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Completed

NCT Number: NCT00276458

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

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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

  • Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg

Exclusion criteria

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin
  • Patient with diabetes or coronary heart disease

Treatment and study plan

Comparator: atorvastatin

Drug

Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks

Comparator: placebo

Drug

Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks

Comparator: ezetimibe

Drug

Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.

Comparator: Placebo.

Drug

Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Primary outcomes

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

    Time frame: 6 weeks

    [(6 week value - baseline value)/baseline value]*100%.

Secondary outcomes

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

    Time frame: 6 weeks

    [(6 week value - baseline value)/baseline value]*100%.

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

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

  3. Percent Change From Baseline in Total-Cholesterol at Week 6

    Time frame: 6 Weeks

    ([6 week value - baseline value)/baseline value]*100%.

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

    Time frame: 6 weeks

    [(6 week value - baseline value)/baseline value]*100%.

  5. Percent Change From Baseline in Apolipoprotein B at Week 6

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

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

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

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

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

  8. Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

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

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

  10. Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6

    Time frame: 6 Weeks

    [(6 week value - baseline value)/baseline value]*100%.

  11. Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter., Rand., Double-Blind, Titration Study to Evaluate & Compare the Efficacy & Safety of Ezetimibe Plus Atorvastatin Vs Atorvastatin in Hypercholesterolemic Pts. at Moderately High Risk for CHD Not Adequately Controlled on Atorvastatin 20 Mg

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2006
Registry last updated
May 13, 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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