NCT00190736
Completed
Phase 4
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition
ConditionsADHD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- Eli Lilly and Company
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and Female patients with ADHD ages 18-
- •Patient must have ADHD symptoms that cause problem(s) in the home setting.
Exclusion Criteria
- •Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication.
- •Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1
Outcomes
Primary Outcomes
Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults.
Secondary Outcomes
- Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults.
Study Sites (1)
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