathy Volunteers
Sarfez Pharmaceuticals, Inc.
2025-06-15 PHASE3
NCT07015671 COMPLETED
Bioequivalence Study in Healthy Subjects; PK/PD
Sarfez Pharmaceuticals, Inc.
2025-07-01 PHASE3
NCT06275763 UNKNOWN
Hypertension
National Institute of Cardiology, Warsaw, Poland
2023-10-20 PHASE4
NCT03429946 COMPLETED
Hypoglycemia; Healthy
Brigham and Women's Hospital
2013-07-17 PHASE4
NCT06499948 COMPLETED
Alport Syndrome; Thin Basement Membrane Disease; Alport Nephropathy
Stefan Lujinschi
2024-02-26 PHASE4
NCT06005259 UNKNOWN
Cardiotoxicity; Neoplasms; Chemotherapy Effect; Heart Failure
University of Sao Paulo
2023-10-01 PHASE4
NCT04723862 RECRUITING
Hyperandrogenism; Polycystic Ovary Syndrome; Puberty
University of Virginia
2021-11-12 EARLY_PHASE1
NCT03068910 RECRUITING
Hyperandrogenism; Polycystic Ovary Syndrome; Puberty
University of Virginia
2016-07-21 EARLY_PHASE1
NCT04522739 COMPLETED
Mild Cognitive Impairment; Alzheimer Disease
Emory University
2022-09-06 PHASE4
NCT05501080 RECRUITING
Primary Aldosteronism
Second Affiliated Hospital of Nanchang University
2022-09-01
NCT03929718 ACTIVE_NOT_RECRUITING
AFib
Piedmont Healthcare
2019-04-24 EARLY_PHASE1
NCT06457074 UNKNOWN
Primary Aldosteronism
Qifu Li
2024-06-04 PHASE4
NCT05230901 UNKNOWN
Aortic Stenosis, Severe
University Medical Center Goettingen
2022-02-23 PHASE3
NCT05394142 UNKNOWN
Polycystic Ovary Syndrome (PCOS)
Fundació Sant Joan de Déu
2022-05-24 PHASE2
NCT03020303 COMPLETED
Endstage Renal Disease
Hamilton Health Sciences Corporation
2017-07-07 PHASE3
NCT05814770 UNKNOWN
Primary Aldosteronism; Hypertension
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2023-05 PHASE4
NCT06021860 UNKNOWN
Edema Due to Heart Failure or Cirrhosis
CMP Development, LLC
2024-06 PHASE4
NCT04409431 UNKNOWN
Primary Aldosteronism; Hypertension
Third Military Medical University
2019-12-01
NCT06164379 UNKNOWN
Primary Aldosteronism
Shanghai Jiao Tong University School of Medicine
2023-12-16 PHASE4
NCT07415811 ENROLLING_BY_INVITATION
HIV
University of Sao Paulo General Hospital
2024-07-24
NCT01422759 UNKNOWN
Obesity; Hyperandrogenemia; Polycystic Ovary Syndrome
University of Virginia
2016-12-09
NCT05676684 COMPLETED
Heart Failure With Preserved Ejection Fraction
Universidade do Porto
2022-09-15 PHASE2; PHASE3
NCT04727073 TERMINATED
Heart Failure with Mid-range Ejection Fraction; Heart Failure with Preserved Ejection Fraction
Charite University, Berlin, Germany
2018-11-01 PHASE3
NCT04075149 UNKNOWN
Polycystic Ovary Syndrome; Puberty Disorders; Ovulation Disorder
University of Virginia
2019-12-18 EARLY_PHASE1
NCT03048825 COMPLETED
ST Elevation Myocardial Infarction; Non ST Elevation Myocardial Infarction
Population Health Research Institute
2018-02-01 PHASE3
NCT04676646 COMPLETED
Hyperkalaemia; Heart Failure With Reduced Ejection Fraction
AstraZeneca
