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 Therapy In Young Women With NASH

Phase 1

Completed

Conditions: NASH - Nonalcoholic Steatohepatitis

Interventions: Drug: Spironolactone 100mg
Drug: Placebo oral capsule

First Posted Date: 2018-07-03

Last Posted Date: 2025-03-26

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 20

Registration Number: NCT03576755

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States

Spironolactone and Perioperative Atrial Fibrillation Occurrence in Cardiac Surgery Patients.

Phase 3

Conditions: Cardiac Surgery
Atrial Fibrillation
Aldosterone Blockade

Interventions: Drug: Spironolactone 25mg
Drug: Placebo oral capsule

First Posted Date: 2018-06-11

Last Posted Date: 2019-03-05

Lead Sponsor: University Hospital, Caen

Target Recruit Count: 1500

Registration Number: NCT03551548

Locations: 🇫🇷
CHU Caen, Caen, Normandy, France
🇫🇷
Gaillard, Caen, Normandy, France

Management of Decompensated HCV Cirrhotic Patients

Not Applicable

Completed

Conditions: Decompensated Cirrhosis

Interventions: Drug: Sofosbuvir 400mg (Sovaldi) + Daclatasvir 60 mg (Daklinza) + Ribavirin 200 mg (Rebetol)
Drug: vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion

First Posted Date: 2018-06-06

Last Posted Date: 2018-12-05

Lead Sponsor: Zagazig University

Target Recruit Count: 80

Registration Number: NCT03547895

Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy

Phase 4

Recruiting

Conditions: Renal Insufficiency, Chronic
Diabetic Nephropathy Type 2

Interventions: Drug: Renin-Angiotensin (RAAS) blockers in combination with Spironolactone
Drug: Renin-Angiotensin (RAAS) alone

First Posted Date: 2018-04-18

Last Posted Date: 2022-10-28

Lead Sponsor: James A. Tumlin, MD

Target Recruit Count: 72

Registration Number: NCT03502031

Locations: 🇺🇸
Nelson Kopyt, MD, Bethlehem, Pennsylvania, United States
🇺🇸
Georgia Nephrology Research Institute, Lawrenceville, Georgia, United States

Hypoglycemia and Autonomic Nervous System Function-B

Phase 4

Conditions: Hypoglycemia
Healthy

Interventions: Drug: Placebo
Drug: Spironolactone
Other: Hypoglycemic Hyperinsulinemic Clamp
Other: Euglycemic Hyperinsulinemic Clamp

First Posted Date: 2018-02-12

Last Posted Date: 2022-07-20

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 28

Registration Number: NCT03429946

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Spironolactone Therapy in Chronic Stable Right HF Trial

Phase 4

Completed

Conditions: Pulmonary Hypertension, Primary, 2
Chronic Right-Sided Heart Failure
Pulmonary Arterial Hypertension
Pulmonary Hypertension, Primary, 3
Pulmonary Hypertension, Primary, 4
Cardiomyopathy Right Ventricular