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Atomoxetine PBPK-PD Clinical Study

NCT03154359 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2023-08-08

Study results available
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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.

Conditions

  • ADHD

Interventions

DRUG

Atomoxetine Hydrochloride

Atomoxetine dose adjusted to achieve pre-defined concentration

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • James S Leeder, PharmD, PhD · Children's Mercy Hospital Kansas City

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-12
Primary Completion
2022-06-01
Completion
2022-06-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154359 on ClinicalTrials.gov