2021-03-08 PHASE4
NCT06021860 Not yet recruiting
Edema Due to Heart Failure or Cirrhosis
CMP Development LLC
2024-06 Phase 4
NCT04331691 COMPLETED
Resistant Hypertension
Yonsei University
2020-11-16 PHASE4
NCT05849766 COMPLETED
Dilated Cardiomyopathy
October 6 University
2023-04-27 PHASE3
NCT06205407 COMPLETED
Healthy Participants
Pfizer
2023-12-26 PHASE1
NCT06204640 Not yet recruiting
Atrial Fibrillation Recurrent
University Hospital Caen
2024-03-01 Phase 3
NCT05995392 UNKNOWN
Dry Eye Disease
Richard W Yee, MD
2023-08 EARLY_PHASE1
NCT04455178 UNKNOWN
Hypertension
Shanghai Jiao Tong University School of Medicine
2020-09-23 PHASE4
NCT05222191 UNKNOWN
Renal Insufficiency; Chronic Hypertension
Indiana Institute for Medical Research
2022-02-01 PHASE2
NCT03867682 UNKNOWN
Acute Myeloid Leukemia; Relapsed Adult AML
Actinium Pharmaceuticals
2020-01-15 PHASE1; PHASE2
NCT05010707 COMPLETED
Transgenderism
Washington University School of Medicine
2021-08-02 PHASE2
NCT06413082 COMPLETED
Hypertension; Genetic Predisposition; Drug Effect
Ospedale San Raffaele
2021-02-15 PHASE3
NCT03576755 COMPLETED
NASH - Nonalcoholic Steatohepatitis
University of California, San Francisco
2019-01-09 PHASE1; PHASE2
NCT05807139 Recruiting
Alcohol Use Disorder
National Institute on Drug Abuse (NIDA)|National Institutes of Health Clinical Center (CC)
2023-07-13 Phase 1
NCT06579053 COMPLETED
Bioequivalence Study
SPH Sine Pharmaceutical Laboratories Co., Ltd.
2023-03-22 PHASE1
NCT04190433 WITHDRAWN
Breast Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Lymphoma; Sarcoma
Mayo Clinic
2020-09-01 PHASE2
NCT04205136 WITHDRAWN
Obstructive Sleep Apnea
University of Michigan
2022-03 PHASE4
NCT03334682 COMPLETED
Acne Vulgaris
Nantes University Hospital
2018-01-31 PHASE3
NCT01848639 COMPLETED
End Stage Renal Failure on Dialysis
University Hospital, Brest
2013-06 PHASE3
NCT04283656 COMPLETED
Transgender Health; Gender Dysphoria; Transgender Women; Human Immunodeficiency Virus
Thomas Jefferson University
2022-01-04 PHASE1
NCT03502031 UNKNOWN
Renal Insufficiency, Chronic; Diabetic Nephropathy Type 2
James A. Tumlin, MD
2018-10-01 PHASE4
NCT04853355 WITHDRAWN
Diabetic Maculopathy
Wake Forest University Health Sciences
2022-07 PHASE4
NCT03344159 COMPLETED
Chronic Right-Sided Heart Failure; Pulmonary Arterial Hypertension; Pulmonary Hypertension, Primary, 2; Pulmonary Hypertension, Primary, 3; Pulmonary Hypertension, Primary, 4; Cardiomyopathy Right Ventricular
Ottawa Heart Institute Research Corporation
2018-04-01 PHASE4
NCT04465123 UNKNOWN
Acute Heart Failure; Acute Kidney Injury
Chiang Mai University
2020-08-13 PHASE3
NCT05092984 Recruiting
Rheumatoid Arthritis
University Hospital Strasbourg France
2022-06-22 Phase 3
NCT04327232 UNKNOWN
Atrial Fibrillation
National University Hospital, Singapore
2018-05-23 PHASE2
NCT02169089 COMPLETED
