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: 4/6/2006; 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.

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 40 mg for a 4/5- week run-in period. Patients needed an LDL-C ≥ 70 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 80 mg or addition of ezetimibe 10 mg to their 40 mg dose of atorvastatin for a 6-week treatment period.

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Participant Flow:   Overall Study

	Atorvastatin + Ezetemibe	Atorvastatin
STARTED	288	291
COMPLETED	279	278
NOT COMPLETED	9	13
Adverse Event	4	7
Lost to Follow-up	1	1
Protocol Violation	0	1
Withdrawal by Subject	4	3
Could not take time off work	0	1

Reporting Groups

	Description
Atorvastatin + Ezetemibe	Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
Atorvastatin	Atorvastatin 80 mg every day for 6 weeks

Baseline Measures

	Atorvastatin + Ezetemibe	Atorvastatin	Total
Number of Participants   [units: participants]	288	291	579
Age   [units: years] Mean ( Full Range )	60.6 ( 31 to 80 )	62 ( 34 to 79 )	61.3 ( 31 to 80 )
Gender   [units: participants]
Female	115	113	228
Male	173	178	351
Race/Ethnicity, Customized   [units: Participants]
White	237	232	469
Asian	4	8	12
Black	32	29	61
Multi-Racial	15	22	37
Apolipoprotein A-I   [units: mg/dL] Mean ± Standard Deviation	154.0 ± 25.5	154.6 ± 25.0	154.3 ± 25.3
Apolipoprotein B   [units: mg/dL] Mean ± Standard Deviation	101.3 ± 19.0	102.0 ± 18.8	101.7 ± 18.9
Apolipoprotein B:Apolipoprotein A-I ratio   [units: Ratio] Mean ± Standard Deviation	0.7 ± 0.2	0.7 ± 0.2	0.7 ± 0.2
C Reactive Protein   [units: mg/dL] Mean ± Standard Deviation	1.8 ± 2.7	1.5 ± 3.0	1.6 ± 2.8
High-Density Lipoprotein   [units: mg/dL] Mean ± Standard Deviation	47.4 ± 10.5	47.2 ± 10.6	47.3 ± 10.5
Low-Density Lipoprotein   [units: mg/dL] Mean ± Standard Deviation	88.8 ± 16.2	89.8 ± 16.2	89.4 ± 16.2
Low-Density Lipoprotein-C:High-Density Lipoprotein-C ratio   [units: Ratio] Mean ± Standard Deviation	2.0 ± 0.6	2.0 ± 0.6	2.0 ± 0.6
Non-High-Density Lipoprotein Cholesterol   [units: mg/dL] Mean ± Standard Deviation	117.7 ± 20.8	118.1 ± 21.9	117.9 ± 21.4
Non-High-Density Lipoprotein-C:High-Density Lipoprotein-C ratio   [units: Ratio] Mean ± Standard Deviation	2.6 ± 0.8	2.6 ± 0.8	2.6 ± 0.8
Total Cholesterol   [units: mg/dL] Mean ± Standard Deviation	165.2 ± 21.4	165.3 ± 22.8	165.2 ± 22.1
Total cholesterol:High-Density Lipoprotein-C ratio   [units: Ratio] Mean ± Standard Deviation	3.6 ± 0.8	3.6 ± 0.8	3.6 ± 0.8
Triglycerides   [units: mg/dL] Median ± Standard Deviation	132.5 ± 72.1	134.0 ± 72.1	133.5 ± 72.1

1.  Primary:

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

2.  Secondary:

Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)   [ Baseline and 6 weeks ]

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

Percent Change From Baseline to Week 6 in Triglycerides (TG)   [ Baseline and 6 Weeks ]

6.  Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)   [ Baseline and 6 Weeks ]

7.  Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)   [ Baseline and 6 Weeks ]

8.  Secondary:

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

9.  Secondary:

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

10.  Secondary:

Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio   [ Baseline and 6 Weeks ]

11.  Secondary:

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

12.  Secondary:

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

13.  Secondary:

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