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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE


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All Clinical Trials for Spironolactone And Hydrochlorothiazide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 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.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 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.
NCT00224549 ↗ PHARES Study: Management of Resistant Hypertension Completed Assistance Publique - Hôpitaux de Paris Phase 4 2005-04-01 The purpose of this study is to assess the efficacy of two different treatment regimens for treating resistant hypertension previously uncontrolled with at least 3 antihypertensive treatments. The study hypothesis is that these two regimens (one based on increasing diuretics and the other based on increasing renin angiotensin system blockage) may not differ in terms of efficacy.
NCT00515021 ↗ Diurnal Variation of Plasminogen Activator Inhibitor-1 Completed National Center for Research Resources (NCRR) Phase 4 2007-04-01 To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
NCT00515021 ↗ Diurnal Variation of Plasminogen Activator Inhibitor-1 Completed Vanderbilt University Medical Center Phase 4 2007-04-01 To determine if nighttime administration of an aldosterone antagonist would effectively lower peak plasma Plasminogen Activator Inhibitor-1 (PAI-1) levels more effectively than morning administration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Spironolactone And Hydrochlorothiazide

Condition Name

Condition Name for Spironolactone And Hydrochlorothiazide
Intervention Trials
Hypertension 4
Acute Heart Failure 1
Acute Kidney Injury 1
Blood Pressure 1
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Condition MeSH

Condition MeSH for Spironolactone And Hydrochlorothiazide
Intervention Trials
Hypertension 4
Syndrome 1
Diabetes Mellitus 1
Nephrotic Syndrome 1
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Clinical Trial Locations for Spironolactone And Hydrochlorothiazide

Trials by Country

Trials by Country for Spironolactone And Hydrochlorothiazide
Location Trials
United States 12
France 1
China 1
Mexico 1
Thailand 1
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Trials by US State

Trials by US State for Spironolactone And Hydrochlorothiazide
Location Trials
Tennessee 2
Massachusetts 1
Virginia 1
Pennsylvania 1
Ohio 1
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Clinical Trial Progress for Spironolactone And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Spironolactone And Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
N/A 2
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Clinical Trial Status

Clinical Trial Status for Spironolactone And Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 4
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Spironolactone And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Spironolactone And Hydrochlorothiazide
Sponsor Trials
National Center for Research Resources (NCRR) 1
Vanderbilt University Medical Center 1
National Heart, Lung, and Blood Institute (NHLBI) 1
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Sponsor Type

Sponsor Type for Spironolactone And Hydrochlorothiazide
Sponsor Trials
Other 8
NIH 3
U.S. Fed 2
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Spironolactone and Hydrochlorothiazide: Clinical Trials, Market Analysis, and Projections

Introduction

Spironolactone and hydrochlorothiazide is a combination medication used to treat various conditions, including hypertension, edema, and heart, liver, or kidney diseases. This article will delve into the clinical trials, market analysis, and future projections for this drug.

Mechanism of Action

The combination of spironolactone and hydrochlorothiazide works through complementary mechanisms. Spironolactone acts as an aldosterone receptor antagonist, reducing the loss of potassium and increasing the excretion of sodium and water by the kidneys. Hydrochlorothiazide, a thiazide diuretic, inhibits the reabsorption of sodium and water in the cortical diluting segment of the distal renal tubule, further enhancing diuretic and antihypertensive effects[1][4][5].

Clinical Trials

Several clinical trials have evaluated the efficacy and safety of spironolactone and hydrochlorothiazide.

Efficacy in Hypertension

A double-blind study involving 49 patients with mild-to-moderate essential hypertension showed that the combination of spironolactone and hydrochlorothiazide significantly lowered blood pressure. The mean arterial blood pressure fell to levels of less than or equal to 107 mm Hg or declined by more than 15 mm Hg in 78% of the patients after twelve weeks of treatment[3].

Side Effects and Safety

The same study highlighted that while hydrochlorothiazide alone often resulted in serum potassium levels below 3.5 mEq/L, spironolactone helped maintain potassium levels. However, spironolactone was associated with side effects such as gynecomastia, particularly at higher doses. Uric acid levels increased in all patients, more so in those on hydrochlorothiazide, but clinical gout did not develop[3].