Atherosclerosis
University Hospitals Cleveland Medical Center
2016-01 PHASE4
NCT04618601 UNKNOWN
Heart Failure Acute; Heart Failure; With Decompensation
Laikο General Hospital, Athens
2020-10-20 PHASE4
NCT04367051 COMPLETED
Heart Failure
Asan Medical Center
2020-08-13
NCT04643691 TERMINATED
COVID-19; ARDS
Assistance Publique Hopitaux De Marseille
2020-09-11 PHASE2
NCT04723862 Recruiting
Hyperandrogenism|Polycystic Ovary Syndrome|Puberty
University of Virginia|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
2021-11-12 Early Phase 1
NCT03777319 TERMINATED
Muscular Dystrophy, Duchenne
Kevin Flanigan
2018-12-05 PHASE1
NCT04912011 UNKNOWN
COVID-19 Pneumonia
Pomeranian Medical University Szczecin
2021-01-01 PHASE4
NCT04826822 UNKNOWN
Coronavirus Infection; Pneumonia, Viral
Chita State Regional Clinical Hospital Number 1
2021-02-24 PHASE3
NCT03551548 UNKNOWN
Cardiac Surgery; Atrial Fibrillation; Aldosterone Blockade
University Hospital, Caen
2019-02-26 PHASE3
NCT02497300 COMPLETED
Chronic Kidney Disease; Albuminuria
University of Alabama at Birmingham
2015-03 PHASE2
NCT04100083 WITHDRAWN
Hidradenitis Suppurativa
Medical University of South Carolina
2020-09-21 PHASE4
NCT01602861 COMPLETED
Disorder Related to Renal Transplantation
Odense University Hospital
2013-02 PHASE4
NCT03953209 WITHDRAWN
Melasma
Medical University of South Carolina
2020-03-05 PHASE1
NCT02230891 COMPLETED
Hypertension; Diabetes; Cardiovascular Disease
VA Office of Research and Development
2014-10-01 PHASE2
NCT03953950 UNKNOWN
End Stage Renal Disease; Peritoneal Dialysis
Chiang Mai University
2019-10 PHASE4
NCT03626506 UNKNOWN
Hypertension
Peking University Third Hospital
2019-02-13
NCT03597035 TERMINATED
Type2 Diabetes; Hyperkalemia
University Hospitals Cleveland Medical Center
2018-07-17 PHASE4
NCT04424134 UNKNOWN
COVID 19
Lomonosov Moscow State University Medical Research and Educational Center
2020-05-16 PHASE3
NCT04393493 COMPLETED
Cardiorenal Syndrome
Hospital Civil de Guadalajara
2017-07-01 PHASE2
NCT03682497 TERMINATED
Heart Failure
AstraZeneca
2018-11-01 PHASE1
NCT02907749 COMPLETED
Cirrhosis; Portal Hypertension
Changqing Yang
2018-01-01 PHASE4
NCT03206658 UNKNOWN
Acute Kidney Injury
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2017-08-01 PHASE3
NCT02948998 UNKNOWN
Hypertrophic Cardiomyopathy; Fibrosis
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2018-05-14 PHASE4
NCT03174288 COMPLETED
Type 1 Diabetes
University of Virginia
2015-08
NCT03909529 COMPLETED
Drug Drug Interaction
CMP Development, LLC
2019-03-10 PHASE1
NCT02673463 UNKNOWN
Atrial Fibrillation
University of Birmingham
2015-01 PHASE4
NCT02689843 COMPLETED
Polycystic Ovary Syndrome
Shiraz University of Medical Sciences
2018-02-01 EARLY_PHASE1
NCT03071263 COMPLETED
Hyperkalemia; Resistant Hypertension
Relypsa, Inc.
