A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

Viatris

Status and phase: Completed; Phase 4

Conditions: Hyperlipidemias

Treatments: Drug: atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645424

A2581123

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of atorvastatin for the treatment of Taiwanese patients with diabetes and high cholesterol.

Enrollment: 155 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult Taiwanese outpatients with type 2 diabetes mellitus and high cholesterol
• Hemoglobin A1c levels of ≤10%, LDL-C levels of ≥130 mg/dL, and serum triglyceride levels of <400 mg/dL

Exclusion criteria

• Type I diabetes mellitus
• Secondary causes of high cholesterol
• Elevated liver enzymes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Arm A

Experimental group

Treatment:

Drug: atorvastatin

Drug: atorvastatin

Drug: atorvastatin

Arm B

Experimental group

Treatment:

Drug: atorvastatin

Drug: atorvastatin

Drug: atorvastatin

Arm C

Experimental group

Treatment:

Drug: atorvastatin

Drug: atorvastatin

Drug: atorvastatin