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Last Updated: August 7, 2020

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CLINICAL TRIALS PROFILE FOR ANGIOTENSIN II

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505(b)(2) Clinical Trials for Angiotensin Ii

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 NCT01053936 Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease Completed Reata Pharmaceuticals, Inc. Phase 2 2010-01-01 This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
OTC NCT04397445 Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration Not yet recruiting Spaulding Clinical Research LLC Phase 1 2020-06-01 Ranitidine is an over-the-counter and prescription drug, which decreases the amount of acid secreted by the stomach. Some ranitidine medicines contain an impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. The US Food and Drug Administration (FDA) has found levels of NDMA in some ranitidine products similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. The ranitidine that will be used in this study has been tested twice (months apart) and shown to have stable NDMA levels well below the acceptable daily limit. Of note, the risk of NDMA with ranitidine is only relevant with prolonged chronic administration as at the acceptable limit, there is approximately a 1 in 100,000 chance of cancer after 70 years of exposure to that level. FDA has also conducted tests that simulate the potential formation of NDMA from ranitidine after it has been exposed to acid in the stomach with a normal diet. Results of these tests indicate that NDMA is not formed in typical stomach conditions. Similarly, if ranitidine is exposed to a simulated small intestinal fluid, NDMA is not formed. Other laboratory experiments suggest a combination of nitrites, such as found in processed meats, and an acidic environment may increase NDMA formation, however the levels of nitrites tested were very high. Separately, a previous study in 10 healthy volunteers showed that volunteers who received ranitidine had an increase in urinary NDMA excreted over 24 h. The level of increase was greater than would be expected from laboratory testing. This clinical study is being performed to determine if and how much NDMA is produced from ranitidine in the human body and whether nitrite-containing foods may increase formation of NDMA. The study will use a prescription dose of ranitidine (300 mg) to test whether there is increased urinary NDMA excretion levels over 24-hours after ranitidine administration in comparison to placebo when participants are administered low nitrite/NDMA meals and when subjects are administered high nitrite/NDMA meals. On 4 different days, each participant will receive ranitidine or placebo with high nitrite/NDMA meals and ranitidine or placebo with low nitrite/NDMA meals.
OTC NCT04397445 Clinical Study to Investigate the Urinary Excretion of N-nitrosodimethylamine (NDMA) After Ranitidine Administration Not yet recruiting Food and Drug Administration (FDA) Phase 1 2020-06-01 Ranitidine is an over-the-counter and prescription drug, which decreases the amount of acid secreted by the stomach. Some ranitidine medicines contain an impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. The US Food and Drug Administration (FDA) has found levels of NDMA in some ranitidine products similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats. The ranitidine that will be used in this study has been tested twice (months apart) and shown to have stable NDMA levels well below the acceptable daily limit. Of note, the risk of NDMA with ranitidine is only relevant with prolonged chronic administration as at the acceptable limit, there is approximately a 1 in 100,000 chance of cancer after 70 years of exposure to that level. FDA has also conducted tests that simulate the potential formation of NDMA from ranitidine after it has been exposed to acid in the stomach with a normal diet. Results of these tests indicate that NDMA is not formed in typical stomach conditions. Similarly, if ranitidine is exposed to a simulated small intestinal fluid, NDMA is not formed. Other laboratory experiments suggest a combination of nitrites, such as found in processed meats, and an acidic environment may increase NDMA formation, however the levels of nitrites tested were very high. Separately, a previous study in 10 healthy volunteers showed that volunteers who received ranitidine had an increase in urinary NDMA excreted over 24 h. The level of increase was greater than would be expected from laboratory testing. This clinical study is being performed to determine if and how much NDMA is produced from ranitidine in the human body and whether nitrite-containing foods may increase formation of NDMA. The study will use a prescription dose of ranitidine (300 mg) to test whether there is increased urinary NDMA excretion levels over 24-hours after ranitidine administration in comparison to placebo when participants are administered low nitrite/NDMA meals and when subjects are administered high nitrite/NDMA meals. On 4 different days, each participant will receive ranitidine or placebo with high nitrite/NDMA meals and ranitidine or placebo with low nitrite/NDMA meals.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Angiotensin Ii

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000516 Studies of Left Ventricular Dysfunction (SOLVD) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1985-07-01 To determine if enalapril treatment of left ventricular dysfunction (LVD) due to ischemic or hypertensive heart disease led to reduced mortality and morbidity in symptomatic and asymptomatic patients. There were a Prevention Trial, a Treatment Trial, and a registry.
NCT00000522 Treatment of Mild Hypertension Study (TOMHS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1985-08-01 To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 Treatment of Mild Hypertension Study (TOMHS) Completed University of Minnesota - Clinical and Translational Science Institute Phase 2 1985-08-01 To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000531 Antiarrhythmics Versus Implantable Defibrillators (AVID) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1992-09-01 To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from arrhythmic causes.
NCT00000542 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-08-01 To determine if the combined incidence of nonfatal myocardial infarction and coronary heart disease death differs between diuretic-based and each of three alternative antihypertensive pharmacological treatments. Also, to determine, in a subset of this population, if lowering serum cholesterol with a HMG CoA reductase inhibitor in older adults reduces all-cause mortality compared to a control group receiving usual care. Conducted in conjunction with the Department of Veterans' Affairs.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Angiotensin Ii

Condition Name

Condition Name for Angiotensin Ii
Intervention Trials
Hypertension 217
Heart Failure 51
Diabetic Nephropathy 43
Chronic Kidney Disease 36
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Condition MeSH

Condition MeSH for Angiotensin Ii
Intervention Trials
Hypertension 218
Kidney Diseases 156
Heart Failure 100
Diabetes Mellitus 98
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Clinical Trial Locations for Angiotensin Ii

Trials by Country

Trials by Country for Angiotensin Ii
Location Trials
Italy 148
Canada 139
Germany 116
China 67
Mexico 65
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Trials by US State

Trials by US State for Angiotensin Ii
Location Trials
Texas 76
California 75
New York 70
Ohio 66
Florida 65
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Clinical Trial Progress for Angiotensin Ii

Clinical Trial Phase

Clinical Trial Phase for Angiotensin Ii
Clinical Trial Phase Trials
Phase 4 324
Phase 3 194
Phase 2/Phase 3 32
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Clinical Trial Status

Clinical Trial Status for Angiotensin Ii
Clinical Trial Phase Trials
Completed 465
Recruiting 179
Not yet recruiting 137
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Clinical Trial Sponsors for Angiotensin Ii

Sponsor Name

Sponsor Name for Angiotensin Ii
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 46
Takeda 32
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 25
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Sponsor Type

Sponsor Type for Angiotensin Ii
Sponsor Trials
Other 1183
Industry 324
NIH 104
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