2017-01-23 PHASE2
NCT02040441 COMPLETED
Diabetic Nephropathy; Diabetic Retinopathy
Peter Rossing
2014-03 PHASE2; PHASE3
NCT02575963 COMPLETED
AML
Actinium Pharmaceuticals
2012-10 PHASE1; PHASE2
NCT03329443 COMPLETED
Acute Kidney Injury; IHD; Contrast-induced Nephropathy
Alhasan Mujtaba Abdul-Wahid
2017-09-01 PHASE2
NCT02483195 WITHDRAWN
Female Androgenetic Alopecia
University of Florida
2016-08 PHASE4
NCT03981861 COMPLETED
PCOS
Children's Mercy Hospital Kansas City
2016-07-02 PHASE2; PHASE3
NCT01855334 WITHDRAWN
End Stage Renal Disease; Hemodialysis
Brigham and Women's Hospital
2013-09 PHASE4
NCT03291145 COMPLETED
Long Qt Syndrome 1-2; Sudden Cardiac Death
Herlev and Gentofte Hospital
2017-06-27
NCT02236520 COMPLETED
Hypertension
Vanderbilt University
2014-09 PHASE2
NCT02299726 WITHDRAWN
Acute Heart Failure
Indiana University
2015-05 PHASE2
NCT02354352 COMPLETED
Duchenne Muscular Dystrophy
Ohio State University
2015-03-20 PHASE3
NCT02253394 TERMINATED
Pulmonary Arterial Hypertension
Brigham and Women's Hospital
2015-09 PHASE4
NCT02502981 UNKNOWN
Renal Insufficiency, Chronic; Cardio-Renal Syndrome
University Hospital Birmingham
2014-06 PHASE4
NCT02883400 COMPLETED
Transplant, Liver
Wake Forest University Health Sciences
2014-12 PHASE4
NCT02832973 COMPLETED
Hypertension Resistant to Conventional Therapy
Sao Jose do Rio Preto Medical School
2015-09 PHASE4
NCT01198496 UNKNOWN
Hypertension; Stroke; Blood Pressure
Biomedis International Ltd.
2010-10 PHASE4
NCT02501213 TERMINATED
Cancer
Centre Oscar Lambret
2016-05-30 PHASE2
NCT02531412 UNKNOWN
Critically Ill; Cancer
Instituto Nacional de Cancerologia de Mexico
2015-10 PHASE2; PHASE3
NCT00328809 WITHDRAWN
End Stage Renal Disease; Congestive Heart Failure
State University of New York - Upstate Medical University
2013-06-30 PHASE4
NCT02285920 COMPLETED
End-Stage Renal Disease
University of Pennsylvania
2014-11 PHASE2
NCT01973335 COMPLETED
Heart Failure
Hasselt University
2013-11 PHASE4
NCT02585843 COMPLETED
Heart Failure
Columbia University
2015-11 PHASE2; PHASE3
NCT01691053 COMPLETED
End Stage Renal Disease / Hemodialysis
Wuerzburg University Hospital
2012-12 PHASE2
NCT02764619 UNKNOWN
Atrial Fibrillation
Svendborg Hospital
2013-12 PHASE3
NCT01853553 COMPLETED
ADPKD
University of Colorado, Denver
2013-07 PHASE3
NCT01721655 UNKNOWN
Chronic Lung Disease; Bronchopulmonary Dysplasia
West Virginia University Healthcare
2012-10 PHASE2; PHASE3
NCT03314493 COMPLETED
Coronary Artery Calcification; Vascular Calcification
Professor Fernando Figueira Integral Medicine Institute
2014-11-07 PHASE3
NCT01294319 COMPLETED
Cortisol Resistance; Negative Feedback; ACTH; Mineralcorticoid; Glucocorticoid
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2011-01-24 PHASE2
NCT01069510 COMPLETED
Congenital Heart Disease; Heart Failure; Endomyocardial Fibrosis
Oregon Health and Science University
2010-02 PHASE2
NCT03547895 COMPLETED
Decompensated Cirrhosis
Zagazig University
2015-06-01
NCT02235077 COMPLETED
Heart Failure
Duke University
2014-12-30 PHASE2
NCT02047422 WITHDRAWN
Congestive Heart Failure
Yonsei University
2014-01
NCT02190318 UNKNOWN
Chronic Renal Disease
Second Xiangya Hospital of Central South University
2013-11
