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A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol

Last updated on October 10, 2019

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Study Location
Pfizer Investigational Site
Belo Horizonte, MG, Brazil
Contact
1-800-718-1021
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.
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- Patients with high cholesterol eligible for treatment with baseline LDL-C level of
less than or equal to 220 mg/dL

- Willingness to follow diet

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

- Triglycerides less than or equal to 400 mg/dL

- Hemoglobin A1c >10%

NCT00645151
Pfizer
Completed
A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol

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Descriptive Information
Brief Title  ICMJE A Study Of The Efficacy Of Atorvastatin In Lowering Cholesterol In Latin American Patients With High Cholesterol
Official Title  ICMJE A Multicenter, Eight-Week Treatment, Single Step Titration, Open-Label Study Assessing The Percentage Of Subjects Achieving Low Density Lipoprotein Cholesterol Target With Atorvastatin Starting Doses Of 10 Mg, 20 Mg, 40 Mg, And 80 Mg (Latin American Atorvastatin ATGOAL Study)
Brief SummaryThe purpose of this study is to determine the percentage of patients who would reach a cholesterol goal after atorvastatin treatment.
Detailed DescriptionNot 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 calcium 10, 20, 40, or 80 mg tablets (dose dependent on individual risk factors and baseline LDL-C level) once daily for 4 weeks. After 4 weeks of treatment, subjects who did not achieve the LDL-C target goal were up-titrated to 20, 40, or 80 mg and subjects who achieved their LDL-target goal remained on the same dose for the following 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 25, 2008)
512
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with high cholesterol eligible for treatment with baseline LDL-C level of less than or equal to 220 mg/dL
  • Willingness to follow diet

Exclusion Criteria:

  • Triglycerides less than or equal to 400 mg/dL
  • Hemoglobin A1c >10%
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 Brazil,   Chile,   Colombia,   Ecuador,   Guatemala,   Mexico,   Panama,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645151
Other Study ID Numbers  ICMJE A2581104
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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