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Completed

NCT Number: NCT00409773

Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)

A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemias Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Metabolic Syndrome 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

  • Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL depending on their CHD risk category

Exclusion criteria

  • A condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study
  • Patient is likely to be greater than 20% noncompliant in taking study medications
  • Patients with chronic medical conditions
  • Patients with unstable doses of medications
  • Pregnant or lactating women, women intending to become pregnant
  • Patient is currently receiving prescription therapy with statins or other lipid-altering medications
  • Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)

Treatment and study plan

ezetimibe (+) simvastatin

Drug

Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.

Other names: MK0653A, Vytorin®

Comparator: atorvastatin calcium

Drug

Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.

Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Other names: Lipitor ®

Comparator: Placebo (Unspecified)

Drug

Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.

ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.

Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.

Primary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

Secondary outcomes

  1. Percent Change From Baseline in Total Cholesterol(mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

  2. Percent Change From Baseline in Triglyceride (TG) (mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

  3. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  4. Percent Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  5. Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  6. Percent Change From Baseline in Apolipoprotein- B (Apo-B) at Week 6

    Time frame: Baseline and 6 Weeks

  7. Percent Change From Baseline in Apolipoprotein-A1 (Apo-A1) at Week 6

    Time frame: Baseline and 6 Weeks

  8. Percent Change From Baseline in Total-Cholesterol: High Density Lipoprotein-Cholesterol (Total-C:HDL- C) at Week 6

    Time frame: Baseline and 6 Weeks

  9. Percent Change From Baseline in Low Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (LDL-C: HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  10. Percent Change From Baseline in Apolipoprotein-B: Apolipoprotein-A1 (Apo-B:Apo-A1) at Week 6

    Time frame: Baseline and 6 weeks

  11. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol: High Density Lipoprotein Cholesterol (Non-HDL-C:HDL-C) at Week 6

    Time frame: Baseline and 6 Weeks

  12. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients With Atherosclerotic Vascular Disease (AVD)

    Time frame: Baseline and 6 Weeks

  13. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 6 in Patients Without Atherosclerotic Vascular Disease (AVD)

    Time frame: Baseline and 6 Weeks

  14. Percent Change From Baseline in High-Sensitivity C-reactive (Hs-CRP) (mg/dL) at Week 6

    Time frame: Baseline and 6 Weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel Arm, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Versus Atorvastatin in Patients With Metabolic Syndrome and Hypercholesterolemia at High Risk for Coronary Heart Disease

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 11, 2006
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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