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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00276458
Recruitment Status : Completed
First Posted : January 13, 2006
Results First Posted : July 8, 2009
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Comparator: atorvastatin
Drug: Comparator: Placebo
Drug: Comparator: ezetimibe
Drug: Comparator: Placebo.
Enrollment 196
Recruitment Details

Phase III

First Patient In: 4/5/2006; Last Patient Last Visit 1/17/2008

72 centers worldwide (US, Canada, Austria, Costa Rica)

Eligible patients include those on a stable dose of atorvastatin 20 mg; or patients with adjusted LDL-C pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.

Pre-assignment Details

Patients received and were blinded to atorvastatin 20 mg for a 4/5- week run-in period.

Patients needed an LDL-C ≥ 100 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 40 mg or addition of ezetimibe 10 mg to their 20 mg dose of atorvastatin for a 6-week treatment period.

Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks Atorvastatin 40 mg Daily for 6 weeks
Period Title: Overall Study
Started 98 98
Completed 92 91
Not Completed 6 7
Reason Not Completed
Adverse Event             0             2
Lost to Follow-up             2             2
Protocol Violation             4             3
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin Total
Hide Arm/Group Description Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks Atorvastatin 40 mg Daily for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 98 98 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 98 participants 98 participants 196 participants
56.4
(24 to 78)
58.0
(34 to 76)
57.2
(24 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 196 participants
Female
40
  40.8%
49
  50.0%
89
  45.4%
Male
58
  59.2%
49
  50.0%
107
  54.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 98 participants 196 participants
White 58 60 118
American Indian or Alaska Native 1 0 1
Asian 7 8 15
Black 3 9 12
Multi-Racial 29 21 50
Apolipoprotein A-I  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
161.8  (25.2) 163.4  (24.6) 162.6  (24.8)
Apolipoprotein A-I:Apolipoprotein B ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 98 participants 98 participants 196 participants
0.8  (0.2) 0.7  (0.2) 0.8  (0.2)
Apolipoprotein B  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
122.9  (22.4) 119.9  (21.0) 121.4  (21.7)
C Reactive Protein  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
1.6  (2.6) 1.2  (1.7) 1.5  (2.1)
High Density Lipoprotein (HDL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
51.1  (12.1) 51.7  (11.5) 51.4  (11.8)
Low Density Lipoprotein (LDL)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
119.9  (19.4) 117.9  (16.8) 118.9  (18.1)
Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 98 participants 98 participants 196 participants
2.4  (0.6) 2.5  (0.7) 2.4  (0.7)
Non- High Density Lipoprotein (Non-HDL) Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
151.6  (24.1) 148.4  (21.1) 150.0  (22.7)
NonHigh Density Lipoprotein-Cholesterol (NonHDL-C):High Density Lipoprotein-Cholesterol (HDL-C)ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 98 participants 98 participants 196 participants
3.2  (1.0) 3.0  (0.9) 3.1  (1.0)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
202.6  (25.2) 200.0  (21.5) 201.3  (23.4)
Total cholesterol:High Density Lipoprotein Cholesterol (HDL-C) ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 98 participants 98 participants 196 participants
4.2  (1.0) 4.0  (0.9) 4.1  (1.0)
Triglycerides (TG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 98 participants 98 participants 196 participants
152.5  (68.8) 147.8  (75.3) 149.0  (75.3)
1.Primary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-30.8
(-34.5 to -27.0)
-10.9
(-14.7 to -7.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline LDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.9
Confidence Interval 95%
-25.2 to -14.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.7
Estimation Comments (Atorva + EZ minus Atorva)
2.Secondary Outcome
Title Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
3.2
(0.2 to 6.2)
0.8
(-2.2 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline HDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval 95%
-1.9 to 6.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1
Estimation Comments (Atorva + EZ minus Atorva)
3.Secondary Outcome
Title Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-26.7
(-30.1 to -23.3)
-10.2
(-13.6 to -6.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline non-HDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.4
Confidence Interval 95%
-21.2 to -11.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4
Estimation Comments (Atorva + EZ minus Atorva)
4.Secondary Outcome
Title Percent Change From Baseline in Total-Cholesterol at Week 6
Hide Description ([6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
-19.7
(-22.2 to -17.1)
-7.4
(-10.0 to -4.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline Total-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.2
Confidence Interval 95%
-15.8 to -8.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.8
Estimation Comments (Atorva + EZ minus Atorva)
5.Secondary Outcome
Title Percent Change From Baseline in Triglycerides (TG) at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-17.8
(-23.7 to -11.4)
-5.5
(-14.4 to 0.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value
Method Nonparametric ANCOVA
Comments ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline triglycerides value.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -8.9
Confidence Interval 95%
-17.7 to -0.4
Estimation Comments

