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OpenTrials
Completed

NCT Number: NCT00276484

To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 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 >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion criteria

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin

Treatment and study plan

atorvastatin

Drug

Atorvastatin 80 mg tablet by mouth, once a day for 6 weeks

ezetimibe

Drug

Ezetimibe 10 mg tablets by mouth, once a day for 6 weeks.

Primary outcomes

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

    Time frame: Baseline and 6 weeks

    Percent Change in LDL-C = [(week 6 value - baseline value)/baseline value]*100%

Secondary outcomes

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

    Time frame: Baseline and 6 weeks

    Percent Change in HDL-C = [(week 6 value - baseline value)/baseline value]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in Non-HDL-C = [(week 6 value - baseline value)/baseline value]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in Total-C = [(week 6 value - baseline value)/baseline value]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in TG = [(week 6 value - baseline value)/baseline value]*100%

  5. Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)

    Time frame: Baseline and 6 Weeks

    Percent Change in Apo B = [(week 6 value - baseline value)/baseline value]*100%

  6. Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)

    Time frame: Baseline and 6 Weeks

    Percent Change in Apo A-I = [(week 6 value - baseline value)/baseline value]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in TC:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in LDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  9. Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio

    Time frame: Baseline and 6 Weeks

    Percent Change in Apo B:Apo A-I Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

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

    Time frame: Baseline and 6 Weeks

    Percent Change in non-HDL-C:HDL-C Ratio = [(week 6 ratio - baseline ratio)/baseline ratio]*100%

  11. Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)

    Time frame: Baseline and 6 Weeks

    Percent Change in CRP = [(week 6 value - baseline value)/baseline value]*100%

  12. Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 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 High Risk for CHD Not Adequately Controlled on Atorvastatin 40 Mg

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2006
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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