Long-Term, Open Label Atomoxetine Study

Official Title: “Long-Term, Open Label Safety Study of Atomoxetine Hydrochloride in Patients, 6 Years and Older With Attention-Deficit/Hyperactivity Disorder”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• 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.

Primary Measures

• Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study
  • Time Frame: Baseline through 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in BP
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Pulse
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Body Weight
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Height
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Change From Baseline to 5 Year Endpoint in Heart Rate
  • Time Frame: baseline, 5 years
    Safety Issue?: Yes
• Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)
  • Time Frame: baseline through 5 years
    Safety Issue?: Yes
• Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)
  • Time Frame: baseline through 5 years
    Safety Issue?: Yes
• Number of Participants With Abnormal Laboratory Analytes During the Study
  • Time Frame: baseline through 5 years
    Safety Issue?: Yes
• Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group
  • Time Frame: 1 year through 5 years
    Safety Issue?: Yes

Secondary Measures

• 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
  • Time Frame: baseline, 5 years
    Safety Issue?: No
• Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score
  • Time Frame: baseline, 5 years
    Safety Issue?: No
• Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores
  • Time Frame: baseline, 5 years
    Safety Issue?: No
• Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test
  • Time Frame: baseline, 5 years
    Safety Issue?: No

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00190684

Study ID Number: 4331

ClinicalTrials.gov Identifier: NCT00190684

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry