Safety Study of Atomoxetine and Cerebrovascular Outcomes
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebrovascular Accident; Transient Ischemic Attack; ADHD
Intervention: atomoxetine (Drug); Stimulants (Drug); No intervention (general population) (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
Using a proprietary insurance health claims database, Eli Lilly and Company has contracted
with an external party to conduct a retrospective cohort study of health claims for the time
period from 1 January 2003 through 31 December 2006 (with follow-up of patients through 30
June 2007). This study will evaluate the potential association between atomoxetine and
cerebrovascular events. In this study, the incidence of selected cerebrovascular outcomes as
represented in health claims data among adult patients who initiate therapy with atomoxetine
will be estimated. In particular the study will focus on cerebrovascular accident (CVA) and
transient ischemic attack (TIA) as the outcomes of interest. The incidence for each outcome
among atomoxetine initiators will then be compared to the incidence in a cohort of similar
patients who initiate stimulant treatment and an age and gender-matched general population
cohort. The atomoxetine and stimulant-initiating cohorts will be matched on a broad variety
of variables, including age, gender, diagnoses, medication use, and healthcare utilization
through the use of propensity score matching in order to minimize the influence of
confounding by indication. The analysis will include the cohorts (atomoxetine and stimulant
initiators) from a previous completed study with increased follow-up time (1 January 2003
through 30 June 2007) and accrue new atomoxetine and stimulant ADHD medication initiators
over a 2 year period, so that the study will represent initiators between January 1, 2003 and
December 31, 2006 with follow-up through June 30, 2007.
Clinical Details
Official title: Atomoxetine and Cerebrovascular Outcomes in Adults
Study design: Cohort, Retrospective
Primary outcome: Cerebrovascular Accident (CVA)Transient Ischemic Attack (TIA)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- patients 18 years or older
- received dispensing of one of the study medications during the time period of the study (January 1, 2003 - December 31, 2006)
- 6 months of continuous enrollment prior to first dispensing
Exclusion Criteria:
- presence of pre-existing arrhythmia and heart failure during the baseline period
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Indianapolis, Indiana, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: January 2008
Ending date: June 2008
Last updated: March 12, 2008
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