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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR TEVETEN HCT


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505(b)(2) Clinical Trials for TEVETEN HCT

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 Formulation NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed author! et al. BV Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Quintiles, Inc. Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Synexus Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
New Formulation NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Abbott Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for TEVETEN HCT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01087749 ↗ Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers Completed University of California, San Francisco Phase 1 2010-03-01 The purpose of this study is to find out how chemicals in the blood of patients with chronic kidney disease affect how medications are removed from the body. The patient will take one dose of three different drugs, one on each week, for a total of three single doses. The investigators want to find out if these three different medications are affected in different ways by the chemicals in the blood of patients with kidney disease.
NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed author! et al. BV Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Quintiles, Inc. Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Synexus Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT01631227 ↗ Comparison of the Effect of Eprosartan and Eprosartan Mesylate on Blood Pressure in Essential Hypertension Completed Abbott Phase 3 2012-06-01 Aim of this study is to compare the blood pressure lowering effect of a new drug formulation of eprosartan. Eprosartan belongs to a class of blood pressure lowering agents used worldwide since years with proven efficacy. The new formulation is compared to the currently marketed eprosartan tablet. Equivalent efficacy in blood pressure lowering effects should be demonstrated.
NCT04954560 ↗ Effect of Losartan or Eprosartan on Fructose Hyperuricemia Completed Medical University of Lodz N/A 2008-01-01 Hyperuricemia is seen in about 20% of adults in the general population, Chronic hyperuricemia, frequently manifesting as the gout, is a well-known risk factor of joint damage but has been also linked to a variety of other pathologies mostly affecting the cardiovascular system. The close relation between high uric acid concentration and increased risk of cardiovascular disease has been reported for more than a century. Furthermore, many studies reported a strong association between hyperuricemia, arterial hypertension, obesity and cardiovascular diseases even in an absence of typical clinical manifestations of gout. Several studies showed that the prevalence of hyperuricemia in patients with hypertension is much higher than in the general population and may worsen after the onset of antihypertensive treatment. That may indicate that hyperuricemia may be also caused by antihypertensive drugs. In contrast to diuretics and nonselective beta blockers the agents that block the renin-angiotensin-aldosterone system have had a neutral effect on serum uric acid. Several clinical studies showed that losartan in contrast to other AT1-receptor agonists, may have specific uricosuric properties and thereby can lower uric acid concentration. It has been speculated that uricosuric effect could make losartan particularly useful for the treatment of arterial hypertension associated with hyperuricemia and metabolic syndrome. The uricosuric effect of losartan is most likely due to overlapping two different mechanisms regulating the excretion of uric acid. Losartan may increase uric acid tubular secretion in the same way as other inhibitors of the renin-angiotensin-aldosterone system, but in addition it may specifically inhibit post-secretory resorption of uric acid in the proximal tubule. The effect may be due to a specific structure of the losartan molecule. The urateanion transporter is a monoammonium selective transporter, and the losartan molecule is mainly a monoanion at normal pH range (as opposed to dianion e.g. eprosartan) and therefore is a good substrate for the exchanger. However, this concept remains speculative since, e.g. irbesartan which is also a monoanion has no consistent uricosuric effect. Fructose, in contrast to other carbohydrates causes an increase of serum uric acid concentration, which may facilitate the development of the metabolic syndrome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TEVETEN HCT

Condition Name

Condition Name for TEVETEN HCT
Intervention Trials
Essential Hypertension 1
Kidney Disease 1
Uric Acid Concentration, Serum, Quantitative Trait Locus 7 1
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Condition MeSH

Condition MeSH for TEVETEN HCT
Intervention Trials
Renal Insufficiency, Chronic 1
Kidney Diseases 1
Metabolic Syndrome 1
Hypertension 1
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Clinical Trial Locations for TEVETEN HCT

Trials by Country

Trials by Country for TEVETEN HCT
Location Trials
United States 1
United Kingdom 1
Russian Federation 1
Germany 1
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Trials by US State

Trials by US State for TEVETEN HCT
Location Trials
California 1
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Clinical Trial Progress for TEVETEN HCT

Clinical Trial Phase

Clinical Trial Phase for TEVETEN HCT
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for TEVETEN HCT
Clinical Trial Phase Trials
Completed 3
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Clinical Trial Sponsors for TEVETEN HCT

Sponsor Name

Sponsor Name for TEVETEN HCT
Sponsor Trials
University of California, San Francisco 1
author! et al. BV 1
Quintiles, Inc. 1
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Sponsor Type

Sponsor Type for TEVETEN HCT
Sponsor Trials
Other 4
Industry 2
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