Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Atorvastatin + Ezetimibe	Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin	Atorvastatin 40 mg Daily for 6 weeks

Participant Flow:   Overall Study

	Atorvastatin + Ezetimibe	Atorvastatin
STARTED	98	98
COMPLETED	92	91
NOT COMPLETED	6	7
Adverse Event	0	2
Lost to Follow-up	2	2
Protocol Violation	4	3

Reporting Groups

	Description
Atorvastatin + Ezetimibe	Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
Atorvastatin	Atorvastatin 40 mg Daily for 6 weeks

Baseline Measures

	Atorvastatin + Ezetimibe	Atorvastatin	Total
Number of Participants   [units: participants]	98	98	196
Age   [units: years] Mean ( Full Range )	56.4 ( 24 to 78 )	58.0 ( 34 to 76 )	57.2 ( 24 to 78 )
Gender   [units: participants]
Female	40	49	89
Male	58	49	107
Race/Ethnicity, Customized   [units: 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   [units: mg/dL] Mean ± Standard Deviation	161.8 ± 25.2	163.4 ± 24.6	162.6 ± 24.8
Apolipoprotein A-I:Apolipoprotein B ratio   [units: Ratio] Mean ± Standard Deviation	0.8 ± 0.2	0.7 ± 0.2	0.8 ± 0.2
Apolipoprotein B   [units: mg/dL] Mean ± Standard Deviation	122.9 ± 22.4	119.9 ± 21.0	121.4 ± 21.7
C Reactive Protein   [units: mg/dL] Mean ± Standard Deviation	1.6 ± 2.6	1.2 ± 1.7	1.5 ± 2.1
High Density Lipoprotein (HDL)   [units: mg/dL] Mean ± Standard Deviation	51.1 ± 12.1	51.7 ± 11.5	51.4 ± 11.8
Low Density Lipoprotein (LDL)   [units: mg/dL] Mean ± Standard Deviation	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   [units: Ratio] Mean ± Standard Deviation	2.4 ± 0.6	2.5 ± 0.7	2.4 ± 0.7
Non- High Density Lipoprotein (Non-HDL) Cholesterol   [units: mg/dL] Mean ± Standard Deviation	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   [units: Ratio] Mean ± Standard Deviation	3.2 ± 1.0	3.0 ± 0.9	3.1 ± 1.0
Total Cholesterol   [units: mg/dL] Mean ± Standard Deviation	202.6 ± 25.2	200.0 ± 21.5	201.3 ± 23.4
Total cholesterol:High Density Lipoprotein Cholesterol (HDL-C) ratio   [units: Ratio] Mean ± Standard Deviation	4.2 ± 1.0	4.0 ± 0.9	4.1 ± 1.0
Triglycerides (TG)   [units: mg/dL] Mean ± Standard Deviation	152.5 ± 68.8	147.8 ± 75.3	149.0 ± 75.3

1.  Primary:

Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6   [ 6 weeks ]

2.  Secondary:

Percent Change in High Density Lipoprotein -Cholesterol (HDL-C)at Week 6   [ 6 weeks ]

3.  Secondary:

Percent Change in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 6   [ 6 Weeks ]

4.  Secondary:

Percent Change From Baseline in Total-Cholesterol at Week 6   [ 6 Weeks ]

5.  Secondary:

Percent Change From Baseline in Triglycerides (TG) at Week 6   [ 6 weeks ]

6.  Secondary:

Percent Change From Baseline in Apolipoprotein B at Week 6   [ 6 Weeks ]

7.  Secondary:

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

8.  Secondary:

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

9.  Secondary:

Percent Change From Baseline in Apolipoprotein B: Apolipoprotein A-I Ratio at Week 6   [ 6 Weeks ]

10.  Secondary:

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

11.  Secondary:

Percent Change From Baseline in C-Reactive Protein (CRP) at Week 6   [ 6 Weeks ]

12.  Secondary:

Number of Participants Who Attained Target LDL-C <100 mg/dL at Week 6   [ 6 weeks ]

13.  Post-Hoc:

Percent Change in Apolipoprotein A-I at Week 6   [ 6 Weeks ]

14.  Post-Hoc:

Percent Change in C-Reactive Protein (CRP) at Week 6   [ 6 weeks ]