CLINICAL TRIALS PROFILE FOR ALDACTONE

All Clinical Trials for ALDACTONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001202 ↗	Treatment of Boys With Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1985-01-01	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).
NCT00046553 ↗	Brain Receptor Function in Post-Traumatic Stress Disorder	Completed	National Institute of Mental Health (NIMH)		2002-09-01	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).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	National Institute on Aging (NIA)	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	Wake Forest School of Medicine	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00123955 ↗	PIE II: Pharmacological Intervention in the Elderly II	Completed	Wake Forest University	Phase 3	2005-04-01	The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).
NCT00188045 ↗	Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients	Terminated	University Hospital, Angers	Phase 4	1995-04-01	The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.
NCT00206232 ↗	Novel Treatment for Diastolic Heart Failure in Women	Completed	Baylor College of Medicine	Phase 4	2004-07-01	The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.

Clinical Trial Conditions for ALDACTONE

Condition Name

Condition Name for ALDACTONE
Intervention	Trials
Heart Failure	7
Diabetes Mellitus	2
Diastolic Heart Failure	2
Heart Failure, Congestive	2

Condition MeSH

Condition MeSH for ALDACTONE
Intervention	Trials
Heart Failure	12
Hypertension	4
Heart Failure, Diastolic	3
Cardiomyopathies	3

Clinical Trial Locations for ALDACTONE

Trials by Country

Trials by Country for ALDACTONE
Location	Trials
United States	62
Mexico	3
France	3
United Kingdom	3
Belgium	2

Trials by US State

Trials by US State for ALDACTONE
Location	Trials
Texas	5
Maryland	5
Minnesota	4
California	3
Pennsylvania	3

Clinical Trial Progress for ALDACTONE

Clinical Trial Phase

Clinical Trial Phase for ALDACTONE
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	6
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for ALDACTONE
Clinical Trial Phase	Trials
Completed	20
Unknown status	8
Recruiting	8

Clinical Trial Sponsors for ALDACTONE

Sponsor Name

Sponsor Name for ALDACTONE
Sponsor	Trials
Vanderbilt University	3
Vanderbilt University Medical Center	3
Instituto Nacional de Cardiologia Ignacio Chavez	2

Sponsor Type

Sponsor Type for ALDACTONE
Sponsor	Trials
Other	70
NIH	6
Industry	4

ALDACTONE (Spironolactone): Clinical Trials, Market Analysis, and Projections

Introduction to ALDACTONE (Spironolactone)

ALDACTONE, known generically as spironolactone, is a mineralocorticoid receptor antagonist that has been a cornerstone in the treatment of various medical conditions since its approval in 1960. It is primarily used for its diuretic and antihypertensive properties, acting by competing with aldosterone for receptor sites in the kidneys, leading to increased sodium and water excretion while retaining potassium[5].

Clinical Trials: The RALES Study

One of the most significant clinical trials involving spironolactone is the Randomized Aldactone Evaluation Study (RALES). This study was a placebo-controlled, double-blind trial designed to assess the effect of spironolactone on mortality in patients with severe heart failure and reduced ejection fraction.

Key Findings of RALES

• Mortality Reduction: The trial was terminated early due to the significant mortality benefit observed. Spironolactone reduced the risk of death from all causes by 30% compared to the placebo group (mortality rate: 46% in the placebo group vs. 35% in the spironolactone group)[1][4].
• Hospitalization Reduction: The risk of hospitalization for cardiac causes was also reduced by 30% in the spironolactone group compared to the placebo group[1][4].
• Symptom Improvement: Patients treated with spironolactone showed significant improvements in heart failure symptoms, with 41% of patients experiencing improvements in New York Heart Association (NYHA) class compared to 33% in the placebo group[1].

Other Clinical Uses and Studies

Pediatric and Adult Formulations

Spironolactone is approved for various indications in adults, including heart failure, hypertension, and edema associated with liver cirrhosis or nephrotic syndrome. For pediatric patients, there is a lack of specific prescribing information, but an oral suspension formulation (CaroSpir) has been developed to improve dosing accuracy and consistency. This formulation is approved for adults with indications requiring doses of 100 mg or lower due to higher exposures compared to the tablet form[3].

Dermatological Applications

Beyond its traditional uses, spironolactone has emerging applications in dermatology, particularly for treating acne and hirsutism. This expanded use has contributed to its growing demand across different demographics[2].

