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CompletedNCT00276484Updated May 14, 2024Results posted

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

A Phase 3 interventional study of atorvastatin and atorvastatin in Hypercholesterolemia, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
579
Allocation
Randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 579 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with LDL-C >70 mg/dL \& on a stable dose of atorvastatin 40 mg

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women or intending to become pregnant
  • Patient with sensitivity or intolerance to ezetimibe or atorvastatin
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
579 participants (actual)

Study arms

  • Active comparator
    1

    Atorvastatin 80 mg

    Drug: atorvastatin

  • Experimental
    2

    Atorvastatin 40 mg + ezetimibe 10 mg

    Drug: atorvastatin · Drug: ezetimibe

Interventions

  • Drugatorvastatin

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

  • Drugatorvastatin

    Atorvastatin 40 mg by mouth, once a day for 6 weeks

  • Drugezetimibe

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline and 6 weeks

Secondary outcomes

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

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

    Time frame: Baseline and 6 weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

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

    Time frame: Baseline and 6 Weeks

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

    Time frame: 6 Weeks

07

Results

Posted Apr 13, 2009

Participant flow

Phase III First Patient In: 4/6/2006; Last Patient Last Visit 2/26/2008 96 centers worldwide (US, Canada) Eligible patients include those on a stable dose of atorvastatin 40 mg; or patients with adjusted LDLC pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.

Participant flow — Overall Study
MilestoneAtorvastatin + EzetemibeAtorvastatin
Started288291
Completed279278
Not completed913
Withdrew: Adverse event47
Withdrew: Lost to follow-up11
Withdrew: Protocol violation01
Withdrew: Withdrawal by subject43
Withdrew: Could not take time off work01

Outcome measures

PrimaryPercent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C

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

Time frame:
Baseline and 6 weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C-27.4 (-29.6 to -25.1)-11.0 (-13.2 to -8.8)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -16.3 · 95% CI -19.4 to -13.2Model terms: treatment and baseline LDL-C value
SecondaryPercent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)

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

Time frame:
Baseline and 6 weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)-0.5 (-1.6 to 0.7)-1.0 (-2.1 to 0.2)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = 0.551 · Mean difference (final values): 0.5 · 95% CI -1.1 to 2.1Model terms: treatment and baseline HDL-C value
SecondaryPercent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)-23.3 (-25.3 to -21.4)-9.0 (-11.0 to -7.1)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -14.3 · 95% CI -17.1 to -11.6Model terms: treatment and baseline non-HDL-C value
SecondaryPercent Change From Baseline to Week 6 in Total-Cholesterol

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Total-Cholesterol
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Total-Cholesterol-16.9 (-18.3 to -15.4)-6.9 (-8.4 to -5.5)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -10.0 · 95% CI -12.0 to -7.9Model terms: treatment and baseline Total-C value
SecondaryPercent Change From Baseline to Week 6 in Triglycerides (TG)

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Triglycerides (TG)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Triglycerides (TG)-12.3 (-16.3 to -8.2)-5.9 (-10.2 to -0.7)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · Nonparametric ANCOVA · p = <0.001 · Median difference (final values): -7.3 · 95% CI -11.5 to -3.1The median difference is based on the Hodges-Lehmann estimates of shift; The distribution-free 95% CI is based on Wilcoxon's rank sum test statistic.
SecondaryPercent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)-17.8 (-19.6 to -16.0)-7.7 (-9.5 to -5.8)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -10.1 · 95% CI -12.7 to -7.6Model terms: treatment and baseline Apo B value
SecondaryPercent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)-0.3 (-1.5 to 0.9)-1.2 (-2.3 to -0.0)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = 0.313 · Mean difference (final values): 0.9 · 95% CI -0.8 to 2.5Model terms: treatment and baseline Apo A-I value
SecondaryPercent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio-16.0 (-176.6 to -14.4)-5.6 (-7.2 to -4.1)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -10.4 · 95% CI -12.6 to -8.2Model terms: treatment and baseline Total-C:HDL-C value
SecondaryPercent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent change
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
Percent changeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio-26.4 (-28.8 to -24.0)-9.9 (-12.3 to -7.5)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -16.5 · 95% CI -19.9 to -13.1Model terms: treatment and baseline LDL-C:HDL-C value
SecondaryPercent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio-16.9 (-18.9 to -14.9)-5.9 (-7.9 to -3.9)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -11.0 · 95% CI -13.8 to -8.2Model terms: treatment and baseline Apo B:Apo A-I value
SecondaryPercent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio-22.2 (-24.5 to -19.9)-7.6 (-9.9 to -5.4)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · ANCOVA · p = <0.001 · Mean difference (final values): -14.5 · 95% CI -17.7 to -11.3Model terms: treatment and baseline non-HDL-C:HDL-C value
SecondaryPercent Change From Baseline to Week 6 in C Reactive Protein (CRP)

