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Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR HYDROFLUMETHIAZIDE


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All Clinical Trials for hydroflumethiazide

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01260857 ↗ Safety And Efficacy Of Spirinolactone Plus Hydroflumethiazide In The Treatment Of Filipino Patients With Hypertension Withdrawn Pfizer 2013-03-01 Aldazide 25 mg OD will be given to Filipino hypertensive patients, and there will be 2 follow-up visits on week 4 and week 8 to monitor for safety and efficacy as primary and secondary outcomes, respectively.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

Clinical Trial Conditions for hydroflumethiazide

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Hypertension[disabled in preview]
Condition Name for hydroflumethiazide
Intervention Trials
Hypertension 1
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Condition MeSH

10-0.100.10.20.30.40.50.60.70.80.911.1Hypertension[disabled in preview]
Condition MeSH for hydroflumethiazide
Intervention Trials
Hypertension 1
[disabled in preview] 0
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Clinical Trial Progress for hydroflumethiazide

Clinical Trial Phase

0[disabled in preview]
Clinical Trial Phase for hydroflumethiazide
Clinical Trial Phase Trials
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Withdrawn[disabled in preview]
Clinical Trial Status for hydroflumethiazide
Clinical Trial Phase Trials
Withdrawn 1
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Clinical Trial Sponsors for hydroflumethiazide

Sponsor Name

trials000001111111Pfizer[disabled in preview]
Sponsor Name for hydroflumethiazide
Sponsor Trials
Pfizer 1
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Sponsor Type

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Industry[disabled in preview]
Sponsor Type for hydroflumethiazide
Sponsor Trials
Industry 1
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Hydroflumethiazide: Clinical Trials, Market Analysis, and Projections

Introduction

Hydroflumethiazide, a thiazide diuretic, is widely used in the treatment of hypertension and edema associated with congestive heart failure and liver cirrhosis. This article delves into the clinical trials, market analysis, and future projections for this medication.

Mechanism of Action

Hydroflumethiazide works by inhibiting the sodium-chloride symporter (SLC12A3) in the distal convoluted tubule of the kidneys, which reduces sodium and chloride reabsorption and increases water loss from the body. This mechanism is crucial for its diuretic and antihypertensive effects[2].

Clinical Trials

Efficacy and Comparison Studies

One notable study compared the efficacy of hydroflumethiazide with meralluride (Mercuhydrin) in clearing edema. Hydroflumethiazide was found to have 67% the efficacy of meralluride, which is significantly higher than chlorothiazide's 40% efficacy in a previous study[1].

Post-Marketing Surveillance

An open-label, observational post-marketing surveillance study was conducted to assess the safety and efficacy of a combination of spironolactone and hydroflumethiazide (Aldazide) in Filipino patients with stage 1 to 2 hypertension. The study involved administering Aldazide 25 mg once daily and monitoring patients at week 4 and week 8 for safety and efficacy outcomes. Although the study was withdrawn, it highlights ongoing efforts to evaluate the safety and efficacy of hydroflumethiazide in various patient populations[5].

Market Analysis

Current Market Position

Hydroflumethiazide is an established medication in the diuretic market, particularly among thiazide diuretics. Its use is widespread due to its effectiveness in managing hypertension and edema. The market for diuretics is significant, driven by the high prevalence of cardiovascular diseases and the need for effective blood pressure management.

Competitive Landscape

The diuretic market is competitive, with several other thiazide diuretics like hydrochlorothiazide and non-thiazide diuretics like furosemide and metolazone. However, hydroflumethiazide maintains a strong position due to its specific pharmacological profile and clinical efficacy.

Projections and Future Outlook

Growing Demand for Hypertension Management

The global prevalence of hypertension is increasing, driven by factors such as aging populations, lifestyle changes, and rising obesity rates. This trend is expected to drive the demand for antihypertensive medications, including hydroflumethiazide.

Advancements in Combination Therapies

There is a growing interest in combination therapies that include diuretics like hydroflumethiazide. For instance, the combination of spironolactone and hydroflumethiazide (Aldazide) is being explored for its potential in managing hypertension more effectively. Such combinations could expand the market share of hydroflumethiazide[5].

Regulatory and Safety Considerations

Regulatory bodies continue to monitor the safety and efficacy of hydroflumethiazide. Any new findings or updates in clinical trials could impact its market position. For example, close monitoring of adverse effects such as electrolyte imbalances, dehydration, and CNS depression is crucial for maintaining its approval status[2][4].

Adverse Effects and Safety Profile

Common Adverse Effects

Hydroflumethiazide can cause several adverse effects, including diuresis, lethargy, coma in severe cases, and significant serum electrolyte changes or dehydration. Other common side effects include hypokalemia, hyperuricemia, and hemodynamic changes due to plasma volume depletion[2][4].

Toxicity and Overdose

Overdoses of hydroflumethiazide can lead to severe diuresis, lethargy progressing to coma, and minimal cardiorespiratory depression. Immediate evacuation of stomach contents and close monitoring are advised in such cases, although dialysis is not likely to be effective[4].

Economic Evaluation

Cost-Effectiveness

The cost-effectiveness of hydroflumethiazide is an important consideration, especially in comparison with other diuretics. Economic evaluations often involve assessing the incremental cost-effectiveness ratios (ICERs) and quality-adjusted life-years (QALYs) to determine the value for money. Given its established efficacy and safety profile, hydroflumethiazide is likely to remain a cost-effective option for managing hypertension and edema[3].

Key Takeaways

  • Efficacy: Hydroflumethiazide is effective in treating hypertension and edema, with a significant efficacy profile compared to other thiazide diuretics.
  • Market Position: It holds a strong position in the diuretic market due to its established use and clinical efficacy.
  • Future Outlook: Growing demand for hypertension management and advancements in combination therapies are expected to drive its market.
  • Safety Profile: Close monitoring of adverse effects is crucial to maintain its safety profile.
  • Economic Evaluation: It remains a cost-effective option for managing hypertension and edema.

FAQs

What is hydroflumethiazide used for?

Hydroflumethiazide is used to treat hypertension and edema due to congestive heart failure and liver cirrhosis.

How does hydroflumethiazide work?

It inhibits the sodium-chloride symporter in the distal convoluted tubule of the kidneys, reducing sodium and chloride reabsorption and increasing water loss.

What are the common adverse effects of hydroflumethiazide?

Common adverse effects include diuresis, lethargy, hypokalemia, hyperuricemia, and hemodynamic changes due to plasma volume depletion.

Can hydroflumethiazide be used in combination with other medications?

Yes, it is often used in combination with other medications, such as spironolactone, to enhance its therapeutic effects.

What happens in case of an overdose of hydroflumethiazide?

Overdose can lead to severe diuresis, lethargy progressing to coma, and significant serum electrolyte changes. Immediate medical attention is required.

Sources

  1. Gold, H. (1961). Comparison of Hydroflumethiazide and Meralluride: New ... JAMA, [Abstract].
  2. DrugBank. (2005). Hydroflumethiazide: Uses, Interactions, Mechanism of Action.
  3. NIHR. (n.d.). A systematic review and economic evaluation of the clinical effectiveness and cost-effectiveness of aldosterone antagonists in post-myocardial infarction heart failure.
  4. FDA. (2019). Metolazone Tablets, USP Rx Only.
  5. Patsnap. (n.d.). Hydroflumethiazide - Drug Targets, Indications, Patents.

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