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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00190684




Registration number
NCT00190684
Ethics application status
Date submitted
12/09/2005
Date registered
19/09/2005
Date last updated
17/01/2011

Titles & IDs
Public title
Long-Term, Open Label Atomoxetine Study
Scientific title
Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder
Secondary ID [1] 0 0
B4Z-MC-LYAI
Secondary ID [2] 0 0
4331
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - atomoxetine

Experimental: Atomoxetine - Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted with be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.


Treatment: Drugs: atomoxetine
0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
Timepoint [1] 0 0
Baseline through 5 years
Primary outcome [2] 0 0
Change From Baseline to 5 Year Endpoint in BP
Timepoint [2] 0 0
baseline, 5 years
Primary outcome [3] 0 0
Change From Baseline to 5 Year Endpoint in Pulse
Timepoint [3] 0 0
baseline, 5 years
Primary outcome [4] 0 0
Change From Baseline to 5 Year Endpoint in Body Weight
Timepoint [4] 0 0
baseline, 5 years
Primary outcome [5] 0 0
Change From Baseline to 5 Year Endpoint in Height
Timepoint [5] 0 0
baseline, 5 years
Primary outcome [6] 0 0
Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
Timepoint [6] 0 0
baseline, 5 years
Primary outcome [7] 0 0
Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
Timepoint [7] 0 0
baseline, 5 years
Primary outcome [8] 0 0
Change From Baseline to 5 Year Endpoint in Heart Rate
Timepoint [8] 0 0
baseline, 5 years
Primary outcome [9] 0 0
Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
Timepoint [9] 0 0
baseline through 5 years
Primary outcome [10] 0 0
Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
Timepoint [10] 0 0
baseline through 5 years
Primary outcome [11] 0 0
Number of Participants With Abnormal Laboratory Analytes During the Study
Timepoint [11] 0 0
baseline through 5 years
Primary outcome [12] 0 0
Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
Timepoint [12] 0 0
1 year through 5 years
Secondary outcome [1] 0 0
Change From Baseline to 5 Year Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and Subscale Scores
Timepoint [1] 0 0
baseline, 5 years
Secondary outcome [2] 0 0
Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
Timepoint [2] 0 0
baseline, 5 years
Secondary outcome [3] 0 0
Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
Timepoint [3] 0 0
baseline, 5 years
Secondary outcome [4] 0 0
Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
Timepoint [4] 0 0
baseline, 5 years

Eligibility
Key inclusion criteria
* Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
* Must meet the study criteria for ADHD
* Must be willing to have blood drawn and to complete other test required for this study
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
* taking certain medicines that could interact with atomoxetine
* plan to move too far away from a doctor participating in this study in the next 5 years
* current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
1553
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
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. - Wallsend
Recruitment hospital [2] 0 0
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. - South Brisbane
Recruitment hospital [3] 0 0
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. - West Perth
Recruitment postcode(s) [1] 0 0
2287 - Wallsend
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Rhode Island
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin
Country [31] 0 0
Belgium
State/province [31] 0 0
Antwerpen
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
Nova Scotia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
France
State/province [37] 0 0
Bordeaux Cedex
Country [38] 0 0
France
State/province [38] 0 0
Lyon
Country [39] 0 0
France
State/province [39] 0 0
Paris Cedex 12
Country [40] 0 0
France
State/province [40] 0 0
Paris
Country [41] 0 0
Germany
State/province [41] 0 0
Heiligenstadt/Ofr
Country [42] 0 0
Germany
State/province [42] 0 0
Mannheim
Country [43] 0 0
Israel
State/province [43] 0 0
Holon
Country [44] 0 0
Israel
State/province [44] 0 0
Ness Ziona
Country [45] 0 0
Italy
State/province [45] 0 0
Cagliari
Country [46] 0 0
Italy
State/province [46] 0 0
Pisa
Country [47] 0 0
Netherlands
State/province [47] 0 0
Groningen
Country [48] 0 0
Netherlands
State/province [48] 0 0
Utrecht
Country [49] 0 0
Norway
State/province [49] 0 0
Oslo
Country [50] 0 0
Puerto Rico
State/province [50] 0 0
Rio Piedras
Country [51] 0 0
Puerto Rico
State/province [51] 0 0
San Juan
Country [52] 0 0
South Africa
State/province [52] 0 0
Sandown
Country [53] 0 0
South Africa
State/province [53] 0 0
Garsfontein
Country [54] 0 0
South Africa
State/province [54] 0 0
Panorama
Country [55] 0 0
Sweden
State/province [55] 0 0
Goteburg
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Scotland
Country [57] 0 0
United Kingdom
State/province [57] 0 0
South Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-619-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00190684