Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00462748 |
To evaluate the percentage of patients with either established Cardio Vascular 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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicentre, Double-Blind, Randomised, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Ezetimibe/Simvastatin 10/40mg, Atorvastatin 40mg, and Rosuvastatin 10mg to Achieve an LDL-C Level of <2mmol/l in Patients With Established CVD or at "High Risk" of Developing CVD, Currently Treated With Simvastatin 40mg and With a Fasting LDL-C 2 Mmol/l |
Enrollment: | 800 |
Study Start Date: | March 2007 |
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.
|
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 10mg. once daily tablet formulation, All tablet form, taken orally.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00462748 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Rosuvastatin Metabolic Diseases Hyperlipidemias Simvastatin Ezetimibe |
Metabolic disorder Hypercholesterolemia Atorvastatin Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |