NCT00190684

Brief Summary

To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term). Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,553

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_3

Geographic Reach
14 countries

100 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

Study Start

First participant enrolled

August 1, 2000

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 17, 2011

Completed
Last Updated

January 17, 2011

Status Verified

December 1, 2010

Enrollment Period

9.2 years

First QC Date

September 12, 2005

Results QC Date

October 1, 2010

Last Update Submit

December 15, 2010

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (12)

  • Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study

    Vital signs were assesed categorically using the term high for BP, high and low for pulse and temperature, or decreased for weight. For BP, high was an increase to a value above the 95th percentile of the National Institute of Health (NIH) values. For pulse, high was an increase of at least 25 beats per minute to at least 110, and low was a decrease of at least 20 beats per minute to at most 65 beats per minute. For temperature, high was an increase of at least 1 to 37.7 and low was a decrease of at least 1.3 to at most 35.6. Decrease in weight was marked by a reduction of at least 3.5%.

    Baseline through 5 years

  • Change From Baseline to 5 Year Endpoint in BP

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Pulse

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Body Weight

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Height

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile

    Patients were assessed for changes in weight, height, and BMI. BMI is an estimate of body fat based on body weight divided by height squared.

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)

    Patients were assessed for changes in ECG. The RR interval is the time duration between two consecutive R waves of the ECG. The QRS interval is the beginning of Q to the end of the S wave. The QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula.QTdat is the QT interval using a data specific correction method for children.

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Heart Rate

    Patients were assessed for changes in heart rate using electrocardiogram.

    baseline, 5 years

  • Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)

    QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children.

    baseline through 5 years

  • Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)

    QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate. A corrected QT interval (QTc) has been corrected in order to aid interpretation. QTbz is the QT interval using Bazett's correction formula. QTfr is the QT interval using Fridericia's correction formula. QTdat is the QT interval using a data specific correction method for children. For Males: Normal is \<430 ms, Borderline is \>=430 ms and \<450 ms, Prolonged is \>=450 ms. For Females: Normal is \<450 ms, Borderline is \>=450 ms and \<470 ms, Prolonged is \>=470 ms.

    baseline through 5 years

  • Number of Participants With Abnormal Laboratory Analytes During the Study

    Standard reference ranges from Covance Laboratories were used in the determination of abnormal high and low values based on age and gender, where appropriate. Aspartate aminotransferase (AST); serum glutamic oxaloacetic transaminase (SGOT); units/liter (U/L); alanine aminotransferase (ALT); serum glutamic pyruvic transaminase (SGPT); millimoles/liter (mmol/L); grams/liter (g/L); micromoles/liter (umol/L); millimoles/liter-iron (mmol/L-Fe); trillion/liter (TI/L)or 10\^12 units/liter; Giga/liter (GI/L)or 10\^9 units/liter; femtoliters (fL); urinalysis (UA)

    baseline through 5 years

  • Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group

    Tanner Stage: I: no pubic hair at all (prepubertal Dominic state) II: small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females) III: hair becomes more coarse and curly, and begins to extend laterally IV: adult-like hair quality, extending across pubis but sparing medial thighs V: hair extends to medial surface of the thighs Age Groups: 1. age\<11.0 (female) and age\<12 (male) 2. 11=\<age\<12 (female) or 12\<=age\<13 (male) 3. 12=\<age\<15 (female) or 13=\<age\<15 (male) 4. age\>=15 (female and male)

    1 year through 5 years

Secondary Outcomes (4)

  • 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

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores

    baseline, 5 years

  • Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test

    baseline, 5 years

Study Arms (1)

Atomoxetine

EXPERIMENTAL

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.

Drug: atomoxetine

Interventions

atomoxetineDRUG

0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years

Also known as: LY139603, Strattera
Atomoxetine

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (100)

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Birmingham, Alabama, 35233, United States

Location

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Phoenix, Arizona, 85016, United States

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El Centro, California, 92243, United States

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Irvine, California, 92618, United States

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Lafayette, California, 94549, United States

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Los Angeles, California, 90095, United States

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San Diego, California, 92123, United States

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Spring Valley, California, 91978, United States

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Walnut Creek, California, 94596, United States

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Norwich, Connecticut, 06360, United States

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Boca Raton, Florida, 33433, United States

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Gainsville, Florida, 32607, United States

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Miami, Florida, 33173, United States

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Orlando, Florida, 32806, United States

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Tallahassee, Florida, 32308, United States

