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

Hyperlipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645424
• Other study ID #: A2581123
• Status: Completed
• Phase: Phase 4
• Start date: December 2003
• Est. completion date: October 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

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

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taoyuan Hsien

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in LDL-C levels from baseline to Week 12		Week 12
Primary	Percentage of subjects with low-density lipoprotein cholesterol (LDL-C) levels of <100 mg/dL (LDL-C responders) at Week 12		Week 12
Secondary	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
Secondary	Adverse events at Weeks 4, 8, and 12		Baseline and at Weeks 4, 8, and 12
Secondary	Clinical laboratory changes at Weeks 4, 8, and 12		Screening and at Weeks 4, 8, and 12
Secondary	Vital signs at Weeks 4, 8, and 12		Screening and at Weeks 4, 8, and 12
Secondary	Percentage change in LDL-C levels from baseline at Weeks 4 and 8		Weeks 4 and 8
Secondary	Percentage of LDL-C responders at Weeks 4 and 8		Weeks 4 and 8
Secondary	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

External Links

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