Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00191035

First received: September 12, 2005

Last updated: December 12, 2006

Last verified: December 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 12, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00191035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

Official Title ^ICMJE

Maintenance of Benefit After 8-Week and 52-Week Treatment With Atomoxetine Hydrochloride in Adolescents With ADHD

Brief Summary

The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Attention-Deficit/Hyperactivity Disorder

Intervention ^ICMJE

Drug: Atomoxetine

Study Arm (s)

Not Provided

Publications *

Wietecha LA, Williams DW, Herbert M, Melmed RD, Greenbaum M, Schuh K. Atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):719-30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

520

Completion Date

November 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients must have ADHD.
Must be 13-16 years of age.
Must be able to swallow capsules.
Expected to achieve score of 70 or more on IQ test
Willing and reliable to keep appts. for clinic visits and test

Exclusion Criteria:

Treatment within last 30 days with a drug that has not received regulatory approval for any indication.
Patients who weigh less than 40 kg or greater than 70 kg.
Patients with documented history of Bipolar I or II disorder, or psychosis
Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder

Gender

Both

Ages

13 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00191035

Other Study ID Numbers ^ICMJE

7974, B4Z-US-LYCD

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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