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Completed

NCT Number: NCT00647543

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

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

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

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 outcomes

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

    Time frame: Week 8

Secondary outcomes

  1. Adverse events and laboratory test changes

    Time frame: Weeks 2, 4, and 8

  2. Percentage of patients who achieved LDL-C target

    Time frame: Weeks 2 and 4, and Week 8 with 1 step titration

  3. Change and percent change from baseline in LDL-C

    Time frame: Weeks 2, 4, and 8

  4. Change and percent change from baseline in high-density lipoprotein cholesterol (HDL-C)

    Time frame: Weeks 2, 4, and 8

  5. Change and percent change from baseline in LDL/HDL ratio

    Time frame: Weeks 2, 4, and 8

  6. Change and percent change from baseline in total cholesterol

    Time frame: Weeks 2, 4, and 8

  7. Change and percent change from baseline in triglycerides

    Time frame: Weeks 2, 4, and 8

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 31, 2008
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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