CLINICAL TRIALS PROFILE FOR SIMVASTATIN
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505(b)(2) Clinical Trials for Simvastatin
| 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 | >Sponsor | >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. |
| NCT00000620 ↗ | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | Completed | National Institute on Aging (NIA) | 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 | >Sponsor | >Phase | >Start Date | >Summary |
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