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

Time frame:
Baseline and 6 Weeks
Reported as:
Least squares mean · Percent Change
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
Percent ChangeAtorvastatin + EzetemibeAtorvastatin
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)-18.3 (-25.0 to -11.1)-11.5 (-18.7 to -3.6)
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · Longitudinal Data Analysis (LDA) · p = 0.174 · Mean difference (final values): -6.8 · 95% CI -17.1 to 3.4Data for analysis was transformed by the natural log and the difference in geometric mean % change from BL calculated based on the difference in the back-transformed least squares means.
SecondaryNumber of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
Time frame:
6 Weeks
Reported as:
Number · Participants
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
ParticipantsAtorvastatin + EzetemibeAtorvastatin
<70 mg/dL20488
>=70 mg/dL73191
Statistical analysis
  • Atorvastatin + Ezetemibe vs Atorvastatin · Regression, Logistic · p = <0.001 · Odds ratio (or): 8.37 · 95% CI 5.45 to 12.84Model terms: treatment and baseline LDL-C value

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atorvastatin + Ezetemibe———
Atorvastatin———
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventAtorvastatin + EzetemibeAtorvastatin
Myocardial infarctionCardiac disorders3/2861/289
Cardiac failure congestiveCardiac disorders1/2860/289
Chest painGeneral disorders1/2860/289
Non-cardiac chest painGeneral disorders1/2860/289
PneumoniaInfections and infestations1/2860/289
PresyncopeNervous system disorders1/2860/289
Benign prostatic hyperplasiaReproductive system and breast disorders1/2860/289
Pulmonary haemorrhageRespiratory, thoracic and mediastinal disorders1/2860/289
Hypertensive crisisVascular disorders1/2860/289
Labile hypertensionVascular disorders1/2860/289
Most frequent other events
Showing 10 of 106
Most frequent other events
EventAtorvastatin + EzetemibeAtorvastatin
Upper respiratory tract infectionInfections and infestations1/2867/289
DiarrhoeaGastrointestinal disorders0/2866/289
MyalgiaMusculoskeletal and connective tissue disorders1/2865/289
BronchitisInfections and infestations4/2861/289
NasopharyngitisInfections and infestations4/2861/289
Pain in extremityMusculoskeletal and connective tissue disorders4/2863/289
HeadacheNervous system disorders4/2862/289
FatigueGeneral disorders0/2864/289
ArthralgiaMusculoskeletal and connective tissue disorders0/2864/289
Myocardial infarctionCardiac disorders3/2861/289

Baseline characteristics

Age, Continuous
Age, Continuous(years)Atorvastatin + EzetemibeAtorvastatinTotal
Mean60.6 (31 to 80)62 (34 to 79)61.3 (31 to 80)
Sex: Female, Male
Sex: Female, Male(Participants)Atorvastatin + EzetemibeAtorvastatinTotal
Female115113228
Male173178351
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Atorvastatin + EzetemibeAtorvastatinTotal
White237232469
Asian4812
Black322961
Multi-Racial152237
Apolipoprotein A-I
Apolipoprotein A-I(mg/dL)Atorvastatin + EzetemibeAtorvastatinTotal
Mean154.0 ± 25.5154.6 ± 25.0154.3 ± 25.3
Apolipoprotein B
Apolipoprotein B(mg/dL)Atorvastatin + EzetemibeAtorvastatinTotal
Mean101.3 ± 19.0102.0 ± 18.8101.7 ± 18.9
Apolipoprotein B:Apolipoprotein A-I ratio
Apolipoprotein B:Apolipoprotein A-I ratio(Ratio)Atorvastatin + EzetemibeAtorvastatinTotal
Mean0.7 ± 0.20.7 ± 0.20.7 ± 0.2
C Reactive Protein
C Reactive Protein(mg/dL)Atorvastatin + EzetemibeAtorvastatinTotal
Mean1.8 ± 2.71.5 ± 3.01.6 ± 2.8
High-Density Lipoprotein
High-Density Lipoprotein(mg/dL)Atorvastatin + EzetemibeAtorvastatinTotal
Mean47.4 ± 10.547.2 ± 10.647.3 ± 10.5

7 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Leiter LA, Bays H, Conard S, Bird S, Rubino J, Hanson ME, Tomassini JE, Tershakovec AM. Efficacy and safety of ezetimibe added on to atorvastatin (40 mg) compared with uptitration of atorvastatin (to 80 mg) in hypercholesterolemic patients at high risk of coronary heart disease. Am J Cardiol. 2008 Dec 1;102(11):1495-501. doi: 10.1016/j.amjcard.2008.09.076. Epub 2008 Oct 23. PubMed 19026303 ↗
  • Bays H, Conard S, Leiter LA, Bird S, Jensen E, Hanson ME, Shah A, Tershakovec AM. Are post-treatment low-density lipoprotein subclass pattern analyses potentially misleading? Lipids Health Dis. 2010 Nov 30;9:136. doi: 10.1186/1476-511X-9-136. PubMed 21118495 ↗
  • Conard S, Bays H, Leiter LA, Bird S, Lin J, Hanson ME, Shah A, Tershakovec AM. Ezetimibe added to atorvastatin compared with doubling the atorvastatin dose in patients at high risk for coronary heart disease with diabetes mellitus, metabolic syndrome or neither. Diabetes Obes Metab. 2010 Mar;12(3):210-8. doi: 10.1111/j.1463-1326.2009.01152.x. PubMed 20151997 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00276484
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Jan 13, 2006
Start date
Feb 2006
Primary completion
Feb 2008
Completion
Mar 2008
Results posted
Apr 13, 2009
Last update
May 14, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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