Spironolactone

Generic Name: Spironolactone

Brand Names: Aldactazide, Aldactone, Carospir, Qaialdo

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₃₂O_₄S

CAS Number: 52-01-7

Unique Ingredient Identifier: 27O7W4T232

Background: Spironolactone is a potassium-sparing diuretic. It binds to mineralocorticoid receptors and functions as aldosterone antagonists. It promotes sodium and water excretion and potassium retention. Spironolactone was originally developed purely for this ability before other pharmacodynamic properties of the drug were discovered. It is indicated to treat several conditions, including heart failure, edema, hyperaldosteronism, and hypertension. Off-label uses of spironolactone include hirsutism, female pattern hair loss, and adult acne vulgaris.

Spironolactone was developed in 1957, marketed in 1959, and approved by the FDA on January 21, 1960.

Indication: Spironolactone is indicated for the treatment of the following conditions:

As spironolactone has antiandrogenic activity, its off-label uses include the treatment of hirsutism, female pattern hair loss, and adult acne vulgaris.

Associated Conditions: Edema, Hypertension, Primary Aldosteronism, Primary Hyperaldosteronism, Secondary hyperaldosteronism, Chronic heart failure with reduced ejection fraction (NYHA Class III), Chronic heart failure with reduced ejection fraction (NYHA Class IV), Idiopathic hyperaldosteronism, Refractory Edema

Associated Therapies: Perioperative drug treatment, Maintenance therapy

Clinical Trials

Spironolactone in the Treatment of Heart Failure

Phase 3

Terminated

Conditions: Heart Failure with Mid-range Ejection Fraction
Heart Failure with Preserved Ejection Fraction

Interventions: Drug: Placebo Comparator

First Posted Date: 2021-01-27

Last Posted Date: 2025-03-28

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 743

Registration Number: NCT04727073

Locations: 🇦🇹
Medical University of Graz, Graz, Austria
🇦🇹
Medical University Innsbruck, Innsbruck, Austria
🇦🇹
Clinic Klagenfurt Wörthersee, Klagenfurt, Austria

and more 66 locations

Does Spironolactone Normalize Sleep-wake Luteinizing Hormone Pulse Frequency in Pubertal Girls With Hyperandrogenism?

Early Phase 1

Recruiting

Conditions: Polycystic Ovary Syndrome
Puberty
Hyperandrogenism

Interventions: Drug: Placebo
Drug: Spironolactone

First Posted Date: 2021-01-26

Last Posted Date: 2023-10-27

Lead Sponsor: University of Virginia

Target Recruit Count: 32

Registration Number: NCT04723862

Locations: 🇺🇸
Center for Research in Reproduction, University of Virginia, Charlottesville, Virginia, United States

Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure

Phase 4

Conditions: Heart Failure Acute
Heart Failure; With Decompensation

Interventions: Drug: Spironolactone

First Posted Date: 2020-11-06

Last Posted Date: 2020-11-10

Lead Sponsor: Laikο General Hospital, Athens

Target Recruit Count: 50

Registration Number: NCT04618601

Locations: 🇬🇷
Laiko General Hospital, Athens, Attiki, Greece

Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne

Phase 4

Recruiting

Conditions: Acne

Interventions: Drug: Doxycycline Hyclate
Drug: Spironolactone

First Posted Date: 2020-10-09

Last Posted Date: 2025-02-06

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 350

Registration Number: NCT04582383

Locations: 🇺🇸
Johnson Dermatology, Fort Smith, Arkansas, United States
🇺🇸
North Texas Center for Clinical Research, Frisco, Texas, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 9 locations

Spironolactone Safety in African Americans with Mild Cognitive Impairment and Early Dementia

Phase 4

Active, not recruiting

Conditions: Mild Cognitive Impairment
Alzheimer Disease

Interventions: Drug: Spironolactone
Drug: Placebo

First Posted Date: 2020-08-21

Last Posted Date: 2024-10-15

Lead Sponsor: Emory University

Target Recruit Count: 30

Registration Number: NCT04522739

Locations: 🇺🇸
Emory Clinic at Executive Park, Atlanta, Georgia, United States

Antiarrhythmic Effects of Spironolactone in Patients With ICDs

Phase 4

Completed

Conditions: Ventricular Arrhythmias

Interventions: Drug: spironolactone
Drug: placebo

First Posted Date: 2020-08-03

Last Posted Date: 2020-10-09

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 90

Registration Number: NCT04495712

Locations: 🇺🇸
VA Portland Health Care System, Portland, OR, Portland, Oregon, United States

Early Sequential Nephron Blockade in Acute Heart Failure Patients: A Randomised, Controlled Study

Phase 3

Conditions: Acute Heart Failure
Acute Kidney Injury

Interventions: Drug: Placebo
Drug: Spironolactone or hydrochlorothiazide

First Posted Date: 2020-07-09

Last Posted Date: 2020-08-18

Lead Sponsor: Chiang Mai University

Target Recruit Count: 100

Registration Number: NCT04465123

Locations: 🇹🇭
Chiang Mai University Hospital, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

The Comparison Between Spironolactone and Indapamide Monotherapy or in Combination With Amlodipine to Reduce the Risk of Heart Failure

Phase 4

Conditions: Hypertension

Interventions: Drug: Indapamide
Drug: Spironolactone

First Posted Date: 2020-07-02

Last Posted Date: 2021-12-08

Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Target Recruit Count: 200

Registration Number: NCT04455178

Locations: 🇨🇳
Kunshan First Renmin Hospital, Kunshan, Jiangsu, China
🇨🇳
Changzhi Heping Hospital, Changzhi, Shanxi, China
🇨🇳
Dongtai Renmin Hospital, Dongtai, Jiangsu, China

and more 1 locations