NCT02429388 WITHDRAWN
Heart Failure
The University of Texas Health Science Center at San Antonio
2014-05 PHASE4
NCT01801228 WITHDRAWN
Ascites; Cirrhosis
Emma Nilsson
2013-02 PHASE2
NCT03744767 COMPLETED
Neovascular Age-related Macular Degeneration
Dr Irmela MANTEL
2014-09-19 PHASE2
NCT01195805 COMPLETED
Essential Hypertension
Regional Hospital Holstebro
2010-08
NCT02417896 UNKNOWN
Acute Kidney Injuries; Kidney Injuries, Acute; Kidney Injury, Acute; Acute Renal Injury; Acute Renal Injuries
Instituto Nacional de Cardiologia Ignacio Chavez
2013-04
NCT02369081 UNKNOWN
Hypertension, Resistant to Conventional Therapy
University of Cambridge
2009-05 PHASE4
NCT01468571 UNKNOWN
Pulmonary Hypertension
Baylor College of Medicine
2011-07 PHASE4
NCT01817803 WITHDRAWN
Congestive Heart Failure
Yonsei University
2013-03
NCT02194465 COMPLETED
Primary Hypertension
Eli Lilly and Company
2014-08 PHASE2
NCT01843309 TERMINATED
Patients With Fungic Infections
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
2013-05 PHASE4
NCT01586442 COMPLETED
Heart Failure; Type 2 Diabetes; Glucose Intolerance
Montreal Heart Institute
2012-03 PHASE3
NCT02046668 COMPLETED
Osteoarthritis, Knee
University of Dundee
2013-11 PHASE4
NCT00604006 COMPLETED
Heart Failure
Monash University
2008-09 PHASE3
NCT01059136 COMPLETED
Myocardial Infarction
Assistance Publique - Hôpitaux de Paris
2010-02 PHASE3
NCT01867294 COMPLETED
Advanced Malignant Neoplasm; Dermatologic Complication
Academic and Community Cancer Research United
2012-08-31 PHASE2
NCT01643434 UNKNOWN
Hypertension
Instituto do Coracao
2012-08 PHASE4
NCT01821703 COMPLETED
Healthy Volunteers
Eli Lilly and Company
2013-05 PHASE1
NCT01406015 COMPLETED
Obesity; Insulin Resistance
Brigham and Women's Hospital
2009-02
NCT00865124 COMPLETED
Type 2 Diabetes Mellitus; Vascular Disease
Brigham and Women's Hospital
2008-09
NCT01510795 UNKNOWN
Kidney Failure, Chronic
Clinical Hospital Merkur
2012-01 PHASE4
NCT00094302 COMPLETED
Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive
Carelon Research
2006-08 PHASE3
NCT01371747 COMPLETED
Chronic Kidney Disease; Hypertension; Hyperkalemia
Relypsa, Inc.
2011-06 PHASE2
NCT00353652 COMPLETED
Hypertension
University of Texas Southwestern Medical Center
2005-01 PHASE4
NCT01552044 COMPLETED
Central Serous Chorioretinitis
Institut National de la Santé Et de la Recherche Médicale, France
2012-01 PHASE1; PHASE2
NCT01128101 UNKNOWN
Renal Failure
UPECLIN HC FM Botucatu Unesp
2011-03 PHASE4
NCT02129621 COMPLETED
Cardiovascular Diseases
Central Hospital, Nancy, France
2010-05
NCT00524615 UNKNOWN
Hypertension
Jan Vaclavík
2007-09 PHASE4
NCT02053974 COMPLETED
Anthracycline Induced Cardiotoxicity
TC Erciyes University
2011-09 PHASE4
NCT02426099 COMPLETED
Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
Sobngwi Eugene
2011-10 PHASE4
NCT01598740 COMPLETED
Heart Failure
Sorbent Therapeutics
2012-06 PHASE1
NCT01103245 COMPLETED
Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders
Vanderbilt University Medical Center
2010-03 PHASE1
NCT01488877 TERMINATED
Type 2 Diabetic Nephropathy
Pfizer
2012-01 PHASE1
NCT00574119 COMPLETED
Heart Failure; Nonischemic Dilated Cardiomyopathy
Vanderbilt University
2007-12 PHASE4
