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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR MAXZIDE


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All Clinical Trials for MAXZIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for MAXZIDE

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1Hypertension[disabled in preview]
Condition Name for MAXZIDE
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 MAXZIDE
Intervention Trials
Hypertension 1
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Clinical Trial Locations for MAXZIDE

Trials by Country

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Trials by Country for MAXZIDE
Location Trials
United States 10
Puerto Rico 1
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Trials by US State

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Trials by US State for MAXZIDE
Location Trials
Virginia 1
Tennessee 1
Pennsylvania 1
Ohio 1
Mississippi 1
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Clinical Trial Progress for MAXZIDE

Clinical Trial Phase

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

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

Sponsor Name

trials000001111111US Department of Veterans AffairsVA Office of Research and Development[disabled in preview]
Sponsor Name for MAXZIDE
Sponsor Trials
US Department of Veterans Affairs 1
VA Office of Research and Development 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2U.S. Fed[disabled in preview]
Sponsor Type for MAXZIDE
Sponsor Trials
U.S. Fed 2
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Clinical Trials, Market Analysis, and Projections for MAXZIDE

Introduction to MAXZIDE

MAXZIDE is a combination drug that includes triamterene, a potassium-conserving diuretic, and hydrochlorothiazide, a natriuretic agent. It is primarily used for the treatment of hypertension or edema in patients who are at risk of developing hypokalemia (low potassium levels) when using hydrochlorothiazide alone[1][5].

Clinical Trials and Efficacy

Clinical trials have demonstrated the efficacy and safety of MAXZIDE in managing mild to moderate hypertension. A study involving 156 subjects showed that patients transferred to the new combination formulation of MAXZIDE maintained normal serum electrolyte values, including potassium, with minimal changes in uric acid, creatinine, and blood urea nitrogen levels. The study also observed reductions in systolic and diastolic blood pressure across all study groups[4].

Key Findings

  • Blood Pressure Control: MAXZIDE has been shown to effectively reduce both systolic and diastolic blood pressure in patients with mild to moderate hypertension.
  • Electrolyte Balance: The combination of triamterene and hydrochlorothiazide helps maintain normal serum electrolyte levels, particularly potassium, which is crucial for patients at risk of hypokalemia.
  • Renal Function: The drug does not significantly alter renal function parameters such as creatinine and blood urea nitrogen levels, although periodic monitoring is recommended, especially in patients with mild renal impairment[1][4].

Market Analysis

Current Market Position

MAXZIDE is part of the broader antihypertensive and diuretic market. While it is not a new drug, its niche use in preventing hypokalemia makes it a valuable option for specific patient populations. However, the overall market for antihypertensive drugs is highly competitive and influenced by various factors, including the introduction of new therapies and generic alternatives.

Competitive Landscape

The antihypertensive market is dominated by a variety of drugs, including ACE inhibitors, beta-blockers, and other diuretics. MAXZIDE's unique selling point is its ability to conserve potassium, which is particularly beneficial for patients on concomitant digitalis preparations or those with a history of cardiac arrhythmias. However, this also limits its broader market appeal compared to more versatile antihypertensive agents[1].

Market Projections

General Antihypertensive Market Trends

The global antihypertensive market is expected to grow, driven by increasing prevalence of hypertension and the need for effective management strategies. However, specific projections for MAXZIDE are not readily available due to its niche position.

Impact of Generic and Biosimilar Competition

The antihypertensive market is subject to significant competition from generic and biosimilar drugs. While MAXZIDE itself is not facing immediate generic competition, the broader market trends suggest that generic alternatives to other antihypertensive drugs can impact the sales of branded products. For instance, the patent expiration of blockbuster drugs in other therapeutic areas has led to a shift towards generics, which could indirectly affect the market dynamics for MAXZIDE[2].

Regulatory Considerations

Contraindications and Warnings

MAXZIDE has several contraindications, including anuria, acute and chronic renal insufficiency, significant renal impairment, and hypersensitivity to triamterene or hydrochlorothiazide. It is also contraindicated in patients receiving other potassium-conserving agents or potassium supplementation. These restrictions can limit its market potential but also underscore the need for careful patient selection and monitoring[1].

Monitoring and Safety

Patients on MAXZIDE require frequent monitoring of serum electrolytes, particularly potassium, and renal function parameters. This necessity for close monitoring can impact patient compliance and healthcare resource utilization but is crucial for ensuring the safe use of the drug[1].

Conclusion

MAXZIDE remains a valuable option for managing hypertension and edema in patients at risk of hypokalemia. While it is not a dominant player in the broader antihypertensive market, its unique benefits make it an important choice for specific patient populations.

Key Takeaways

  • Efficacy: MAXZIDE is effective in controlling blood pressure and maintaining electrolyte balance.
  • Market Position: It occupies a niche position in the antihypertensive market due to its potassium-conserving properties.
  • Regulatory Considerations: Close monitoring of serum electrolytes and renal function is necessary.
  • Market Trends: The antihypertensive market is competitive, with significant impact from generic and biosimilar drugs.

FAQs

Q: What is MAXZIDE used for?

A: MAXZIDE is used for the treatment of hypertension or edema in patients who are at risk of developing hypokalemia when using hydrochlorothiazide alone.

Q: What are the key components of MAXZIDE?

A: MAXZIDE combines triamterene, a potassium-conserving diuretic, with hydrochlorothiazide, a natriuretic agent.

Q: What are the contraindications for MAXZIDE?

A: MAXZIDE is contraindicated in patients with anuria, acute and chronic renal insufficiency, significant renal impairment, and hypersensitivity to triamterene or hydrochlorothiazide.

Q: Why is monitoring important for patients on MAXZIDE?

A: Monitoring is crucial to ensure that serum electrolytes, particularly potassium, and renal function parameters remain within normal ranges.

Q: How does MAXZIDE compare to other antihypertensive drugs in the market?

A: MAXZIDE occupies a niche position due to its potassium-conserving properties, making it a valuable option for specific patient populations but limiting its broader market appeal.

Sources

  1. MAXZIDE Label: AccessData FDA, "MAXZIDE (triamterene and hydrochlorothiazide) Label".
  2. NSCLC Market Forecast: Drug Development, "NSCLC Market - Global Drug Forecast & Market Analysis to 2025".
  3. Clinical Trial Supplies Market: GlobeNewswire, "Clinical Trial Supplies Industry Forecast Report 2025-2033".
  4. Clinical Experience with MAXZIDE: PubMed, "Clinical experience with a new combination formulation of triamterene and hydrochlorothiazide (Maxzide)".
  5. MAXZIDE Prescribing Information: Drugs.com, "MAXZIDE (triamterene and hydrochlorothiazide) Package Insert / Prescribing Information".

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