Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
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
1 other identifier
interventional
242
1 country
3
Brief Summary
The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2003
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedFebruary 18, 2021
February 1, 2021
March 26, 2008
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target
Week 8
Secondary Outcomes (7)
Adverse events and laboratory test changes
Weeks 2, 4, and 8
Percentage of patients who achieved LDL-C target
Weeks 2 and 4, and Week 8 with 1 step titration
Change and percent change from baseline in LDL-C
Weeks 2, 4, and 8
Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Weeks 2, 4, and 8
Change and percent change from baseline in LDL/HDL ratio
Weeks 2, 4, and 8
- +2 more secondary outcomes
Study Arms (3)
High Risk
EXPERIMENTALLow Risk
EXPERIMENTALMedium Risk
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of other lipid lowering agents (6-week washout period)
- Uncontrolled high blood pressure
- Impaired liver function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Pfizer Investigational Site
Bangkok, 10400, Thailand
Pfizer Investigational Site
Bangkok, 10700, Thailand
Pfizer Investigational Site
Chiang Mai, 50200, Thailand
Pfizer Investigational Site
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2008
First Posted
March 31, 2008
Study Start
August 1, 2003
Study Completion
April 1, 2004
Last Updated
February 18, 2021
Record last verified: 2021-02