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

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
atorvastatin
atorvastatin
atorvastatin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage change from baseline in TC, high-density lipoprotein cholesterol, triglycerides, and high sensitivity C-reactive protein at Weeks 4, 8, and 12
Adverse 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

Full Information

First Posted
March 24, 2008
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00645424
Brief Title
A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Experimental
Arm Title
Arm C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
Atorvastatin calcium tablets 10 mg orally once daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
Atorvastatin calcium tablets 20 mg orally once daily in the evening for 12 weeks
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Intervention Description
Atorvastatin calcium tablets 40 mg orally once daily in the evening for 12 weeks
Primary Outcome Measure Information:
Title
Percentage change in LDL-C levels from baseline to Week 12
Time Frame
Week 12
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Adverse events at Weeks 4, 8, and 12
Time Frame
Baseline and at Weeks 4, 8, and 12
Title
Clinical laboratory changes at Weeks 4, 8, and 12
Time Frame
Screening and at Weeks 4, 8, and 12
Title
Vital signs at Weeks 4, 8, and 12
Time Frame
Screening and at Weeks 4, 8, and 12
Title
Percentage change in LDL-C levels from baseline at Weeks 4 and 8
Time Frame
Weeks 4 and 8
Title
Percentage of LDL-C responders at Weeks 4 and 8
Time Frame
Weeks 4 and 8
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taoyuan Hsien
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581123&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Efficacy%20Of%20Lipitor%20In%20Patients%20With%20Diabetes%20And%20High%20Cholesterol
Description
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A Study To Evaluate The Safety And Efficacy Of Atorvastatin In Patients With Diabetes And High Cholesterol

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