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NCT00634439 · ClinicalTrials.gov registry record
Safety Study of Atomoxetine and Cerebrovascular Outcomes
A clinical trial, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- 72,000
- Enrollment target
NCT00634439 is a clinical trial that has completed, run by Eli Lilly and Company. The registered enrollment target is 72,000 participants.
The verdict
NCT00634439 has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- 72,000 participants
- Enrollment target
Study 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.
Interventions
- DRUG atomoxetine
- DRUG Stimulants
- OTHER No intervention (general population)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72,000 participants |
| Start Date | 2008-01 |
| Est. Completion | 2008-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00634439
The ClinicalTrials.gov registry entry for NCT00634439 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 72,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which atomoxetine is the first listed.
NCT00634439 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00634439 about?
NCT00634439 is a clinical study titled "Safety Study of Atomoxetine and Cerebrovascular Outcomes". 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 wi...
What is the current status of trial NCT00634439?
This trial is currently completed. The enrollment target is 72,000 participants. The study started on 2008-01. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00634439?
The interventions under investigation include: atomoxetine (DRUG), Stimulants (DRUG), No intervention (general population) (OTHER).
Who is sponsoring clinical trial NCT00634439?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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