A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperlipidemias
Intervention: atorvastatin (Drug); atorvastatin (Drug); atorvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage change in LDL-C levels from baseline to Week 12Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12
Secondary outcome: Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12Adverse events at Weeks 4, 8, and 12 Clinical laboratory changes at Weeks 4, 8, and 12 Vital signs at Weeks 4, 8, and 12 Percentage change in LDL-C levels from baseline at Weeks 4 and 8 Percentage of LDL-C responders at Weeks 4 and 8 Percentage of subjects with total cholesterol (TC) levels of <160 mg/dL (TC responders) at Weeks 4, 8, and 12
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Pfizer Investigational Site, Taichung, Taiwan
Pfizer Investigational Site, Kaohsiung Hsien, Taiwan
Pfizer Investigational Site, Kaohsiung, Taiwan
Pfizer Investigational Site, Taoyuan Hsien, Taiwan
Pfizer Investigational Site, Taipei, Taiwan
Additional Information
To obtain contact information for a study center near you, click here. Link to ClinicalStudyResults.org Posting:
Starting date: December 2003
Ending date: October 2004
Last updated: April 28, 2008
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