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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00479713
First received: May 24, 2007
Last updated: October 10, 2013
Last verified: October 2013
  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 Sharp & Dohme Corp.:

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.



Other Outcome Measures:
  • Percent Change From Baseline in Total Cholesterol [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in Triglycerides. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in Apolipoprotein B [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.

  • Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure *100.


Enrollment: 618
Study Start Date: February 2007
Study Completion Date: March 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:
  • MK0653A
  • Vytorin®
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479713

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00479713     History of Changes
Other Study ID Numbers: 0653A-809, 2007_552
Study First Received: May 24, 2007
Results First Received: February 11, 2009
Last Updated: October 10, 2013
Health Authority: France: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
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 April 16, 2014