Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00166504
First received: September 9, 2005
Last updated: January 14, 2015
Last verified: January 2015
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Purpose
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe (+) simvastatin Drug: atorvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Patients With Primary Hypercholesterolemia |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- LDL-C Lowering Efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]LDL-C = low density lipoprotein cholesterol, measured in mg/dl.
| Enrollment: | 203 |
| Study Start Date: | October 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vytorin
Ezetimibe 10 mg/Simvastatin 20 mg
|
Drug: ezetimibe (+) simvastatin
simvastatin/ezetimibe 10/20 mg
Other Names:
|
|
Active Comparator: Atorvastatin
Atorvastatin 10 mg
|
Drug: atorvastatin
atorvastatin 10 mg
Other Name: Lipitor®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of hypercholesterolemia
- LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL
- National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III guideline
Exclusion Criteria:
- Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase) inhibitors or Ezetimibe
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00166504
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166504
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
No publications provided
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00166504 History of Changes |
| Other Study ID Numbers: | 0653A-092, MK0653A-092, 2005_070 |
| Study First Received: | September 9, 2005 |
| Results First Received: | October 13, 2008 |
| Last Updated: | January 14, 2015 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Ezetimibe Simvastatin Anticholesteremic Agents |
Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015