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

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 ]