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NCT00190775 · ClinicalTrials.gov registry record · Phase 4
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 4 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 502
- Enrollment target
NCT00190775: Completed Phase 4 study, sponsored by Eli Lilly and Company.
NCT00190775 is a Phase 4 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 502 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00190775, a Phase 4 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 502 participants
- Enrollment target
Study Summary
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 12 and 24 weeks of blinded treatment.
Primary Outcome
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more im
Interventions
- DRUG Placebo
- DRUG Atomoxetine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-10 |
| Phase | Phase 4 |
What the finished NCT00190775 record still lists
NCT00190775 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00190775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00190775 about?
NCT00190775 is a clinical study titled "A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)". This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (ADHD) who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrat...
What is the current status of trial NCT00190775?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 502 participants. The study started on 2004-09. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00190775?
The interventions under investigation include: Placebo (DRUG), Atomoxetine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00190775?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00190775's enrollment target sits among peer trials
502 164th of 2000 higher than 1,837 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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