NCT00447278|CompletedPhase 3Results

A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

ADHD LIFE

A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

11576B4Z-EW-LYDY

Study Type

interventional

Target

399

Locations

9 countries

Sites

Timeline

RegisteredMar 2007

StartedMar 2007

CompletionJul 2009

Brief Summary

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

399

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2007

Geographic Reach

9 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

March 1, 2007

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed

10 months until next milestone

Results Posted

Study results publicly available

April 20, 2010

Completed

Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

2 years

First QC Date

March 12, 2007

Results QC Date

February 24, 2010

Last Update Submit

April 22, 2010

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.
Baseline, 6 months

Secondary Outcomes (8)

Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
Baseline, 4 months, 12 months
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
Baseline, 4 months, 6 months, 12 months
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
Baseline, 4 months, 6 months, 12 months
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
Baseline, 4 months, 6 months, 12 months
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
Baseline, 4 months, 6 months, 12 months
+3 more secondary outcomes

Study Arms (2)

Atomoxetine

EXPERIMENTAL

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

Drug: Atomoxetine

OEST

ACTIVE COMPARATOR

Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Drug: Other standard therapy for ADHD

Interventions

AtomoxetineDRUG

0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

Also known as: LY139603, Strattera

Atomoxetine

Other standard therapy for ADHDDRUG

Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

OEST

Eligibility Criteria

Age6 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

to 16 years old
Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
Pharmacological naïve
Normal intelligence as assessed by investigator
Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

You may not qualify if:

History of bipolar disorder, any history of psychosis or autism spectrum disorder
History of any seizure disorder
Significant prior or current medical conditions
History of alcohol or drug abuse within the past 3 months
Patients who are taking concurrently any of the excluded medications in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (35)

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.

Brussels, 1200, Belgium

Location

Hoboken, 2660, Belgium

Location

Leuven, 3000, Belgium

Location

Amiens, 80084, France

Location

Bordeaux, 33076, France

Location

Lyon, 69395, France

Location

Montpellier, 34 295, France

Location

Paris, 75019, France

Location

Toulouse, 31059, France

Location

Tours, 37044, France

Location

Westside, Galway, Ireland

Location

Dublin, Ireland

Location

Messina, 98125, Italy

Location

Napoli, 80131, Italy

Location

S.Vito Tagliamento, 37078, Italy

Location

San Donà di Piave, 30027, Italy

Location

Insurgentes Cuicuilco, 04530, Mexico

Location

Mexico City, 06720, Mexico

Location

Roma Sur, 06760, Mexico

Location

Bergen, N-5021, Norway

Location

Fredrikstad, 1606, Norway

Location

Alicante, 03114, Spain

Location

Barcelona, 08035, Spain

Location

Donostia / San Sebastian, 20009, Spain

Location

Espluges de Llobregat, 08950, Spain

Location

Palma de Mallorca, 07198, Spain

Location

Pamplona, 31008, Spain

Location

Sabadell, 08208, Spain

Location

Valencia, 46010, Spain

Location

Adana, Turkey (Türkiye)

Location

Ankara, 06100, Turkey (Türkiye)

Location

Izmir, 35340, Turkey (Türkiye)

Location

Basildon, Essex, SS15 5NL, United Kingdom

Location

Wigan, Lancashire, WN2 2JA, United Kingdom

Location

Sheffield, South Yorkshire, S10 5DD, United Kingdom

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 14, 2007

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

July 1, 2009

Last Updated

April 27, 2010

Results First Posted

April 20, 2010

Record last verified: 2010-04

Locations

IT(4)IE(2)BE(3)GB(3)TU(3)NO(2)ES(8)FR(7)ME(3)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Atomoxetine

OEST

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations