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

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 ]