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

Dyslipidemias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647543
• Other study ID #: A2581111
• Status: Completed
• Phase: Phase 4
• Start date: August 2003
• Est. completion date: April 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 of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• Atorvastatin
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.
• Atorvastatin
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.
• Atorvastatin
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.

Locations

Country	Name	City	State
	Pfizer Investigational Site
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Bangkok
Thailand	Pfizer Investigational Site	Chiang Mai

Sponsors (1)

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

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who achieved low-density lipoprotein cholesterol (LDL-C) target		Week 8
Secondary	Adverse events and laboratory test changes		Weeks 2, 4, and 8
Secondary	Percentage of patients who achieved LDL-C target		Weeks 2 and 4, and Week 8 with 1 step titration
Secondary	Change and percent change from baseline in LDL-C		Weeks 2, 4, and 8
Secondary	Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)		Weeks 2, 4, and 8
Secondary	Change and percent change from baseline in LDL/HDL ratio		Weeks 2, 4, and 8
Secondary	Change and percent change from baseline in total cholesterol		Weeks 2, 4, and 8
Secondary	Change and percent change from baseline in triglycerides		Weeks 2, 4, and 8

External Links

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