Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

NCT ID: NCT00191035

Last Updated: 2006-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Attention-Deficit/Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Atomoxetine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Pasadena, California, United States

Site Status

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Rolling Hills Estates, California, United States

Site Status

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Spring Valley, California, United States

Site Status

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Norwich, Connecticut, United States

Site Status

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West Palm Beach, Florida, United States

Site Status

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Atlanta, Georgia, United States

Site Status

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Libertyville, Illinois, United States

Site Status

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Rochester Hills, Michigan, United States

Site Status

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St Louis, Missouri, United States

Site Status

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Las Vegas, Nevada, United States

Site Status

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Clementon, New Jersey, United States

Site Status

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Morristown, New Jersey, United States

Site Status

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New York, New York, United States

Site Status

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Olean, New York, United States

Site Status

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Chapel Hill, North Carolina, United States

Site Status

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Columbus, Ohio, United States

Site Status

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Oklahoma City, Oklahoma, United States

Site Status

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Portland, Oregon, United States

Site Status

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Philadelphia, Pennsylvania, United States

Site Status

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Memphis, Tennessee, United States

Site Status

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Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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. doi: 10.1089/cap.2008.074.

Reference Type DERIVED
PMID: 20035590 (View on PubMed)

Other Identifiers

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B4Z-US-LYCD

Identifier Type: -

Identifier Source: secondary_id

7974

Identifier Type: -

Identifier Source: org_study_id