NCT00190736CompletedPhase 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
Eli Lilly and Company18 sites in 1 country440 target enrollmentStarted: September 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 440
- Locations
- 18
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 54 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Investigators
Study Sites (18)
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