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Completed

NCT Number: NCT00418834

Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in combination and two higher doses of atorvastatin on lipid lowering.

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Key information

Conditions

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

Age range

65 year and older

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

  • Patient is age 65 or older
  • Patient is willing to maintain cholesterol lowering diet
  • Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending on their CHD risk category

Exclusion criteria

  • A condition which, in the opinion of the investigator, would pose a risk to the patient or interfere with participation in the study
  • Patient is unlikely to be compliant in taking study medication
  • Patient with chronic or unstable medical condition
  • Patient is taking unstable doses of medication
  • Patient drinks more than 2 alcoholic drinks per day
  • Patient has elevations in certain laboratory values (CK, AST, ALT)

Treatment and study plan

ezetimibe and atorvastatin

Drug

ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks

atorvastatin

Drug

Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks

Placebo (unspecified)

Drug

Placebo (unspecified) daily for 12 weeks

Primary outcomes

  1. Percent Change From Baseline in LDL-C at Week 6

    Time frame: Baseline and Week 6

Secondary outcomes

  1. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline and Week 12

  2. Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6

    Time frame: Week 6

  3. Number of Patients Who Achieved Low Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 12

    Time frame: Week 12

  4. Number of Patients Who Achieved LDL-C <100 mg/dL for Patients Without Atherosclerotic Vascular Disease (AVD) and LDL-C <70 mg/dL for Patients With Atherosclerotic Vascular Disease (AVD) at Week 6

    Time frame: Week 6

  5. Number of Patients Who Achieved LDL-C<100 mg/dL for Patients Without AVD and LDL-C<70 mg/dL for Patients With AVD at Week 12

    Time frame: Week 12

Other outcomes

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

    Time frame: Baseline and Week 6

  2. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 6

  4. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: Baseine and Week 12

  5. Percent Change From Baseline in Total Cholesterol (TC) at Week 6

    Time frame: Baseline and Week 6

  6. Percent Change From Baseline in Total Cholesterol (TC) at Week 12

    Time frame: Baseline and Week 12

  7. Percent Change From Baseline in Triglycerides (TG) at Week 6

    Time frame: Baseline and Week 6

  8. Percent Change From Baseline in Triglycerides (TG) at Week 12

    Time frame: Baseline and Week 12

  9. Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 6

    Time frame: Baseline and Week 6

  10. Percent Change From Baseline in Apo Lipoprotein B (Apo B) at Week 12

    Time frame: Baseline and Week 12

  11. Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 6

    Time frame: Baseline and Week 6

  12. Percent Change From Baseline in Apo Lipoprotein A-I (Apo A-I) at Week 12

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 6

  14. Percent Change From Baseline in Total Cholesterol (TC):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 6

  16. Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

    Time frame: Baseline and Week 12

  17. Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 6

    Time frame: Baseline and Week 6

  18. Percent Change From Baseline in Apo Lipoprotein B (Apo B):Apo Lipoprotein A-I (Apo A-I) Ratio at Week 12

    Time frame: Baseline and Week 12

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

    Time frame: Baseline and Week 6

  20. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 12

    Time frame: Baseline and Week 12

  21. Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 6

    Time frame: Baseline and Week 6

  22. Percent Change From Baseline in Ratio of Highly Selective C-Reactive Protein (Hs-CRP) at Week 12

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel Arm, 12-Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Elderly Patients With Hypercholesterolemia at High Risk for CHD

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 5, 2007
Registry last updated
May 14, 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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