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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

Aldosterone Blockade in Heart Failure

Phase 3
Completed
Conditions
Heart Failure
Interventions
First Posted Date
2007-08-31
Last Posted Date
2018-11-07
Lead Sponsor
Justin Ezekowitz
Target Recruit Count
8
Registration Number
NCT00523757
Locations
🇨🇦

University of Alberta Hospital, Edmonton, Alberta, Canada

Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

Not Applicable
Completed
Conditions
Diabetic Nephropathy
Interventions
First Posted Date
2007-07-10
Last Posted Date
2008-10-17
Lead Sponsor
US Department of Veterans Affairs
Target Recruit Count
30
Registration Number
NCT00498537
Locations
🇺🇸

VA Medical Center, Dayton, Dayton, Ohio, United States

The Efficacy of Spironolactone in Patients With Resistant Hypertension

Phase 2
Terminated
Conditions
Hypertension
First Posted Date
2007-02-02
Last Posted Date
2010-12-06
Lead Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Target Recruit Count
40
Registration Number
NCT00430794
Locations
🇬🇧

Clinical Research Facility, Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom

Double Blind Crossover Comparison of Diuretics in the Young

Not Applicable
Conditions
Low-Renin Hypertension
First Posted Date
2007-02-01
Last Posted Date
2007-02-01
Lead Sponsor
University of Cambridge
Target Recruit Count
30
Registration Number
NCT00429897
Locations
🇬🇧

University of Cambridge - Addenbrookes Hospital, Cambridge, United Kingdom

Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone

Phase 4
Completed
Conditions
Heart Failure
Ventricular Dysfunction, Left
Interventions
Drug: Diuretics
Drug: HF treatment according to Swedish guidelines
Procedure: Blood samples
Procedure: The Kansas City Cardiomyopathy Questionnaire (KCCQ)
First Posted Date
2006-10-25
Last Posted Date
2012-06-25
Lead Sponsor
AstraZeneca
Target Recruit Count
252
Registration Number
NCT00391846
Locations
🇸🇪

Research Site, Vaxjo, Sweden

Improving Outcomes in Patients With Kidney Disease Due to Diabetes

Phase 2
Completed
Conditions
Diabetes
Kidney Disease
Hypertension
First Posted Date
2006-09-27
Last Posted Date
2010-03-02
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
92
Registration Number
NCT00381134
Locations
🇺🇸

The University of Texas Southwestern Medical Center, Dallas, Texas, United States

Effects of Thiazide Diuretics on Sympathetic Nervous System in Hypertension

Phase 4
Completed
Conditions
Hypertension
Interventions
First Posted Date
2006-07-19
Last Posted Date
2019-02-06
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
166
Registration Number
NCT00353652
Locations
🇺🇸

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

Phase 4
Completed
Conditions
Hypertension
First Posted Date
2006-06-09
Last Posted Date
2008-06-05
Lead Sponsor
Steno Diabetes Center Copenhagen
Target Recruit Count
17
Registration Number
NCT00335413

Effect of Betablocker or Aldosterone Antagonist Therapy on Patients With Liver Cirrhosis

Phase 4
Conditions
Liver Cirrhosis
Portal Hypertension
Interventions
First Posted Date
2006-06-02
Last Posted Date
2010-06-04
Lead Sponsor
Hvidovre University Hospital
Target Recruit Count
22
Registration Number
NCT00332904
Locations
🇩🇰

Department of Clinical Physiology and Nuclear Medicine, and Department for Gastrointestinal Medicine, Hvidovre Hospital, Hvidovre, Denmark

Spironolactone Safety in Dialysis Patients

Phase 4
Withdrawn
Conditions
End Stage Renal Disease
Congestive Heart Failure
Interventions
First Posted Date
2006-05-22
Last Posted Date
2020-10-22
Lead Sponsor
State University of New York - Upstate Medical University
Registration Number
NCT00328809
Locations
🇺🇸

SUNY Upstate Medical University, Syracuse, New York, United States

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