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Cardiovascular Events Based On Statin Initiation In The Elderly

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NCT01304641

Last updated on November 19, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular, Dyslipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- ≥ 1 fill for atorvastatin or simvastatin (not including combination therapy) between
01 July 2006 and 30 November 2008

- Age ≥ 65 years as of the year of index date

- Continuous enrollment with medical and pharmacy benefits during the analytic period

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

- 1 or more fills for a statin or other dyslipidemia medication in the 12-month
pre-index period

- A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the
12-month pre-index period

- Patients with evidence of a cardiovascular event in the 12-month pre-index period.

- Patients who received both atorvastatin and simvastatin on the index date

- Patients with unknown gender or region

- Patients who received dyslipidemia medications other than the index drug within 1
months (30 days) following the index date

NCT01304641
Pfizer
Completed
Cardiovascular Events Based On Statin Initiation In The Elderly

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Descriptive Information
Brief TitleCardiovascular Events Based On Statin Initiation In The Elderly
Official TitleComparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin
Brief SummaryThe purpose of this study is to compare rates and risk of primary cardiovascular events among elderly patients newly initiating therapy with atorvastatin or simvastatin. The specific objectives for this project are to: 1) examine the demographic and clinical characteristics of the elderly patients in whom atorvastatin or simvastatin was newly initiated; and 2) compare cardiovascular event rates in elderly patients in whom atorvastatin or simvastatin was newly initiated.
Detailed DescriptionAll subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThis study included commercial health plan members and Medicare Advantage Part D enrollees ages 65 years and older with a prescription for atorvastatin or simvastatin filled between 01 July 2006 and 30 November 2008 (subject identification period). The first observed atorvastatin or simvastatin fill during the subject identification period was defined as the index drug and the fill date was defined as the index date. A 12-month period prior to the index date (defined as the pre-index period) was used for identification of comorbid exclusionary conditions. The 12-month period prior to index date was also used for assessment of pre-index patient characteristics. Patients were observed for a minimum of 3 months (following index date) until the earlier of either 1) disenrollment from the health plan or 2) 28 February 2009 (post-index period). The pre- and post-index periods in combination were defined as the analytic period.
Condition
  • Cardiovascular
  • Dyslipidemia
Intervention
  • Other: Atorvastatin Initiators
    Retrospective database analysis no intervention performed.
  • Other: Simvastatin Initiators
    Retrospective database analysis no intervention performed.
Study Groups/Cohorts
  • Atorvastatin Initiators
    Intervention: Other: Atorvastatin Initiators
  • Simvastatin Initiators
    Intervention: Other: Simvastatin Initiators
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 StatusCompleted
Actual Enrollment
 (submitted: March 8, 2012)		31603
Original Actual Enrollment
 (submitted: February 24, 2011)		31602
Actual Study Completion DateFebruary 2011
Actual Primary Completion DateFebruary 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ? 1 fill for atorvastatin or simvastatin (not including combination therapy) between 01 July 2006 and 30 November 2008
  • Age ? 65 years as of the year of index date
  • Continuous enrollment with medical and pharmacy benefits during the analytic period

Exclusion Criteria:

  • 1 or more fills for a statin or other dyslipidemia medication in the 12-month pre-index period
  • A pharmacy fill for clopidogrel or nitrates (except concomitant hydralazine) in the 12-month pre-index period
  • Patients with evidence of a cardiovascular event in the 12-month pre-index period.
  • Patients who received both atorvastatin and simvastatin on the index date
  • Patients with unknown gender or region
  • Patients who received dyslipidemia medications other than the index drug within 1 months (30 days) following the index date
Sex/Gender
Sexes Eligible for Study:All
Ages65 Years and older   (Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01304641
Other Study ID NumbersA2581188
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2012

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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