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

A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157924

Enrollment

190

Registered

2005-09-12

Start date

2005-11-30

Completion date

2007-09-30

Last updated

2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

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

Interventions

DRUGsimvastatin (+) ezetimibe

simvastatin (+) ezetimibe 10/20mg.

DRUGatorvastatin

atorvastatin 10mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
LDL-C lowering efficacy	6 weeks

Secondary

Measure	Time frame
Safety	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026