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A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Antwerpen, , 2018 Belgium
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
30-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Completion of base study

- Dyslipidemia and at high risk of CHD

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

- Impaired liver function

- Gastrointestinal disease that could limit drug absorption

NCT00644709
Pfizer
Completed
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)

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Descriptive Information
Brief Title  ICMJE A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
Official Title  ICMJE A Multicenter, Open-Label Extension Study Of High-Risk Hyperlipidemic Patients Treated With An Atorvastatin Starting Dose Adapted To Their Baseline LDL-C Level
Brief SummaryA study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dyslipidemias
Intervention  ICMJE Drug: Atorvastatin
Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.
Study Arms  ICMJE Experimental: Arm A
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)
196
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of base study
  • Dyslipidemia and at high risk of CHD

Exclusion Criteria:

  • Impaired liver function
  • Gastrointestinal disease that could limit drug absorption
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 30 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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644709
Other Study ID Numbers  ICMJE A2581112
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 DateMarch 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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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[email protected]

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