The 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.

(Atorva + EZ minus Atorva)

6.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 89 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-21.4
(-24.3 to -18.5)
-7.7
(-10.6 to -4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline Apo B value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.7
Confidence Interval 95%
-17.8 to -9.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.1
Estimation Comments (Atorva + EZ minus Atorva)
7.Secondary Outcome
Title Percent Change From Baseline in Total-Cholesterol:High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-20.6
(-23.7 to -17.5)
-7.5
(-10.6 to -4.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline Total-C:HDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.1
Confidence Interval 95%
-17.5 to -8.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.2
Estimation Comments (Atorva + EZ minus Atorva)
8.Secondary Outcome
Title Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-31.9
(-35.8 to -27.9)
-11.0
(-14.9 to -7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline LDL-C:HDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.9
Confidence Interval 95%
-26.5 to -15.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.8
Estimation Comments (Atorva + EZ minus Atorva)
9.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 89 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-19.0
(-22.3 to -15.6)
-5.8
(-9.2 to -2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline Apo B:Apo A-I value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.1
Confidence Interval 95%
-17.9 to -8.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.4
Estimation Comments (Atorva + EZ minus Atorva)
10.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C):High Density Lipoprotein Cholesterol (HDL-C) Ratio at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-27.2
(-31.4 to -23.0)
-9.9
(-14.1 to -5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline non-HDL-C:HDL-C value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.3
Confidence Interval 95%
-23.2 to -11.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.0
Estimation Comments (Atorva + EZ minus Atorva)
11.Secondary Outcome
Title Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 89 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
-6.7
(-23.7 to 14.2)
-9.2
(-25.8 to 11.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method Longitudinal Data Analysis (LDA)
Comments LDA method of Liang and Zeger with model terms: treatment, time, and the interaction of time by treatment
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval 95%
-23.8 to 28.8
Estimation Comments

Data 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.

(Atorva + EZ minus Atorva)

12.Secondary Outcome
Title Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 92 92
Measure Type: Number
Unit of Measure: Participants
<100 mg/dL 77 45
≥100 mg/dL 15 47
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Model terms: treatment and baseline LDL-C value
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.60
Confidence Interval 95%
3.80 to 19.47
Estimation Comments Estimated ratio is the predictive odds of attaining LDL-C target on Atorva + EZ versus Atorva.
13.Post-Hoc Outcome
Title Percent Change in Apolipoprotein A-I at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 89 90
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-1.9
(-4.2 to 0.4)
-1.2
(-3.5 to 1.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment and baseline Apo A-I value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval 95%
-3.9 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments (Atorva + EZ minus Atorva)
14.Post-Hoc Outcome
Title Percent Change in C-Reactive Protein (CRP) at Week 6
Hide Description [(6 week value - baseline value)/baseline value]*100%.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description:
Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin 40 mg Daily for 6 weeks
Overall Number of Participants Analyzed 89 89
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-19.2
(-25.0 to -4.0)
-9.1
(-22.2 to 5.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atorvastatin + Ezetimibe, Atorvastatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.839
Comments [Not Specified]
Method Nonparametric ANCOVA
Comments ANCOVA using ranks based on normal scores (Tukey method) with model terms for treatment and baseline CRP value
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.3
Confidence Interval 95%
-26.1 to 8.3
Estimation Comments

The 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.

