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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 27, 2014
Last verified: October 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 27, 2014
Health Authority: France: Ministry of Health

Keywords provided by Merck Sharp & Dohme Corp.:
High Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Ezetimibe
Rosuvastatin
Simvastatin
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014