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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR SIMVASTATIN


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505(b)(2) Clinical Trials for Simvastatin

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 NCT01953835 ↗ A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 Completed GlaxoSmithKline Phase 1 2013-10-04 This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2586184. Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3 subjects to each treatment sequence). Each subject will receive a single dose of the standard formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once with food and once in a fasted state, according to their treatment sequence, with a 3-day wash out between doses. The primary aim of the study is to investigate the effects of GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with and without food on a new formulation of GSK2586184 tablet.
OTC NCT04973800 ↗ Simvastatin and Emotional Processing (OxSTEP) Recruiting Wellcome Trust N/A 2021-06-21 Simvastatin is being employed because it is a 'statin'. As a drug class, statins have broad anti-inflammatory properties. Low-level inflammation is thought to be a potentially important mediator of the effects of psychosocial stress (including loneliness) on affect and vulnerability to depression. In this study we are using statins as an experimental tool to investigate this relationship further. Statins are widely prescribed agents that are regarded as very safe and so are suitable tools in this context. We have selected simvastatin because it is one of the most widely used statins and has an excellent safety profile, being also available 'over the counter'.
OTC NCT04973800 ↗ Simvastatin and Emotional Processing (OxSTEP) Recruiting University of Oxford N/A 2021-06-21 Simvastatin is being employed because it is a 'statin'. As a drug class, statins have broad anti-inflammatory properties. Low-level inflammation is thought to be a potentially important mediator of the effects of psychosocial stress (including loneliness) on affect and vulnerability to depression. In this study we are using statins as an experimental tool to investigate this relationship further. Statins are widely prescribed agents that are regarded as very safe and so are suitable tools in this context. We have selected simvastatin because it is one of the most widely used statins and has an excellent safety profile, being also available 'over the counter'.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Simvastatin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000553 ↗ HDL-Atherosclerosis Treatment Study (HATS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1994-09-01 To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (HDL) cholesterol.
NCT00000553 ↗ HDL-Atherosclerosis Treatment Study (HATS) Completed University of Washington Phase 3 1994-09-01 To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (HDL) cholesterol.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed Centers for Disease Control and Prevention Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Eye Institute (NEI) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗ Action to Control Cardiovascular Risk in Diabetes (ACCORD) Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1999-09-01 The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Simvastatin

Condition Name

Condition Name for Simvastatin
Intervention Trials
Hypercholesterolemia 91
Dyslipidemia 26
Atherosclerosis 23
Healthy 19
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Condition MeSH

Condition MeSH for Simvastatin
Intervention Trials
Hypercholesterolemia 105
Dyslipidemias 53
Coronary Artery Disease 36
Diabetes Mellitus 36
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Clinical Trial Locations for Simvastatin

Trials by Country

Trials by Country for Simvastatin
Location Trials
United States 683
Canada 69
United Kingdom 40
Spain 37
Korea, Republic of 30
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Trials by US State

Trials by US State for Simvastatin
Location Trials
California 45
Texas 39
Florida 35
New York 33
Pennsylvania 29
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Clinical Trial Progress for Simvastatin

Clinical Trial Phase

Clinical Trial Phase for Simvastatin
Clinical Trial Phase Trials
Phase 4 131
Phase 3 139
Phase 2/Phase 3 19
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Clinical Trial Status

Clinical Trial Status for Simvastatin
Clinical Trial Phase Trials
Completed 369
Unknown status 63
Terminated 44
[disabled in preview] 58
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Clinical Trial Sponsors for Simvastatin

Sponsor Name

Sponsor Name for Simvastatin
Sponsor Trials
Merck Sharp & Dohme Corp. 93
AstraZeneca 16
National Heart, Lung, and Blood Institute (NHLBI) 14
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Sponsor Type

Sponsor Type for Simvastatin
Sponsor Trials
Other 566
Industry 264
NIH 43
[disabled in preview] 22
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