DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With 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); Methylphenidate 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 the study is to compare atomoxetine hydrochloride and methylphenidate hydrochloride in pediatric patients with ADHD.

Clinical Details

Official title: A Randomized, Double-Blind Comparison, Safety and Efficacy Trial of Atomoxetine Hydrochloride and Methylphenidate Hydrochloride in Pediatric Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Test the hypothesis that atomoxetine hydrochloride is non-inferior to methylphenidate hydrochloride in improving ADHD symptoms following an approximately 8-week period of double blind treatment as assessed by a comparison of response rates

Secondary outcome:

To compare the tolerability of atomoxetine and methylphenidate as assessed by treatment-emergent adverse events

To assess the comparability of the efficacy of atomoxetine and methylphenidate on the Conners' Parent Rating Scale-Revised: Short Form

To compare atomoxetine and methylphenidate on other secondary measures

Eligibility

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be at least 6 years of age and not more than 16 years of age at Visit 1

- Must meet DSM-IV criteria for ADHD

- Must be of normal intelligence (that is, without a general impairment of intelligence

and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an IQ test)

- Must be able to swallow capsules

- Must have laboratory results that show no significant abnormalities (significant

would include laboratory deviations requiring acute medical intervention or further medical evaluation) Exclusion Criteria:

- Weigh less than 20 kg or more than 60 kg at study entry

- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental

disorder

- Meet DSM-IV criteria for an anxiety disorder

- Have a history of any seizure disorder (other than febrile seizures)or prior ECG

abnormalities related to epilepsy, or subjects who have taken or are currently taking anti-convulsants for seizure control

- Have a history of severe allergies to more than 1 class of medications or multiple

adverse drug reactions,including a hypersensitivity to methylphenidate

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., Shanghai, China

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, 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., Mexico City, Mexico

Additional Information

Lilly Clinical Trial Registry

Starting date: December 2003
Last updated: June 11, 2007

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017