(Atorva + EZ minus Atorva)

Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atorvastatin + Ezetimibe Atorvastatin
Hide Arm/Group Description Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks Atorvastatin 40 mg Daily for 6 weeks
All-Cause Mortality
Atorvastatin + Ezetimibe Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Atorvastatin + Ezetimibe Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/98 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atorvastatin + Ezetimibe Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   17/96 (17.71%)   22/98 (22.45%) 
Ear and labyrinth disorders     
Vertigo * 1  2/96 (2.08%)  0/98 (0.00%) 
Gastrointestinal disorders     
Abdominal tenderness * 1  1/96 (1.04%)  0/98 (0.00%) 
Constipation * 1  0/96 (0.00%)  1/98 (1.02%) 
Gastrointestinal Disorder * 1  0/96 (0.00%)  1/98 (1.02%) 
Irritable bowel syndrome * 1  0/96 (0.00%)  2/98 (2.04%) 
Nausea * 1  0/96 (0.00%)  1/98 (1.02%) 
General disorders     
Chest Discomfort * 1  1/96 (1.04%)  0/98 (0.00%) 
Fatigue * 1  2/96 (2.08%)  1/98 (1.02%) 
Edema * 1  1/96 (1.04%)  0/98 (0.00%) 
Alanine aminotransferase increased * 1  1/96 (1.04%)  1/98 (1.02%) 
Aspartate aminotransferase increased * 1  1/96 (1.04%)  0/98 (0.00%) 
Blood creatinine phosphokinase increased * 1  0/96 (0.00%)  1/98 (1.02%) 
Gamma-glutamyltransferase increased * 1  1/96 (1.04%)  0/98 (0.00%) 
Transaminases increased * 1  0/96 (0.00%)  1/98 (1.02%) 
Infections and infestations     
Gastroenteritis * 1  1/96 (1.04%)  1/98 (1.02%) 
Influenza * 1  0/96 (0.00%)  1/98 (1.02%) 
Nasopharyngitis * 1  2/96 (2.08%)  0/98 (0.00%) 
Oral herpes * 1  1/96 (1.04%)  0/98 (0.00%) 
Sinusitis * 1  0/96 (0.00%)  1/98 (1.02%) 
Upper respiratory tract infection * 1  1/96 (1.04%)  0/98 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc disorder * 1  0/96 (0.00%)  1/98 (1.02%) 
Myalgia * 1  1/96 (1.04%)  0/98 (0.00%) 
Pain in extremity * 1  0/96 (0.00%)  1/98 (1.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Seborrhoeic keratosis * 1  0/96 (0.00%)  1/98 (1.02%) 
Nervous system disorders     
Dizziness * 1  0/96 (0.00%)  1/98 (1.02%) 
Headache * 1  0/96 (0.00%)  1/98 (1.02%) 
Psychiatric disorders     
Insomnia * 1  1/96 (1.04%)  0/98 (0.00%) 
Renal and urinary disorders     
Renal impairment * 1  0/96 (0.00%)  1/98 (1.02%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  0/96 (0.00%)  1/98 (1.02%) 
Pharyngolaryngeal pain * 1  0/96 (0.00%)  1/98 (1.02%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis * 1  0/96 (0.00%)  1/98 (1.02%) 
Vascular disorders     
Hypertension * 1  0/96 (0.00%)  1/98 (1.02%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
194 out of 196 randomized patients took at least one dose of blinded study therapy and were included in the safety analysis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00276458    
Other Study ID Numbers: 0653-079
2005_104
First Submitted: January 10, 2006
First Posted: January 13, 2006
Results First Submitted: December 18, 2008
Results First Posted: July 8, 2009
Last Update Posted: April 4, 2017