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West Palm Beach, Florida, 33407, United States

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Boise, Idaho, 83704, United States

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Northbrook, Illinois, 60062, United States

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Indianapolis, Indiana, 46202, United States

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Lafayette, Indiana, 47904, United States

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Iowa City, Iowa, 52242, United States

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Bardstown, Kentucky, 40004, United States

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Lexington, Kentucky, 40509, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21287, United States

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Cambridge, Massachusetts, 02138, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48201, United States

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Kalamazoo, Michigan, 49008, United States

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Troy, Michigan, 48085, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68198, United States

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Cherry Hill, New Jersey, 08034, United States

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Clementon, New Jersey, 08021, United States

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Moorestown, New Jersey, 08057, United States

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Piscataway, New Jersey, 08855, United States

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Manhasset, New York, 11030, United States

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New Hyde Park, New York, 11042, United States

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New York, New York, 10016, United States

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Rochester, New York, 14620, United States

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Stony Brook, New York, 11794, United States

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Chapel Hill, North Carolina, 27514, United States

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Charlotte, North Carolina, 28211, United States

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Durham, North Carolina, 27705, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Oklahoma City, Oklahoma, 73103, United States

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Portland, Oregon, 97239, United States

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Hershey, Pennsylvania, 17033, United States

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Media, Pennsylvania, 19063, United States

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Philadelphia, Pennsylvania, 19129, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Rydal, Pennsylvania, 19046, United States

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Providence, Rhode Island, 02903, United States

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Nashville, Tennessee, 37212, United States

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Dallas, Texas, 75235, United States

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Galveston, Texas, 77555, United States

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Lake Jackson, Texas, 77566, United States

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Salt Lake City, Utah, 84107, United States

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Fairfax, Virginia, 22031, United States

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Herndon, Virginia, 20170, United States

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Midlothian, Virginia, 23112, United States

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Norfolk, Virginia, 23510, United States

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Richmond, Virginia, 23298, United States

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Vienna, Virginia, 22180, United States

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Spokane, Washington, 99220, United States

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Marshfield, Wisconsin, 54449, United States

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Middleton, Wisconsin, 53562, United States

Location

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Milwaukee, Wisconsin, 53226, United States

Location

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Wallsend, New South Wales, 2287, Australia

Location

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South Brisbane, Queensland, 4101, Australia

Location

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West Perth, Western Australia, 6005, Australia

Location

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Antwerp, 2020, Belgium

Location

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Leuven, 3000, Belgium

Location

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Edmonton, Alberta, T5G0B7, Canada

Location

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Halifax, Nova Scotia, B3J3G9, Canada

Location

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Toronto, Ontario, M5G1X8, Canada

Location

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Québec, Quebec, G1R2W8, Canada

Location

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Bordeaux, 33076, France

Location

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Lyon, 69395, France

Location

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Paris, 75019, France

Location

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Paris, 75571, France

Location

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Heiligenstadt/Ofr, D-91332, Germany

Location

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Mannheim, 68159, Germany

Location

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Holon, 22100, Israel

Location

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Ness Ziona, 70450, Israel

Location

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Cagliari, 09124, Italy

Location

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Pisa, 50018, Italy

Location

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Groningen, 9713 GZ, Netherlands

Location

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Utrecht, 3584 CX, Netherlands

Location

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Oslo, 0319, Norway

Location

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Rio Piedras, 00936, Puerto Rico

Location

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San Juan, 00936, Puerto Rico

Location

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Benmore, Sandown, 2010, South Africa

Location

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Garsfontein, 0042, South Africa

Location

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Panorama, 7500, South Africa

Location

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Gothenburg, 41118, Sweden

Location

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Glasgow, Scotland, G3 8SJ, United Kingdom

Location

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Sheffield, South Yorkshire, S10 5DD, United Kingdom

Location

Related Publications (1)

  • Michelson D, Read HA, Ruff DD, Witcher J, Zhang S, McCracken J. CYP2D6 and clinical response to atomoxetine in children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2007 Feb;46(2):242-51. doi: 10.1097/01.chi.0000246056.83791.b6.

    PMID: 17242628DERIVED

Related Links

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
800-545-5979

Study Officials

  • 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)

    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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

August 1, 2000

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 17, 2011

Results First Posted

January 17, 2011

Record last verified: 2010-12

Locations

BE(2)IL(2)NL(2)US(70)FR(4)CA(4)DE(2)PR(2)ZA(3)NO(1)SE(1)AU(3)IT(2)GB(2)