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Completed

NCT Number: NCT00479713

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe (+) simvastatin

Drug

ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.

Other names: MK0653A, Vytorin®

Comparator : rosuvastatin calcium

Drug

rosuvastatin 10mg. The treatment duration will be 6 weeks.

Comparator: Placebo (Unspecified)

Drug

rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.

Primary outcomes

  1. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment

    Time frame: Baseline and 6 weeks

    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 outcomes

  1. 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

    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 outcomes

  1. Percent Change From Baseline in Total Cholesterol

    Time frame: Baseline and 6 weeks

    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.

  2. Percent Change From Baseline in Triglycerides.

    Time frame: Baseline and 6 weeks

    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.

  3. Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)

    Time frame: Baseline and 6 weeks

    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.

  4. Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)

    Time frame: Baseline and 6 weeks

    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.

  5. Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio

    Time frame: Baseline and 6 weeks

    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.

  6. Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio

    Time frame: Baseline and 6 weeks

    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.

  7. Percent Change From Baseline in Apolipoprotein B

    Time frame: Baseline and 6 weeks

    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.

  8. Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein

    Time frame: Baseline and 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 28, 2007
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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