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A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

Last updated on November 11, 2019

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Study Location
Pfizer Investigational Site
Alabaster, Alabama, 35007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Disease, Cerebrovascular Accident, Coronary Heart Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Men and women age 35-75 who have evident CHD

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

Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary
hyperlipidemia

NCT00327691
Pfizer
Completed
A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

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Descriptive Information
Brief Title  ICMJE A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels
Official Title  ICMJE The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD
Brief SummaryThe primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Cerebrovascular Accident
  • Coronary Heart Disease
Intervention  ICMJE Drug: Atorvastatin
Study Arms  ICMJE Not Provided
Publications *


*   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
Enrollment  ICMJE
 (submitted: May 16, 2006)
8600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2004
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Men and women age 35-75 who have evident CHD

Exclusion Criteria:

Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years to 75 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 Australia,   Austria,   Belgium,   Canada,   France,   Germany,   Ireland,   Italy,   Netherlands,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00327691
Other Study ID Numbers  ICMJE 0981-117
A2581136
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2007

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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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