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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.

Official Title
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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

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk<br> | Drug: Atorvastatin<br>* 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.<br>|
| Experimental: Low Risk<br> | Drug: Atorvastatin<br>* 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.<br>|
| Experimental: Medium Risk<br> | Drug: Atorvastatin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target |  | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change and percent change from baseline in total cholesterol |  | Weeks 2, 4, and 8 | 
| Change and percent change from baseline in triglycerides |  | Weeks 2, 4, and 8 |