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Last Updated: January 27, 2023

CLINICAL TRIALS PROFILE FOR ATORVASTATIN CALCIUM


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505(b)(2) Clinical Trials for Atorvastatin Calcium

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
OTC NCT01964326 ↗ Actual Use Trial of Atorvastatin Calcium 10 mg Completed Pfizer Phase 3 2013-10-01 The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
OTC NCT01964326 ↗ Actual Use Trial of Atorvastatin Calcium 10 mg Completed Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Phase 3 2013-10-01 The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Atorvastatin Calcium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000941 ↗ A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
NCT00017758 ↗ The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.
NCT00024531 ↗ Lipitor as a Treatment for Alzheimer's Disease Completed Pfizer Phase 2 2000-10-01 The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00024531 ↗ Lipitor as a Treatment for Alzheimer's Disease Completed Institute for the Study of Aging (ISOA) Phase 2 2000-10-01 The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00065806 ↗ Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) Completed Laura Schanberg Phase 3 2003-09-01 The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin. 3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively. 4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
NCT00211939 ↗ CARE-2 (Calcium Acetate [PhosLo┬«]/Sevelamer[Renagel┬«] Evaluation Study 2) for Heart Calcification in Dialysis Patients Completed Nabi Biopharmaceuticals Phase 4 2005-01-01 The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Atorvastatin Calcium

Condition Name

Condition Name for Atorvastatin Calcium
Intervention Trials
Healthy 10
Hypercholesterolemia 7
Dyslipidemias 4
Dyslipidemia 3
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Condition MeSH

Condition MeSH for Atorvastatin Calcium
Intervention Trials
Dyslipidemias 9
Hypercholesterolemia 7
Heart Diseases 5
Myocardial Ischemia 4
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Clinical Trial Locations for Atorvastatin Calcium

Trials by Country

Trials by Country for Atorvastatin Calcium
Location Trials
United States 65
China 13
India 5
Korea, Republic of 3
Egypt 3
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Trials by US State

Trials by US State for Atorvastatin Calcium
Location Trials
Maryland 6
Washington 5
Minnesota 5
California 5
Colorado 4
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Clinical Trial Progress for Atorvastatin Calcium

Clinical Trial Phase

Clinical Trial Phase for Atorvastatin Calcium
Clinical Trial Phase Trials
Phase 4 11
Phase 3 12
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Atorvastatin Calcium
Clinical Trial Phase Trials
Completed 46
Not yet recruiting 5
Unknown status 5
[disabled in preview] 8
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Clinical Trial Sponsors for Atorvastatin Calcium

Sponsor Name

Sponsor Name for Atorvastatin Calcium
Sponsor Trials
National Cancer Institute (NCI) 7
Pfizer 6
Dr. Reddy's Laboratories Limited 6
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Sponsor Type

Sponsor Type for Atorvastatin Calcium
Sponsor Trials
Other 52
Industry 34
NIH 12
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