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Last Updated: December 12, 2019

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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 2013-10-01 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.
>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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Simvastatin

Condition Name

Condition Name for Simvastatin
Intervention Trials
Hypercholesterolemia 83
Dyslipidemia 25
Atherosclerosis 21
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Condition MeSH

Condition MeSH for Simvastatin
Intervention Trials
Hypercholesterolemia 98
Dyslipidemias 46
Coronary Artery Disease 35
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Clinical Trial Locations for Simvastatin

Trials by Country

Trials by Country for Simvastatin
Location Trials
United States 582
Canada 54
United Kingdom 34
Korea, Republic of 30
Spain 26
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Trials by US State

Trials by US State for Simvastatin
Location Trials
California 37
Texas 33
Florida 30
New York 28
Maryland 26
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Clinical Trial Progress for Simvastatin

Clinical Trial Phase

Clinical Trial Phase for Simvastatin
Clinical Trial Phase Trials
Phase 4 112
Phase 3 130
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Simvastatin
Clinical Trial Phase Trials
Completed 291
Recruiting 59
Unknown status 52
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Clinical Trial Sponsors for Simvastatin

Sponsor Name

Sponsor Name for Simvastatin
Sponsor Trials
Merck Sharp & Dohme Corp. 90
AstraZeneca 14
GlaxoSmithKline 11
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Sponsor Type

Sponsor Type for Simvastatin
Sponsor Trials
Other 434
Industry 232
NIH 36
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