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NCT03154359 · ClinicalTrials.gov registry record
Atomoxetine PBPK-PD Clinical Study
A clinical trial, sponsored by Children's Mercy Hospital Kansas City.
- Completed
- Registry status
- 51
- Enrollment target
NCT03154359: Completed study, sponsored by Children's Mercy Hospital Kansas City.
NCT03154359 is a clinical trial that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03154359 has completed, sponsored by Children's Mercy Hospital Kansas City.
- COMPLETED
- Registry status
- 51 participants
- Enrollment target
Study Summary
The primary aims of this study focus on characterizing the relationship between atomoxetine exposure and clinical outcomes, as assessed by standardized measures. We will also simultaneously monitor side effect of atomoxetine, another measure of clinical outcomes, and categorize study participants on their ability to tolerate atomoxetine.
Primary Outcome
Classification of participants as "responders" versus "non-responders" is based on percent reduction in total National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Scale (3rd edition) score from baseline. Participants with ≥40% reduction in total score from baseline are classified as responders. The scale assesses the presence and severity of 18 DSM-V criteria for attention deficit hyperactivity disorder (ADHD) symptoms. Symptoms are rated on a 4-point Likert-type s
Interventions
- DRUG Atomoxetine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-12-12 |
| Est. Completion | 2022-06-16 |
What the finished NCT03154359 record still lists
NCT03154359 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Atomoxetine Hydrochloride is the first listed.
NCT03154359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03154359 about?
NCT03154359 is a clinical study titled "Atomoxetine PBPK-PD Clinical Study". The primary aims of this study focus on characterizing the relationship between atomoxetine exposure and clinical outcomes, as assessed by standardized measures. We will also simultaneously monitor side effect of atomoxetine, another measure of clinical outcomes, and categorize study participants on...
What is the current status of trial NCT03154359?
This trial is currently completed. The enrollment target is 51 participants. The study started on 2017-12-12. Estimated completion is 2022-06-16.
What interventions are being tested in trial NCT03154359?
The interventions under investigation include: Atomoxetine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03154359?
This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.
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