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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR HYDROCHLOROTHIAZIDE


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505(b)(2) Clinical Trials for Hydrochlorothiazide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Indication NCT04495608 ↗ Fluconazole in Hypercalciuric Patients With Increased 1,25(OH)2D Levels Recruiting Hospices Civils de Lyon Phase 2 2021-01-13 Hypercalciuria is one of the most frequent metabolic disorders associated with nephrolithiasis and/or nephrocalcinosis leading to Chronic Kidney Disease (CKD) and bone complications in adults. Hypercalciuria can be secondary to increased intestinal absorption and/or increased renal distal tubular reabsorption of calcium due to increased active vitamin D, i.e. 1,25(OH)2D, levels. The management of hypercalciuria is challenging. Classic management based on hyperhydration and dietary advice has low impact on calciuria and therefore on CKD progression. Other strategies such as hydrochlorothiazide can be proposed, however with an uncertain medical benefit in view of side effects (hypokalemia, asthenia, potential cutaneous long-term side effects). Azoles are known to inhibit the 1α-hydroxylase and therefore decrease 1,25(OH)2D levels. These antifungal drugs are commonly used in neonates, infants and adults; pharmacokinetic data are well described. Recently, to improve azoles tolerance, fluconazole has been successfully reported to reduce calciuria in patients with CYP24A1 mutation (1 adult) or NPTIIc mutations (1 child), while maintaining a stable renal function. Based on these observations, the investigators hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. The primary objective is to demonstrate that fluconazole normalizes or decreases calciuria after 4 months of treatment in patients with hypercalciuria and increased 1,25(OH)2D levels. The secondary objectives aim to describe: - the effects of fluconazole on the evolution over time of the calcium/phosphate metabolism, - the evolution of renal function, - the cohort at Baseline and after 4 months of treatment period, - the safety of fluconazole, - the onset of potential mycological resistances, - and the treatment compliance. This is a prospective, interventional, national, randomized in 2 parallel groups (1:1), controlled versus placebo, double blind trial. This study will involve patients between 10 and 50 years of age suffering from nephrolithiasis and/or nephrocalcinosis with hypercalciuria (> 0.1 mmol/kg/d) and increased 1,25 (OH)2D levels (≥ 150 pmol/l) and 25-OH-D levels (≥50 nmol/L). FLUCOLITH study is a unique opportunity to develop a new indication of a well-known and not expensive drug (e.g. fluconazole) in rare renal diseases, the ultimate objective being the secondary prevention of CKD worsening in these patients. If the results of this proof-of-concept randomized controlled trial are positive, the investigators will propose an extension phase to evaluate the long term efficacy and safety of fluconazole on renal and bone parameters.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hydrochlorothiazide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000525 ↗ Diuretics, Hypertension, and Arrhythmias Clinical Trial Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1986-07-01 To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
NCT00000525 ↗ Diuretics, Hypertension, and Arrhythmias Clinical Trial Completed University of California, San Francisco Phase 3 1986-07-01 To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.
NCT00005520 ↗ Genetic Epidemiology of Responses to Antihypertensives Completed National Heart, Lung, and Blood Institute (NHLBI) 1997-02-01 To determine whether measured variation in genes coding for components of vasoconstriction and volume regulating systems predict interindividual differences in blood pressure response to therapy with a thiazide diuretic, hydrochlorothiazide, or an angiotensin II receptor blocker, candesartan, in hypertensive African-Americans (N=300 treated with each drug) and in hypertensive European Americans (N=300 treated with each drug).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrochlorothiazide

Condition Name

Condition Name for Hydrochlorothiazide
Intervention Trials
Hypertension 218
Healthy 36
Essential Hypertension 31
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Condition MeSH

Condition MeSH for Hydrochlorothiazide
Intervention Trials
Hypertension 263
Essential Hypertension 53
Diabetes Mellitus 21
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Clinical Trial Locations for Hydrochlorothiazide

