Official Title: “A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: atorvastatin
  • Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
• Drug: atorvastatin
  • Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
• Drug: atorvastatin
  • Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm A
• Experimental: Arm B
• Experimental: Arm C

Primary Measures

• Percentage change in LDL-C levels from baseline to Week 12
  • Time Frame: Week 12
    Safety Issue?: No
• Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
  • Time Frame: Weeks 4, 8, and 12
    Safety Issue?: No
• Adverse events at Weeks 4, 8, and 12
  • Time Frame: Baseline and at Weeks 4, 8, and 12
    Safety Issue?: Yes
• Clinical laboratory changes at Weeks 4, 8, and 12
  • Time Frame: Screening and at Weeks 4, 8, and 12
    Safety Issue?: Yes
• Vital signs at Weeks 4, 8, and 12
  • Time Frame: Screening and at Weeks 4, 8, and 12
    Safety Issue?: Yes
• Percentage change in LDL-C levels from baseline at Weeks 4 and 8
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Percentage of LDL-C responders at Weeks 4 and 8
  • Time Frame: Weeks 4 and 8
    Safety Issue?: No
• Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
  • Time Frame: Weeks 4, 8, and 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645424

Study ID Number: A2581123

ClinicalTrials.gov Identifier: NCT00645424

Health Authority: Taiwan: Department of Health

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting: