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Last Updated: February 25, 2021

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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 Not yet recruiting Hospices Civils de Lyon Phase 3 2021-01-01 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, we hypothesize that fluconazole is effective to decrease and normalize calciuria in patients with hypercalciuria and increased 1,25(OH)2D levels. Our 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, we 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) N/A 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).
NCT00005520 Genetic Epidemiology of Responses to Antihypertensives Completed Mayo Clinic N/A 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).
NCT00007592 Hypertension Screening and Treatment Program Completed VA Office of Research and Development N/A 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.
NCT00089713 Systolic Pressure Efficacy and Safety Trial of Alagebrium (SPECTRA) Terminated Synvista Therapeutics, Inc Phase 2 2004-03-01 This study comprises a 3- to 6-week hydrochlorothiazide run in phase, followed by a 12 week double-blind treatment phase, followed by a 2 week single-blind follow-up hydrochlorothiazide treatment phase. The combined total duration of patient participation is approximately 17-20 weeks. Four double-blind treatment groups approximately equal in size (98) will comprise the study population: placebo or various alagebrium dose groups (10, 50, or 150 mg/day).
NCT00095394 Irbesartan/Hydrochlorothiazide (HCTZ) Combination Therapy as First Line Treatment for Severe Hypertension Completed Sanofi Phase 3 2004-09-01 The purpose of this clinical research is to learn if severe hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hydrochlorothiazide

Condition Name

Condition Name for Hydrochlorothiazide
Intervention Trials
Hypertension 203
Healthy 35
Essential Hypertension 28
Diabetes Mellitus, Type 2 7
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Condition MeSH

Condition MeSH for Hydrochlorothiazide
Intervention Trials
Hypertension 210
Diabetes Mellitus 18
Diabetes Mellitus, Type 2 14
Cardiovascular Diseases 7
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Clinical Trial Locations for Hydrochlorothiazide

Trials by Country

Trials by Country for Hydrochlorothiazide
Location Trials
United States 615
Germany 56
Japan 40
Canada 40
Netherlands 22
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Trials by US State

Trials by US State for Hydrochlorothiazide
Location Trials
New Jersey 30
Texas 30
Florida 27
California 27
North Carolina 22
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Clinical Trial Progress for Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Hydrochlorothiazide
Clinical Trial Phase Trials
Phase 4 117
Phase 3 96
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Hydrochlorothiazide
Clinical Trial Phase Trials
Completed 255
Recruiting 27
Not yet recruiting 23
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Clinical Trial Sponsors for Hydrochlorothiazide

Sponsor Name

Sponsor Name for Hydrochlorothiazide
Sponsor Trials
Novartis 48
Boehringer Ingelheim 36
Merck Sharp & Dohme Corp. 17
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Sponsor Type

Sponsor Type for Hydrochlorothiazide
Sponsor Trials
Industry 247
Other 191
NIH 10
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