Cerebrovascular AccidentNCT00634439
Safety Study of Atomoxetine and Cerebrovascular Outcomes
An observational study of Cerebrovascular Accident and Transient Ischemic Attack, run by Eli Lilly and Company at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident, Transient Ischemic Attack, ADHD
- What is being tested?
- atomoxetine and Stimulants
- How many people
- 72,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- presence of pre-existing arrhythmia and heart failure during the baseline period
Trial locations and contacts
1 site in 1 country.
United States1 site
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
About this study
Official title: Atomoxetine and Cerebrovascular Outcomes in Adults
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.
- Conditions
- Cerebrovascular Accident, Transient Ischemic Attack, ADHD
- Being tested
- atomoxetine, Stimulants, No intervention (general population)
- Keywords
- cerebrovascular accident, stroke, transient ischemic attack, TIA, CVA, attention deficit hyperactivity disorder, ADHD
- Medical subject headings
- Stroke, Ischemic Attack, Transient, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atomoxetineDrug
Also called LY139603, Strattera
StimulantsDrug
Methylphenidate, amphetamines (including Adderall and mixed salts)
No intervention (general population)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Stimulants | |
| 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 Receives: Other: No intervention (general population) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular Accident (CVA)
Measured: January 2003 - June 2007
Transient Ischemic Attack (TIA)
Measured: January 2003 - June 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Drug Safety
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634439
- Sponsor's protocol ID
- 12414
- Other IDs
- B4Z-MC-B014
- Status last verified
- Sep 2009
- First submitted
- 4 Mar 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atomoxetine and Cerebrovascular Outcomes in Adults
- ClinicalTrials.gov ID
- NCT00634439
- Acronym / sponsor ID
- 12414
- Conditions
- Cerebrovascular Accident, Transient Ischemic Attack, ADHD
- Keywords
- cerebrovascular accident, stroke, transient ischemic attack, TIA, CVA, attention deficit hyperactivity disorder, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72,000 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- i3 Drug Safety
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: atomoxetineAll 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. |
| B | – | Drug: StimulantsAll 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. |
| C | – | Other: No intervention (general population)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- presence of pre-existing arrhythmia and heart failure during the baseline period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atomoxetineAlso: LY139603, Strattera | Drug | A |
| StimulantsMethylphenidate, amphetamines (including Adderall and mixed salts) | Drug | B |
| No intervention (general population) | Other | C |
Primary outcome
Cerebrovascular Accident (CVA)
Time frame: January 2003 - June 2007
Transient Ischemic Attack (TIA)
Time frame: January 2003 - June 2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9AM- 5PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Transient Ischemic Attack, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular Accident (CVA) (time frame: January 2003 - June 2007). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.