Cardiovascular Events Based On Statin Initiation In The Elderly
NCT01304641
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- ≥ 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Cardiovascular Events Based On Statin Initiation In The Elderly | |||
| Official Title | Comparison Of Cardiovascular Event Rates In Elderly Patients With Newly Initiated Atorvastatin Or Simvastatin | |||
| Brief Summary | The 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 Description | All subjects meeting sample definition, all inclusion criteria, and none of the exclusion criteria. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | This 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 |
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| Intervention |
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| Study Groups/Cohorts |
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| 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 | Completed | |||
| Actual Enrollment | 31603 | |||
| Original Actual Enrollment | 31602 | |||
| Actual Study Completion Date | February 2011 | |||
| Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 65 Years and older (Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT01304641 | |||
| Other Study ID Numbers | A2581188 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Pfizer | |||
| Verification Date | March 2012 | |||