To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: ezetimibe; Drug: atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276484

2005_105

0653-090

Details and patient eligibility

About

To Evaluate and Compare the Efficacy and Safety of Ezetimibe Plus Atorvastatin Versus Atorvastatin in Hypercholesterolemic Patients at High Risk for Coronary Heart Disease Not Adequately Controlled on Atorvastatin 40 mg.

Enrollment: 579 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with LDL-C >70 mg/dL & on a stable dose of atorvastatin 40 mg

Exclusion criteria

• Pregnant or lactating women or intending to become pregnant
• Patient with sensitivity or intolerance to ezetimibe or atorvastatin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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579 participants in 2 patient groups

1

Active Comparator group

Description:

Atorvastatin 80 mg

Treatment:

Drug: atorvastatin

Drug: atorvastatin

2

Experimental group

Description:

Atorvastatin 40 mg + ezetimibe 10 mg

Treatment:

Drug: atorvastatin

Drug: ezetimibe

Drug: atorvastatin