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 is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol...
Brief Summary
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”
This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: ezetimibe (+) simvastatin
- ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.
- Drug: Comparator : rosuvastatin calcium
- rosuvastatin 10mg. The treatment duration will be 6 weeks.
- Drug: Comparator: Placebo (unspecified)
- rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.
- Drug: Comparator: Placebo (unspecified)
- ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 6 weeks.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Arm 1: drug
- Active Comparator: 2
- Arm 2: active comparator
Outcome Measures for this Clinical Trial
Primary Measures
- Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
- Time Frame: Baseline and 6 weeks
Safety Issue?: No
- Time Frame: Baseline and 6 weeks
Secondary 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
Safety Issue?: No
- Time Frame: after 6 weeks of treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 79 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Farnier M, Averna M, Missault L, Vaverkova H, Viigimaa M, Massaad R, Vandormael K, Johnson-Levonas AO, Brudi P. Lipid-altering efficacy of ezetimibe/simvastatin 10/20 mg compared with rosuvastatin 10 mg in high-risk hypercholesterolaemic patients inadequately controlled with prior statin monotherapy - The IN-CROSS study. Int J Clin Pract. 2009 Apr;63(4):547-59. Epub 2009 Feb 16.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00479713
Study ID Number: 2007_552
ClinicalTrials.gov Identifier: NCT00479713
Health Authority: France: Ministry of Health
(MedWatch - FDA maintained medical product safety Information)
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00479713