NCT01345656 COMPLETED
Heart Failure
Bayer
2011-05-09 PHASE2
NCT01407471 COMPLETED
Cutaneous Atrophy Due to Corticosteroids
Assistance Publique - Hôpitaux de Paris
2011-09 PHASE2
NCT01897727 COMPLETED
Obstructive Sleep Apnea; Resistant Hypertension; Hyperaldosteronism
University of Alabama at Birmingham
2009-01
NCT01667614 COMPLETED
Type 2 Diabetes Mellitus; Diabetic Nephropathy; Essential Hypertension
Tehran University of Medical Sciences
2010-05 PHASE2
NCT01062763 COMPLETED
Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus
Ib Abildgaard Jacobsen
2010-03 PHASE3
NCT01388088 COMPLETED
Hypertension
Erling Bjerregaard Pedersen
2010-09 PHASE4
NCT00865449 COMPLETED
End Stage Renal Disease
Instituto Nacional de Cardiologia Ignacio Chavez
2008-07 PHASE3
NCT00879060 COMPLETED
Myocardial Fibrosis; Hypertrophic Cardiomyopathy
Tufts Medical Center
2007-11 PHASE4
NCT00226109 SUSPENDED
Cardiomyopathy, Alcoholic; Alcoholism
University of Aarhus
2004-04 PHASE4
NCT01314898 COMPLETED
Healthy Volunteers
Pfizer
2011-03 PHASE1
NCT01526616 COMPLETED
Polycystic Ovary Syndrome
University Magna Graecia
2010-05
NCT00689598 UNKNOWN
Atrial Fibrillation
Taichung Veterans General Hospital
2008-03
NCT01147523 COMPLETED
Fatty Liver; Steatohepatitis
Aristotle University Of Thessaloniki
2010-01 PHASE2
NCT00709137 WITHDRAWN
Hypertension
VA Salt Lake City Health Care System
2008-10
NCT01130597 COMPLETED
Heart Failure
Relypsa, Inc.
2010-05 PHASE2
NCT00811486 WITHDRAWN
Right Heart Failure; Pulmonary Hypertension
University of Colorado, Denver
2009-01
NCT00206232 COMPLETED
Heart Failure
Baylor College of Medicine
2004-07 PHASE4
NCT00141778 COMPLETED
Atrial Fibrillation
Vanderbilt University
2005-04 PHASE2; PHASE3
NCT00857909 COMPLETED
High Blood Pressure
Regional Hospital Holstebro
2009-01 PHASE1
NCT00637078 COMPLETED
Hypertension; Hypercholesterolemia
University of Western Ontario, Canada
2008-02 PHASE4
NCT00523757 COMPLETED
Heart Failure
Justin Ezekowitz
2007-08 PHASE3
NCT01083290 COMPLETED
Healthy
Orion Corporation, Orion Pharma
2010-04 PHASE1
NCT00870402 UNKNOWN
Diabetic Nephropathy
Universidad de los Andes, Chile
2009-03 PHASE4
NCT00865501 COMPLETED
Primary Hypertension
University of Erlangen-Nürnberg Medical School
2008-03 PHASE3
NCT00773084 WITHDRAWN
Diastolic Heart Failure
Texas Tech University Health Sciences Center
2008-09
NCT00292162 COMPLETED
Chronic Heart Failure; Atrial Fibrillation
NHS Greater Glasgow and Clyde
2007-01
NCT00123955 COMPLETED
Diastolic Heart Failure; Heart Failure, Congestive
Wake Forest University
2005-04 PHASE3
NCT00175617 COMPLETED
Female Pattern Hair Loss
University of British Columbia
2005-09 PHASE2
NCT00842140 COMPLETED
Polycystic Ovary Syndrome
University of Sao Paulo
2006-02
NCT00391846 COMPLETED
Heart Failure; Ventricular Dysfunction, Left
AstraZeneca
2006-10 PHASE4
NCT01687699 COMPLETED
End-stage Renal Failure
Dialysis Outcomes Heart Failure Aldactone Study Group
2008-04 PHASE4
NCT00548912 WITHDRAWN
Kidney Failure, Chronic
Dawnmarie DeFazio
2007-10 PHASE4
NCT00741663 COMPLETED
Cirrhosis; Ascites
University of Padova
2005-04 PHASE4
NCT00332904 UNKNOWN
Liver Cirrhosis; Portal Hypertension
Hvidovre University Hospital
2006-08 PHASE4
NCT00295347 COMPLETED
