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| Sponsors and Collaborators: |
Eli Lilly and Company i3 Drug Safety |
|---|---|
| Information provided by: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00634439 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Accident Transient Ischemic Attack ADHD |
Drug: atomoxetine Drug: Stimulants Other: No intervention (general population) |
| Study Type: | Observational |
| Study Design: | Cohort, Retrospective |
| Official Title: | Atomoxetine and Cerebrovascular Outcomes in Adults |
| Estimated Enrollment: | 72000 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
All patients 18 years or older who received a first dispensing of atomoxetine during the time period of the study (January 1, 2003 through December 31, 2006) and had at least 6 months of continuous enrollment prior to first dispensing are included in the study cohort. Patients are excluded for presence of pre-existing arrhythmia and heart failure during the baseline period. The study entry date for this cohort is the date of first atomoxetine dispensing.
|
Drug: atomoxetine |
|
B
All patients 18 years or older who received a first dispensing of a stimulant medication (methylphenidate or mixed salts of amphetamine) during the time period of the study with no dispensing of the same drug in the prior 6 months and had at least 6 months of continuous enrollment prior to the first dispensing are identified. Patients are excluded for presence of pre-existing arrhythmia and heart failure during the baseline period. Patients who are matched to atomoxetine initiators using this propensity score method are retained and followed as one comparator cohort. The study entry date is the date of the first dispensing of a comparator ADHD medication.
|
Drug: Stimulants
Methylphenidate, amphetamines (including Adderall and mixed salts)
|
|
C
Patients with at least 6 months of continuous enrollment in the database, and without a history of arrhythmia or heart failure during the baseline period are sampled and frequency matched on age and gender to the atomoxetine cohort in a 2:1 ratio. Study entry dates are assigned so as to be similar to the distribution of study entry dates in the atomoxetine cohort. Patients identified and matched as initiators of atomoxetine or stimulant ADHD medications are not eligible for inclusion in this cohort
|
Other: No intervention (general population) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The source population is derived from the proprietary Ingenix RDM, with a cross-sectional population of approximately 12 million current health plan members across the US at the beginning of 2007 who have both medical and prescription benefit coverage.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| 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 | |
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
| Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
| Study ID Numbers: | 12414, B4Z-MC-B014 |
| Study First Received: | March 4, 2008 |
| Last Updated: | March 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00634439 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
cerebrovascular accident stroke transient ischemic attack TIA |
CVA attention deficit hyperactivity disorder ADHD |
|
Ischemic Attack, Transient Neurotransmitter Agents Adrenergic Agents Cerebral Infarction Adderall Stroke Vascular Diseases Atomoxetine Methylphenidate Central Nervous System Diseases |
Ischemia Brain Diseases Cerebrovascular Disorders Methamphetamine Attention Deficit Disorder with Hyperactivity Hyperkinesis Brain Ischemia Amphetamine Brain Infarction Infarction |
|
Ischemic Attack, Transient Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cerebral Infarction Adrenergic Uptake Inhibitors Physiological Effects of Drugs Stroke Nervous System Diseases |
Vascular Diseases Central Nervous System Diseases Atomoxetine Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Brain Ischemia Cardiovascular Diseases Brain Infarction |
