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Atomoxetine to Treat Korean Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Atomoxetine Hydrochloride (Drug); Atomoxetine hydrochloride (Drug); Atomoxetine hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Details

Official title: A Phase 3b, Randomized, Open-Label Assessment of Response to Various Doses of Atomoxetine Hydrochloride in Korean Pediatric Outpatients With Attention-Deficit/Hyperactivity Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline to Day 42 Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score

Secondary outcome:

Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint

Change From Baseline in Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Score at Days 7, 14, 42, and Last Observation Carried Forward Endpoint

Adverse Events Leading to Discontinuation

Incidence of Completion of the Columbia Suicide-Severity Rating Scale, Suicide and Self-Harm Summary

Heart Rate Change From Baseline to Day 42 Endpoint

Temperature Change From Baseline to Day 42 Endpoint

Blood Pressure Change From Baseline to Day 42 Endpoint

Weight Change From Baseline to Day 42 Endpoint

Eligibility

Minimum age: 6 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients will be outpatients who are aged 6 to 18 years old at the initial screening

visit.

- Patients must have ADHD, based on the accepted criteria for that disease

- Patients must not have taken any medication used to treat ADHD for at least two weeks

prior to beginning study treatment; and at least one week prior to the study screening visit during which initial ADHD assessments were made

- Patients must be able to swallow capsules

- Patients and parents (or legal guardians) must be judged by the study investigator to

be reliable to keep appointments for clinic visits and all tests, including blood tests and any other required examinations Exclusion Criteria:

- Patients must not have received any treatment within the last 30 days with a drug

that has not been approved by their country's appropriate government agency

- Patients will not be included in the study if they have previously experienced any

unwanted effects or serious medical events during atomoxetine treatment

- Patients will not be included in the study if they are judged by the study

investigator to be at serious suicidal risk

- Patients will not be included in the study if they have cardiovascular disease or

other conditions that could be worsened by an increased heart rate or increased blood pressure

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bucheon 420-767, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., In Cheon 405-760, Korea, Republic of

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seoul 135-720, Korea, Republic of

Additional Information

Lilly Clinical Trial Registry

Starting date: November 2007
Last updated: January 19, 2010

Page last updated: August 23, 2015

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