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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Comparator: atorvastatin; Drug: Comparator: Placebo; Drug: Comparator: Placebo.; Drug: Comparator: ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276458

2005_104

0653-079

Details and patient eligibility

About

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Enrollment: 196 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with LDL-C >100 mg/dL & on a stable dose of atorvastatin 20 mg

Exclusion criteria

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe or atorvastatin
• Patient with diabetes or coronary heart disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 2 patient groups

1

Active Comparator group

Description:

Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day).

Treatment:

Drug: Comparator: atorvastatin

Drug: Comparator: Placebo

2

Experimental group

Description:

Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).

Treatment:

Drug: Comparator: Placebo.

Drug: Comparator: ezetimibe