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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00862251 |
Purpose
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) vs rosuvastatin (10 mg) vs doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disorder Diabetes Mellitus |
Drug: ezetimibe (+) simvastatin Drug: Comparator: simvastatin 40 mg or atorvastatin 20 mg Drug: Comparator: rosuvastatin Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Active-Controlled Study of Patients With Cardiovascular Disease and Diabetes Mellitus Not Adequately Controlled With Simvastatin or Atorvastatin: Comparison of Switching to Combination Tablet Ezetimibe/Simvastatin vs Switching to Rosuvastatin or Doubling the Statin Dose |
| Estimated Enrollment: | 800 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
ezetimibe/simvastatin
|
Drug: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks.
Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg
All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
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|
2: Active Comparator
Doubling statin dose.
|
Drug: Comparator: simvastatin 40 mg or atorvastatin 20 mg
simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg
All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
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3: Active Comparator
rosuvastatin 10 mg tablets
|
Drug: Comparator: rosuvastatin
rosuvastatin 10 mg tablets, taken once daily for six weeks.
Drug: Comparator: atorvastatin 10 mg or simvastatin 20 mg
All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Toll Free Number | 1-888-577-8839 |
Show 33 Study Locations| Study Director: | Medical Monitor | Merck |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2009_559, MK0653A-133 |
| Study First Received: | March 12, 2009 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00862251 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cardiovascular disorder |
|
Antimetabolites Disease Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Ezetimibe |
Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Pathologic Processes Rosuvastatin Therapeutic Uses Cardiovascular Diseases Glucose Metabolism Disorders Atorvastatin |