Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

Organon

Status and phase: Completed; Phase 4

Conditions: Hypercholesterolemia

Treatments: Drug: atorvastatin; Drug: simvastatin (+) ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157924

2005_064

0653A-093

MK0653A-093

Details and patient eligibility

About

An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of hypercholesterolemia
• Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion criteria

• Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

1

Experimental group

Description:

1. simvastatin/ezetimibe 10/20mg

Treatment:

Drug: simvastatin (+) ezetimibe

2

Active Comparator group

Description:

2. atorvastatin 10mg

Treatment:

Drug: atorvastatin