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

NCT00647543

Last updated date
Study Location
Pfizer Investigational Site
Bangkok, , 10400, Thailand
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Dyslipidemias
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Use of other lipid lowering agents (6-week washout period)


- Uncontrolled high blood pressure


- Impaired liver function

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Advanced Information
Descriptive Information
Brief Title  ICMJE Atorvastatin Study For The Treatment Of High Cholesterol In Patients From Thailand
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the efficacy of atorvastatin in lowering cholesterol on patients from Thailand with high cholesterol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemias
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: High Risk
    Intervention: Drug: Atorvastatin
  • Experimental: Low Risk
    Intervention: Drug: Atorvastatin
  • Experimental: Medium Risk
    Intervention: Drug: Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2008)
242
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647543
Other Study ID Numbers  ICMJE A2581111
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP