A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
A Randomized, 12-Week, Open Labeled Study To Evaluate The Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia
1 other identifier
interventional
155
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2003
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 24, 2008
CompletedFirst Posted
Study publicly available on registry
March 27, 2008
CompletedFebruary 18, 2021
February 1, 2021
March 24, 2008
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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
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
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
- +2 more secondary outcomes
Study Arms (3)
Arm A
EXPERIMENTALArm B
EXPERIMENTALArm C
EXPERIMENTALInterventions
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Type I diabetes mellitus
- Secondary causes of high cholesterol
- Elevated liver enzymes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pfizer Investigational Site
Kaohsiung City, Taiwan
Pfizer Investigational Site
Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Taichung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Pfizer Investigational Site
Taoyuan Hsien, Taiwan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2008
First Posted
March 27, 2008
Study Start
December 1, 2003
Study Completion
October 1, 2004
Last Updated
February 18, 2021
Record last verified: 2021-02