Trials by Country

Trials by Country for Hydrochlorothiazide
Location Trials
United States 695
Germany 72
Canada 46
Japan 42
Spain 32
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Trials by US State

Trials by US State for Hydrochlorothiazide
Location Trials
Texas 37
Florida 33
New Jersey 31
California 31
North Carolina 25
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Clinical Trial Progress for Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 133
Phase 3 105
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 304
Unknown status 23
Terminated 16
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Clinical Trial Sponsors for Hydrochlorothiazide

Sponsor Name

Sponsor Name for Hydrochlorothiazide
Sponsor Trials
Novartis 54
Boehringer Ingelheim 36
Merck Sharp & Dohme Corp. 17
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Sponsor Type

Sponsor Type for Hydrochlorothiazide
Sponsor Trials
Industry 290
Other 251
NIH 11
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Hydrochlorothiazide: Clinical Trials, Market Analysis, and Projections

Introduction to Hydrochlorothiazide

Hydrochlorothiazide (HCTZ), a thiazide diuretic, has been a cornerstone in the treatment of hypertension, edema, and other conditions for over six decades. First approved on February 12, 1959, HCTZ works by inhibiting the sodium-chloride cotransporter in the distal convoluted tubule of the kidney, leading to increased excretion of water and electrolytes, which in turn reduces blood pressure and edema[4].

Recent Clinical Trials: Diuretic Comparison Project (DCP)

One of the most significant recent clinical trials involving HCTZ is the Diuretic Comparison Project (DCP), conducted by the Veterans Affairs (VA) health system. This pragmatic trial aimed to compare the efficacy and safety of HCTZ with chlorthalidone (CTD), another thiazide diuretic, in elderly veterans with hypertension.

Study Design and Participants

The DCP trial randomized over 13,500 veterans who were already taking HCTZ to either continue on HCTZ or switch to an equivalent dose of CTD. The trial was notable for its embedded design within usual clinical care, involving no additional staff or extra visits for participants[1][3].

Key Findings

The primary outcome of the trial was major adverse cardiovascular events (MACE), which showed no significant difference between the two groups: 10.4% for CTD vs. 10.0% for HCTZ. Secondary outcomes, including hospitalizations for myocardial infarction, stroke, and heart failure, also did not differ significantly between the groups. However, patients with prior myocardial infarction or stroke showed a potential benefit with CTD, though this was considered a hypothesis-generating finding within the context of an overall negative trial. Hypokalemia was more common in the CTD group[3].

Implications

The DCP trial's results suggest that current clinical guidelines recommending CTD over HCTZ for better blood pressure control may not be supported by direct evidence. This study underscores the importance of real-world evidence in guiding treatment decisions, especially given the widespread use of these medications[1][3].

Market Analysis and Projections

Global Market Growth

The global Hydrochlorothiazide market is projected to experience significant growth from 2024 to 2030. According to market research, the market is expected to grow at a Compound Annual Growth Rate (CAGR) during this period, driven by increasing demand for hypertension treatments and other applications such as fluid retention and kidney calculi[2][5].

Regional Market Dynamics

  • North America: The US and Canada markets are expected to see substantial growth, driven by the high prevalence of hypertension and the aging population.
  • Europe: The European market is also anticipated to grow, with countries like Germany, the UK, and Italy contributing significantly.
  • Asia-Pacific: China, Japan, and India are expected to be key growth regions, driven by increasing healthcare spending and a growing elderly population[2][5].

Key Manufacturers and Market Share

The global Hydrochlorothiazide market is dominated by several key manufacturers, including Polpharma API, LGM Pharma, Octavius Pharma, Cambrex, and Changzhou Pharmaceutical Factory. These companies hold a significant share of the market in terms of revenue and production capacity[2].

