Phase 3 Completed N=1,553 Treatment

Long-Term, Open Label Atomoxetine Study

Attention Deficit Hyperactivity Disorder

Source: ClinicalTrials.gov NCT00190684 ↗

Enrolled (actual)

1,553

Serious AEs

5.9%

Results posted

Jan 2011

Primary outcomePrimary: Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study — 228; 92; 19; 39 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study	228; 92; 19; 39; 7; 9	—
PRIMARY Change From Baseline to 5 Year Endpoint in BP	4.7; 1.3	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Pulse	-1.5	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Body Weight	11.0	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Height	10.9	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Weight, Height, and Body Mass Index (BMI) Percentile Stratified by Baseline Quartile	18.93; 14.90; -1.33; -6.68; 12.06; 9.53	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Electrocardiogram (ECG)	27.2; 2.6; -1.7; -0.2; 0.5	<0.001 sig
PRIMARY Change From Baseline to 5 Year Endpoint in Heart Rate	-2.5	<0.001 sig
PRIMARY Number of Patients Meeting Committee for Proprietary Medicinal Products (CPMP) Categorical QTc Interval Criteria Part I (Numerical Increase)	68; 2; 0; 50; 2; 0	—
PRIMARY Number of Patients Meeting CPMP Categorical QTc Interval Criteria Part II (Interpretation at Baseline and Endpoint)	1069; 156; 11; 180; 49; 6	—
PRIMARY Number of Participants With Abnormal Laboratory Analytes During the Study	0; 27; 2; 38; 0; 57	—
PRIMARY Number of Participants in Each Tanner Stage (Pubic Hair) by Age Group	2; 2; 2; 1; 0; 4	—
SECONDARY 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	3.5; 2.6; 0.9	p<0.001 sig
SECONDARY Change From Baseline to 5 Year Endpoint in Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S) Score	0.523	<0.001 sig
SECONDARY Change From Baseline to 5 Year Endpoint in Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Subscale Scores	2.411; 1.500; 0.325; 1.357	<0.001 sig
SECONDARY Change From Baseline to 5 Year Endpoint in the Stroop Word Color Test	—	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00190684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.