Major Depression
Universitätsklinikum Hamburg-Eppendorf
2005-12
NCT00211081 COMPLETED
Congenital Disorders
Emory University
2004-11
NCT04495712 COMPLETED
Ventricular Arrhythmias
VA Office of Research and Development
2004-07-28 PHASE4
NCT00291720 COMPLETED
Chronic Kidney Disease; Cardiovascular Disease
University Hospital Birmingham
2005-04 PHASE2
NCT01089309 COMPLETED
Arterial Stiffness; Arterial Elasticity
Wolfson Medical Center
2004-05 PHASE4
NCT00860340 COMPLETED
Congestive Heart Failure
University of Toledo Health Science Campus
2003-02
NCT00498537 COMPLETED
Diabetic Nephropathy
US Department of Veterans Affairs
2003-01
NCT00335413 COMPLETED
Hypertension
Steno Diabetes Center Copenhagen
2006-06 PHASE4
NCT00527059 UNKNOWN
Heart Failure; Renal Insufficiency
University of Roma La Sapienza
2007-10 PHASE4
NCT00429897 UNKNOWN
Low-Renin Hypertension
University of Cambridge
2006-08
NCT00188045 TERMINATED
Alcoholic Cirrhosis
University Hospital, Angers
1995-04 PHASE4
NCT00663195 COMPLETED
Chronic Stable Heart Failure
Tottori University Hospital
2004-01 PHASE4
NCT00306696 COMPLETED
Diabetes Mellitus
GlaxoSmithKline
2002-10 PHASE4
NCT00317954 COMPLETED
Diabetic Nephropathy
Steno Diabetes Center Copenhagen
2003-09 PHASE4
NCT00224809 COMPLETED
Cardiovascular Diseases; Heart Diseases; Coronary Disease
Baylor Research Institute
2002-09
NCT00106561 COMPLETED
Kidney Disease; Diabetic Nephropathy; Glomerulonephritis; Proteinuria
Melbourne Health
2002-01 PHASE2; PHASE3
NCT00430794 TERMINATED
Hypertension
Sheffield Teaching Hospitals NHS Foundation Trust
2007-03 PHASE2
NCT00001202 COMPLETED
Precocious Puberty
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1985-01 PHASE2
NCT00125437 TERMINATED
Heart Failure, Congestive
Hebei Medical University
2005-09
NCT00664222 COMPLETED
Chronic Stable Heart Failure
Tottori University Hospital
2004-01 PHASE4
NCT00240656 COMPLETED
Hypertension, Pulmonary
Hebei Medical University
2005-10 PHASE1
NCT00277693 UNKNOWN
Hemodialysis
Universidad de los Andes, Chile
PHASE4
NCT01021943 SUSPENDED
Kidney Transplant
Instituto Nacional de Cardiologia Ignacio Chavez
2009-11 PHASE2
NCT00004311 COMPLETED
Acanthosis Nigricans; Polycystic Ovary Syndrome
National Center for Research Resources (NCRR)
1989-07 PHASE2
NCT00276289 COMPLETED
Idiopathic Hypercalciuria; Hypokalemia Caused by Thiazide Diuretics
Indiana University
2006-01
NCT00528385 COMPLETED
Chronic Kidney Disease; Proteinuria
Medical University of Gdansk
2005-03
NCT00381134 COMPLETED
Diabetes; Kidney Disease; Hypertension
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
2003-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Spironolactone potently binds to and antagonizes the androgen receptor with an IC50 of 77 nM, thereby inhibiting receptor nuclear translocation and downstream transcriptional activation of androgen-responsive genes. This inhibition attenuates androgen-mediated cellular signaling and steroidal physiological effects, providing therapeutic rationale for its clinical investigation in hyperandrogenism associated with polycystic ovary syndrome as well as cardiovascular conditions like heart failure and hypertension.

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.