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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR SPIRONOLACTONE

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Clinical Trials for Spironolactone

Trial ID Title Status Sponsor Phase Summary
NCT00001202 Treatment of Boys With Precocious Puberty Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).
NCT00004311 Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome Completed Baylor College of Medicine Phase 2 OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin. II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.
NCT00004311 Phase II Study of the Effect of Leuprolide Acetate and Spironolactone on Insulin Resistance in Hyperandrogenic Women With Polycystic Ovarian Disease or Hyperandrogenism Insulin Resistance Acanthosis Nigricans Syndrome Completed National Center for Research Resources (NCRR) Phase 2 OBJECTIVES: I. Evaluate insulin resistance in thin and obese hyperandrogenic women with polycystic ovarian disease or hyperandrogenism insulin resistance acanthosis nigricans syndrome and in thin and obese controls, using an estimation of tissue sensitivity to insulin. II. Evaluate the effect of androgen suppression with leuprolide acetate and spironolactone on insulin secretion and resistance.
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00046553 Brain Receptor Function in Post-Traumatic Stress Disorder Completed National Institute of Mental Health (NIMH) N/A The purpose of this study is to examine the function of cortisol receptors in post-traumatic stress disorder (PTSD). Patients with PTSD have neurobiological dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis function. High corticotrophin releasing hormone (CRH) levels and decreased hippocampal volume are major features of the disorder. The mechanisms responsible for these alterations are not known. This study will evaluate the function of cortisol receptors to determine their roles in maintaining PTSD HPA axis dysregulation. Three groups of subjects will take part in the study: Patients with PTSD, healthy control subjects who were exposed to trauma in the past and remained healthy and healthy control subjects who were never traumatized At study entry, the cerebral spinal fluid (CSF) of all participants will be sampled and evaluated. Participants will also undergo a magnetic resonance imaging (MRI) scan of the brain as well as eye blink trace conditioning and neuropsychological tests. Participants will be admitted to the Clinical Center for two nights on three different occasions. At each overnight visits, blood levels of stress hormones will be measured every hour for 26 hours after medication or placebo are given. This will be the end of the study for both groups of healthy control subjects, with the exception that they may be asked to repeat neuropsychologic and eye blink tests after 12 weeks. Participants with PTSD will receive paroxetine for 10 weeks. After 10 weeks these participants will be reevaluated in exactly the same way as before treatment (except they will not repeat the MRI scan).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Spironolactone

Condition Name

Condition Name for Spironolactone
Intervention Trials
Hypertension 21
Heart Failure 20
Polycystic Ovary Syndrome 7
Ascites 7
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Condition MeSH

Condition MeSH for Spironolactone
Intervention Trials
Heart Failure 36
Hypertension 34
Kidney Diseases 22
Renal Insufficiency, Chronic 17
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Clinical Trial Locations for Spironolactone

Trials by Country

Trials by Country for Spironolactone
Location Trials
United States 153
Canada 16
Germany 15
United Kingdom 15
France 13
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Trials by US State

Trials by US State for Spironolactone
Location Trials
Texas 12
Massachusetts 12
Ohio 9
New York 9
Tennessee 9
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Clinical Trial Progress for Spironolactone

Clinical Trial Phase

Clinical Trial Phase for Spironolactone
Clinical Trial Phase Trials
Phase 4 64
Phase 3 22
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Spironolactone
Clinical Trial Phase Trials
Completed 77
Recruiting 33
Not yet recruiting 18
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Clinical Trial Sponsors for Spironolactone

Sponsor Name

Sponsor Name for Spironolactone
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 9
Brigham and Women's Hospital 8
Relypsa, Inc. 6
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Sponsor Type

Sponsor Type for Spironolactone
Sponsor Trials
Other 256
Industry 30
NIH 25
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Colorcon
QuintilesIMS
Mallinckrodt
Harvard Business School
Medtronic
Covington
Fish and Richardson

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