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Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 4
Locations
International
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 Dyslipidemias

Eligibility Criteria

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

Inclusion Criteria:

  • Dyslipidemic patients who were eligible for lipid lowering therapy
  • Willingness to follow study diet for 1 month prior to screening and for the duration of the study

Exclusion Criteria:

  • Use of other lipid lowering agents (6-week washout period)
  • Uncontrolled high blood pressure
  • Impaired liver function

Sites / Locations

  • 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

High Risk

Low Risk

Medium Risk

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target

Secondary Outcome Measures

Adverse events and laboratory test changes
Percentage of patients who achieved LDL-C target
Change and percent change from baseline in LDL-C
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Change and percent change from baseline in LDL/HDL ratio
Change and percent change from baseline in total cholesterol
Change and percent change from baseline in triglycerides

Full Information

First Posted
March 26, 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
NCT00647543
Brief Title
Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
Official Title
A Multicenter, Eight-Week Treatment, Single-Step Titration, Open-Label Study Assessing The Percentage Of Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, And 40 Mg
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 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 of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
High Risk
Arm Type
Experimental
Arm Title
Low Risk
Arm Type
Experimental
Arm Title
Medium Risk
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin tablets at starting doses of 10, 20, or 40 mg once daily for at least 8 weeks. Patients who achieved their LDL-C target by Week 4 continued on their starting dose for the next 4 weeks. Patients who did not achieve their LDL-C target by Week 4 were titrated up 1 dose step for the next 4 weeks.
Primary Outcome Measure Information:
Title
Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Adverse events and laboratory test changes
Time Frame
Weeks 2, 4, and 8
Title
Percentage of patients who achieved LDL-C target
Time Frame
Weeks 2 and 4, and Week 8 with 1 step titration
Title
Change and percent change from baseline in LDL-C
Time Frame
Weeks 2, 4, and 8
Title
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time Frame
Weeks 2, 4, and 8
Title
Change and percent change from baseline in LDL/HDL ratio
Time Frame
Weeks 2, 4, and 8
Title
Change and percent change from baseline in total cholesterol
Time Frame
Weeks 2, 4, and 8
Title
Change and percent change from baseline in triglycerides
Time Frame
Weeks 2, 4, and 8

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: Dyslipidemic patients who were eligible for lipid lowering therapy Willingness to follow study diet for 1 month prior to screening and for the duration of the study Exclusion Criteria: Use of other lipid lowering agents (6-week washout period) Uncontrolled high blood pressure Impaired liver function
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
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581111&StudyName=Lipitor%20Study%20For%20The%20Treatment%20Of%20High%20Cholesterol%20In%20Patients%20From%20Thailand
Description
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Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand

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