Market Segmentation

The market is segmented by type (tablet, capsule, and liquid), application (hypertension, fluid retention, heart attack, kidney failure, and others), and end-user (hospitals, drug stores, and others). The hypertension segment is the largest application area, reflecting the widespread use of HCTZ in managing high blood pressure[5].

Market Drivers and Restraints

Drivers

  • Increasing Prevalence of Hypertension: The growing global prevalence of hypertension, particularly among the elderly, drives the demand for HCTZ.
  • Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure and access to medications in developing countries contribute to market growth.
  • Cost-Effectiveness: HCTZ is a cost-effective treatment option, making it a preferred choice in many healthcare systems[5].

Restraints

  • Side Effects and Adverse Reactions: HCTZ can cause side effects such as hypokalemia, low blood pressure, and electrolyte imbalances, which can limit its use in certain patient populations.
  • Compliance and Adherence: Patient compliance with long-term medication regimens can be a challenge, affecting the overall effectiveness of HCTZ treatment[4].

Future Outlook

Emerging Trends

  • Personalized Medicine: There is a growing trend towards personalized medicine, which could influence the use of HCTZ based on individual patient profiles and genetic factors.
  • Combination Therapies: The development of combination therapies involving HCTZ and other antihypertensive drugs is expected to continue, offering more treatment options for patients[5].

Regulatory Environment

Regulatory changes and updates in clinical guidelines will continue to shape the market for HCTZ. For instance, the findings from the DCP trial may lead to revisions in treatment guidelines, potentially impacting market dynamics[1][3].

Key Takeaways

  • Clinical Equivalence: The DCP trial has shown that HCTZ and CTD are equally effective in preventing cardiovascular outcomes among elderly veterans with hypertension.
  • Market Growth: The global Hydrochlorothiazide market is projected to grow significantly from 2024 to 2030, driven by increasing demand and expanding healthcare infrastructure.
  • Regional Dynamics: North America, Europe, and the Asia-Pacific region are expected to be key growth areas.
  • Side Effects and Compliance: Despite its effectiveness, HCTZ's use is limited by potential side effects and the need for patient compliance.

FAQs

What is Hydrochlorothiazide used for?

Hydrochlorothiazide (HCTZ) is primarily used to treat hypertension, edema, and kidney calculi. It can also be used to manage diabetes insipidus[4].

What are the key findings of the Diuretic Comparison Project (DCP) trial?

The DCP trial found no significant difference in cardiovascular outcomes between HCTZ and chlorthalidone among elderly veterans with hypertension. However, patients with prior myocardial infarction or stroke showed a potential benefit with chlorthalidone[3].

What are the projected growth rates for the global Hydrochlorothiazide market?

The global Hydrochlorothiazide market is expected to grow at a Compound Annual Growth Rate (CAGR) from 2024 to 2030, driven by increasing demand and expanding healthcare infrastructure[2][5].

Who are the key manufacturers in the Hydrochlorothiazide market?

Key manufacturers include Polpharma API, LGM Pharma, Octavius Pharma, Cambrex, and Changzhou Pharmaceutical Factory[2].

What are the common side effects of Hydrochlorothiazide?

Common side effects include hypokalemia, low blood pressure, and electrolyte imbalances. It should be used with caution in patients with severe kidney disease[4].

How does Hydrochlorothiazide work?

HCTZ works by inhibiting the sodium-chloride cotransporter in the distal convoluted tubule of the kidney, leading to increased excretion of water and electrolytes, which reduces blood pressure and edema[4].

Sources

  1. VA's new "burden-free" study method finds two blood pressure drugs equally effective. Research.va.gov.
  2. Global Hydrochlorothiazide Market Insights, Forecast to 2030. Qyresearch.com.
  3. Diuretic Comparison Project - DCP. American College of Cardiology.
  4. Hydrochlorothiazide - Drug Targets, Indications, Patents. Synapse.patsnap.com.
  5. Hydrochlorothiazide Market To See Incredible Growth During 2021–2030. Einpresswire.com.

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