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Spironolactone

Generic Name
Spironolactone
Brand Names
Aldactazide, Aldactone, Carospir, Qaialdo
Drug Type
Small Molecule
Chemical Formula
C24H32O4S
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

Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

Phase 2
Completed
Conditions
Heart Failure
Interventions
First Posted Date
2010-05-26
Last Posted Date
2021-05-12
Lead Sponsor
Relypsa, Inc.
Target Recruit Count
63
Registration Number
NCT01130597
Locations
🇬🇪

Investigator Site 11, Tbilisi, Georgia

🇬🇪

Investigator Site 12, Tbilisi, Georgia

🇸🇮

Investigator Site 22, Maribor, Slovenia

and more 10 locations

Effects of Spironolactone in Dialysis

Phase 4
Conditions
Renal Failure
Interventions
First Posted Date
2010-05-21
Last Posted Date
2011-09-05
Lead Sponsor
UPECLIN HC FM Botucatu Unesp
Target Recruit Count
60
Registration Number
NCT01128101
Locations
🇧🇷

Hospital of the Medical School of Botucatu, Botucatu, São Paulo, Brazil

Effect of Aldosterone Blockade on Arterial Compliance

Phase 4
Completed
Conditions
Arterial Stiffness
Arterial Elasticity
Interventions
First Posted Date
2010-03-18
Last Posted Date
2010-03-29
Lead Sponsor
Wolfson Medical Center
Target Recruit Count
51
Registration Number
NCT01089309
Locations
🇮🇱

Wolfson Medical Center, Holon, Israel

Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-03-09
Last Posted Date
2010-05-10
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
14
Registration Number
NCT01083290
Locations
🇮🇳

Accutest Research Laboratories (I) Pvt. Ltd., Mumbai, India

The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension

Phase 3
Completed
Conditions
Arterial Hypertension
Hypertension, Resistant to Conventional Therapy
Diabetes Mellitus
Interventions
First Posted Date
2010-02-04
Last Posted Date
2014-05-08
Lead Sponsor
Ib Abildgaard Jacobsen
Target Recruit Count
119
Registration Number
NCT01062763

Aldosterone Blockade Early After Acute Myocardial Infarction

Phase 3
Completed
Conditions
Myocardial Infarction
Interventions
First Posted Date
2010-01-29
Last Posted Date
2015-06-11
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
1603
Registration Number
NCT01059136
Locations
🇫🇷

Hôpital PITIE-SALPETRIERE - Institut de Cardiologie, Paris, France

Spironolactone and Prevention of Calcineurin Inhibitor Toxicity in Kidney Transplant Recipients

Phase 2
Suspended
Conditions
Kidney Transplant
Interventions
First Posted Date
2009-12-01
Last Posted Date
2014-07-24
Lead Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
Target Recruit Count
40
Registration Number
NCT01021943
Locations
🇲🇽

Instituto Nacional Nutricion Salvador Zubiran, Mexico, Mexico

Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy

Phase 4
Completed
Conditions
Myocardial Fibrosis
Hypertrophic Cardiomyopathy
Interventions
First Posted Date
2009-04-09
Last Posted Date
2021-04-27
Lead Sponsor
Tufts Medical Center
Target Recruit Count
53
Registration Number
NCT00879060
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

Aldosterone in Diabetic Nephropathy

Phase 4
Conditions
Diabetic Nephropathy
Interventions
First Posted Date
2009-03-27
Last Posted Date
2009-03-27
Lead Sponsor
Universidad de los Andes, Chile
Target Recruit Count
160
Registration Number
NCT00870402
Locations
🇨🇱

University of Los Andes, Santiago, Chile

Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

Phase 3
Completed
Conditions
Primary Hypertension
Interventions
First Posted Date
2009-03-19
Last Posted Date
2012-07-10
Lead Sponsor
University of Erlangen-Nürnberg Medical School
Target Recruit Count
50
Registration Number
NCT00865501
Locations
🇩🇪

University Erlangen-Nürnberg, Nephrology and Hypertension, Erlangen, Germany

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