Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00485459
First received: June 11, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Atomoxetine Hydrochloride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD
Secondary Outcome Measures:
- Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo
- Compare the reduction in school-related symptoms between atomoxetine and placebo
- Assess the safety and tolerability of once-daily dosing of atomoxetine
| Enrollment: | 106 |
| Study Start Date: | February 2004 |
| Study Completion Date: | November 2004 |
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
- Subjects must be aged 6 to 16 years
- Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
- Subjects must be able to swallow capsules
- Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Exclusion Criteria:
- Weigh less than 20 kg or more than 60 kg at study entry
- Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
- Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
- Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
- Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485459
Locations
| Taiwan | |
| 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 | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00485459 History of Changes |
| Other Study ID Numbers: | 8160, B4Z-TW-S010 |
| Study First Received: | June 11, 2007 |
| Last Updated: | June 11, 2007 |
| Health Authority: | United States: Food and Drug Administration Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Atomoxetine Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013