Market Analysis

Current Market Trends

The global hydrochlorothiazide market, which includes the combination with spironolactone, is driven by several key factors:

  • Increasing Prevalence of Hypertension: With an estimated 1.13 billion people suffering from hypertension worldwide, and this number expected to rise, the demand for antihypertensive medications like spironolactone and hydrochlorothiazide is increasing[2].
  • Growing Geriatric Population: The rise in the geriatric population, who are more prone to hypertension and other cardiovascular diseases, is another driving factor[2].
  • Healthcare Expenditure and R&D: Increased healthcare expenditure and research & development activities by pharmaceutical companies are also boosting the market[2].

Market Growth Projections

The hydrochlorothiazide market, including its combination with spironolactone, is expected to grow significantly by 2030. This growth is fueled by the increasing prevalence of hypertension, coronary artery disease, and the need for effective antihypertensive treatments. According to market research, the global hydrochlorothiazide market is quantitatively analyzed to highlight the market growth scenario, with new product launches and increased awareness for heart disease treatments contributing to this growth[2].

Challenges and Restraints

Despite the positive market trends, there are several challenges that could hamper the growth of the spironolactone and hydrochlorothiazide market:

  • Side Effects: Side effects associated with hydrochlorothiazide, such as hypokalemia, hypomagnesemia, and the increased risk of non-melanoma skin cancer, particularly squamous cell carcinoma, are significant concerns[5].
  • Drug Interactions: Interactions with other medications, such as acetylsalicylic acid and digoxin, which can reduce the efficacy or increase the toxicity of spironolactone and hydrochlorothiazide, need careful management[1].

Future Projections

Market Opportunities

The future of the spironolactone and hydrochlorothiazide market looks promising due to several factors:

  • Increasing Demand for Antihypertensives: The rising global prevalence of hypertension and related cardiovascular diseases will continue to drive the demand for effective antihypertensive medications[2].
  • Advancements in R&D: Ongoing research and development in the pharmaceutical sector are likely to lead to new formulations and improved versions of existing medications, including spironolactone and hydrochlorothiazide combinations[2].

Competitive Landscape

The market for spironolactone and hydrochlorothiazide is competitive, with several pharmaceutical companies involved in the production and distribution of these medications. Porter’s five forces analysis indicates a balanced market where buyers and suppliers have moderate bargaining power, suggesting a competitive yet stable market environment[2].

Key Takeaways

  • Efficacy in Hypertension: Spironolactone and hydrochlorothiazide are effective in lowering blood pressure and managing edema in various conditions.
  • Market Growth: The market is expected to grow driven by increasing hypertension prevalence, geriatric population, and healthcare expenditure.
  • Challenges: Side effects, drug interactions, and the need for careful patient monitoring are significant challenges.
  • Future Projections: The market is poised for growth with ongoing R&D and increasing demand for antihypertensive medications.

FAQs

Q: What conditions are spironolactone and hydrochlorothiazide used to treat?

A: Spironolactone and hydrochlorothiazide are used to treat high blood pressure, edema caused by heart, liver, or kidney disease, and other conditions involving fluid retention[4].

Q: How do spironolactone and hydrochlorothiazide work together?

A: Spironolactone acts as an aldosterone antagonist, reducing potassium loss, while hydrochlorothiazide inhibits sodium and water reabsorption in the kidneys, enhancing diuretic and antihypertensive effects[1][4][5].

Q: What are the common side effects of spironolactone and hydrochlorothiazide?

A: Common side effects include gynecomastia, hypokalemia, hypomagnesemia, and increased uric acid levels. There is also an increased risk of non-melanoma skin cancer associated with hydrochlorothiazide[3][5].

Q: Can spironolactone and hydrochlorothiazide interact with other medications?

A: Yes, they can interact with medications like acetylsalicylic acid and digoxin, which may require dose adjustments and close monitoring[1].

Q: What is the projected market growth for spironolactone and hydrochlorothiazide?

A: The market is expected to grow significantly by 2030, driven by the increasing prevalence of hypertension and other cardiovascular diseases, as well as advancements in R&D[2].

Sources

  1. Pfizer: Spironolactone and Hydrochlorothiazide Tablets.
  2. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030).
  3. PubMed: Hydrochlorothiazide and spironolactone in hypertension.
  4. MedlinePlus: Spironolactone and Hydrochlorothiazide.
  5. FDA: Aldactazide® spironolactone and hydrochlorothiazide tablets.

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