Safety Study of Atomoxetine and Cerebrovascular Outcomes

ADHD Clinical Trial

Official title:

Atomoxetine and Cerebrovascular Outcomes in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634439
• Other study ID #: 12414
• Secondary ID: B4Z-MC-B014
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: September 14, 2009
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72000
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• ADHD
• Cerebrovascular Accident
• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Drug:
• atomoxetine

• Stimulants
Methylphenidate, amphetamines (including Adderall and mixed salts)

Other:
• No intervention (general population)

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	i3 Drug Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular Accident (CVA)		January 2003 - June 2007	Yes
Primary	Transient Ischemic Attack (TIA)		January 2003 - June 2007	Yes

External Links

•   Lilly Clinical Trial Registry