Market Analysis

Market Size and Growth

The spironolactone market is expected to grow significantly over the next few years, driven by several key factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of heart failure, hypertension, and other cardiovascular conditions is a major driver of the spironolactone market[2].
• Expanded Use in Dermatology: The use of spironolactone in treating acne, hirsutism, and other hormonal conditions is expanding its market reach[2].
• Improvement in Healthcare Infrastructure: Better healthcare infrastructure in emerging markets is increasing accessibility to spironolactone[2].

Market Drivers

• Preventive Healthcare Models: There is a shift towards preventive healthcare models, which is increasing prescriptions of spironolactone for at-risk patients[2].
• Telemedicine and E-Health Solutions: The advent of telemedicine and e-health solutions is enhancing patient adherence and providing new avenues for market growth[2].

Market Restraints

• Price Sensitivity and Generic Competition: The availability of generic brands and price sensitivity are exerting pressure on the profitability of branded spironolactone drugs[2].
• Limited Awareness Among Healthcare Professionals: There is limited awareness among healthcare professionals about the newer indications of spironolactone, which restricts its widespread utilization[2].

Market Opportunities

• Combination Therapies: Identifying potential in creating combination drugs using spironolactone for enhanced therapeutic effects is a significant opportunity[2].
• Consumer Education Campaigns: Exploring consumer education campaigns to boost awareness of spironolactone's diverse applications can drive market growth[2].

Competitive Landscape

The spironolactone market is competitive, with several key players. A Porter’s Five Forces analysis highlights the need for companies to understand their competitive position and take advantage of strengths while addressing weaknesses.

• Market Penetration: The current market landscape is dominated by key industry players, with detailed data on market share and strategic approaches[2].
• Product Development & Innovation: There is a focus on upcoming technologies, research and development efforts, and notable advancements in product innovation to enhance drug efficacy and patient experience[2].

Future Projections

Market Growth Prospects

The spironolactone market is expected to continue growing, driven by the increasing prevalence of cardiovascular diseases, expanding off-label uses, and advancements in healthcare infrastructure.

• Emerging Markets: There are significant growth prospects in emerging markets, where improving healthcare infrastructure is increasing accessibility to spironolactone[2].
• Innovative Delivery Systems: The development of novel delivery systems and combination therapies is expected to enhance drug efficacy and patient experience, further driving market growth[2].

Challenges and Mitigation Strategies

• Addressing Side Effects: Mitigating consumer concerns over potential side effects is crucial to maintaining spironolactone's trusted reputation. Robust data on safety, especially in off-label applications, is necessary[2].
• Regulatory Hurdles: The market faces regulatory hurdles amidst evolving compliance standards and guidelines. Companies need to stay updated and compliant to navigate these challenges effectively[2].

Key Takeaways

• Clinical Efficacy: Spironolactone has demonstrated significant clinical benefits, particularly in reducing mortality and hospitalization rates in patients with severe heart failure.
• Market Growth: The market is driven by the increasing prevalence of cardiovascular diseases, expanded use in dermatology, and improvements in healthcare infrastructure.
• Innovation and Expansion: Opportunities lie in creating combination therapies, enhancing patient education, and developing novel delivery systems.
• Challenges: The market faces challenges such as price sensitivity, generic competition, and regulatory hurdles, which need to be addressed through strategic innovation.

FAQs

Q: What is the primary mechanism of action of spironolactone?

A: Spironolactone acts as a mineralocorticoid receptor antagonist, competing with aldosterone for receptor sites in the kidneys, leading to increased sodium and water excretion while retaining potassium[5].

Q: What were the key findings of the RALES study?

A: The RALES study found that spironolactone reduced the risk of death from all causes by 30% and the risk of hospitalization for cardiac causes by 30% compared to the placebo group[1][4].

Q: What are the emerging applications of spironolactone?

A: Spironolactone has emerging applications in dermatology, particularly for treating acne, hirsutism, and other hormonal conditions such as polycystic ovary syndrome (PCOS)[2].

Q: What are the major drivers of the spironolactone market?

A: The major drivers include the increasing prevalence of cardiovascular diseases, expanded use in dermatology, and improvements in healthcare infrastructure in emerging markets[2].

Q: What challenges does the spironolactone market face?

A: The market faces challenges such as price sensitivity, generic competition, limited awareness among healthcare professionals, and regulatory hurdles[2].

Sources

1. Randomized Aldactone Evaluation Study - RALES. American College of Cardiology.
2. Spironolactone Drugs Market Size & Share 2025-2030. 360 Research Reports.
3. Model-Informed Optimization of a Pediatric Clinical Pharmacokinetic Study. MDPI.
4. ALDACTONE® (spironolactone) Clinical Studies. Pfizer Medical Information.
5. Spironolactone - Drug Targets, Indications, Patents. Patsnap Synapse.