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Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Atomoxetine Hydrochloride (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.

Clinical Details

Official title: An Open-Label, Multicenter, Pilot Study of the Safety and Efficacy of Transitioning From a Stimulant Medication to Atomoxetine in Pediatric and Adolescent Outpatients With DSM-IV Attention-Deficit/Hyperactivity Disorder (ADHD)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assess the change in ADHD symptoms when switching from stimulant medication to atomoxetine among patients who cannot tolerate or do not respond to stimulants and require a medication change

Secondary outcome:

Assess whether there are statistically significant differences in ADHD symptom measures after a patient changes from a stimulant medication to atomoxetine

Assess the safety and tolerability of atomoxetine alone compared with stimulant medications alone and during the time of switch (stimulant plus atomoxetine) as assessed by AEs elicited during open-ended questioning.

Compare atomoxetine and stimulant medications on other secondary measures, including parent preference

Assess whether there is a significant change in problem behaviors related to ADHD after switching from stimulant medication to atomoxetine

Assess the change in inattentive and hyperactive symptoms among these same patients

Eligibility

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients must be at least 6 years of age and not yet be 18 years of age at the

completion of visit 6

- Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)

- Patients must have laboratory results showing no significant abnormalities

(significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)

- Patients must be of normal intelligence as assessed by the investigator (that is,

without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on a IQ test)

- Patients must be able to swallow capsules

Exclusion Criteria:

- Patients who weigh less than 22 kg or more than 70 kg at study entry

- Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a

pervasive developmental disorder

- Patients with a history of any seizure disorder (other than febrile seizures) or

prior EEG abnormalities related to epilepsy, or patients who have taken (or are currently taking) anticonvulsants for seizure control

- Patients with a history of severe allergies to more than one class of medication, or

multiple adverse drug reactions

- Patients who have glaucoma

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-582-4559, 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., St. Louis, Missouri, United States
Additional Information

Lilly Clinical Trial Registry

Starting date: June 2004
Last updated: June 11, 2007

Page last updated: August 23, 2015

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