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

Phase 4

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: atorvastatin

• Registration Number: NCT00645424
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study Completion: 2004-10
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	atorvastatin	-
Arm B	atorvastatin	-
Arm C	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
Percentage change in LDL-C levels from baseline to Week 12	Week 12
Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12	Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12	Weeks 4, 8, and 12
Vital signs at Weeks 4, 8, and 12	Screening and at Weeks 4, 8, and 12
Percentage change in LDL-C levels from baseline at Weeks 4 and 8	Weeks 4 and 8
Percentage of LDL-C responders at Weeks 4 and 8	Weeks 4 and 8
Adverse events at Weeks 4, 8, and 12	Baseline and at Weeks 4, 8, and 12
Clinical laboratory changes at Weeks 4, 8, and 12	Screening and at Weeks 4, 8, and 12
Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12	Weeks 4, 8, and 12

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taoyuan Hsien, Taiwan