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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00462748 |
Purpose
To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe (+) simvastatin Drug: Comparator: atorvastatin Drug: Comparator: rosuvastatin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40mg, Atorva 40mg, Rosuva 10mg in Achieving LDL-C <2mmol/l in Pts With CVD...on Simva 40mg With LDL-C ³2 Mmol/l |
| Enrollment: | 786 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Arm 1: Drug
|
Drug: ezetimibe (+) simvastatin
ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.
|
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2: Active Comparator
Arm 2: Active comparator
|
Drug: Comparator: atorvastatin
atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
|
|
3: Active Comparator
Arm 3: Active comparator
|
Drug: Comparator: rosuvastatin
rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_013, MK0653A-121 |
| Study First Received: | April 18, 2007 |
| Results First Received: | May 7, 2009 |
| Last Updated: | July 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00462748 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Antilipemic Agents Enzyme Inhibitors Ezetimibe Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Rosuvastatin Therapeutic Uses Hypercholesterolemia Dyslipidemias Atorvastatin Lipid Metabolism Disorders |