A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00479713
First received: May 24, 2007
Last updated: September 23, 2010
Last verified: September 2010
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Purpose
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: ezetimibe (+) simvastatin Drug: Comparator : rosuvastatin calcium Drug: Comparator: Placebo (unspecified) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Active-Controlled, Multicenter Study to Assess the LDL-C Lowering of Switching to a Combo Tab Ezetimibe/Simvastatin (10 mg/20 mg) Compared to Rosuvastatin 10 mg in Patients With Primary High Cholesterol and High Cardiovascular Risk Not Controlled With a Prior Statin Treatment |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.
Secondary Outcome Measures:
- The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
The percentage of participants who achieved a target LDL-C goal of < 100 mg/dL, of <70 mg/dL, and of <77 mg/dL at study endpoint after six weeks of treatment.
The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.
| Enrollment: | 618 |
| Study Start Date: | March 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: drug
|
Drug: ezetimibe (+) simvastatin
ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
Other Names:
Drug: Comparator: Placebo (unspecified)
rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
|
|
Active Comparator: 2
Arm 2: active comparator
|
Drug: Comparator : rosuvastatin calcium
rosuvastatin 10mg. The treatment duration will be 6 weeks.
Drug: Comparator: Placebo (unspecified)
ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participant is currently taking a statin medication for the treatment of high cholesterol
- Participant has an LDL-C level that is greater than or equal to 100 mg/dl and less than or equal to 190 mg/dl
Exclusion Criteria:
- Women who are pregnant or nursing, or women who intend to become pregnant
- Participant has any condition, situation, or is currently taking any medication that might pose a risk to the participant or interfere with participation in the study
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00479713 History of Changes |
| Other Study ID Numbers: | 2007_552, MK0653A-809 |
| Study First Received: | May 24, 2007 |
| Results First Received: | February 11, 2009 |
| Last Updated: | September 23, 2010 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Merck:
|
High Cholesterol |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Anticholesteremic Agents Simvastatin Rosuvastatin Ezetimibe |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013