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Guiding Dose Increases in Patients Incompletely Responsive to Usual Doses of Atomoxetine

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 3

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 trial is to test the value of dose increases in patients with residual ADHD symptoms after treatment with the usual target dose of atomoxetine

Clinical Details

Official title: Guiding Dose Increases In Patients Incompletely Responsive to Usual Doses of Atomoxetine by Determining Plasma Atomoxetine Concentrations: a Randomized, Double-Blind Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Test whether patients treated with atomoxetine 1.2 mg/kg/day who have sub-optimal clinical responses and peak plasma atomoxetine levels no higher than 800 ng/mL will benefit from a dose increase to 2.4 mg/kg/day

Secondary outcome:

Assess the relationship between plasma atomoxetine concentration levels and ADHD symptom response

Compare the efficacy of atomoxetine up to 2.4 mg/kg/day with atomoxetine at 1.2 mg/kg/day in reducing residual ADHD symptoms

Assess the safety and tolerability of atomoxetine at doses up to 2.4 mg/kg/day compared to 1.2 mg/kg/day in patients with peak plasma atomoxetine concentration levels no higher than 800 ng/mL as assessed by AEs elicited during open-ended questioning

Eligibility

Minimum age: 6 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients who are at least 6 years of age and not more than 16 years of age at

Visit 1

- 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 an IQ test)

- Patients must be able to swallow capsules

Exclusion Criteria:

- Patients who weigh less than 25 kg or greater than 70 kg at study entry

- Patients with current or past Bipolar I or II disorder, psychosis, autism, Asperger's

syndrome, or pervasive developmental disorder

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

patients who have taken (or are currently taking) anticonvulsants for seizure control

- Patients with a history of severe allergies to more than 1 class of medications or

multiple adverse drug reactions

- Patients with cardiovascular disease or other conditions that could be aggravated by

an increased heart rate or increased blood pressure

Locations and Contacts

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., Scottsdale, Arizona, United States

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., Vancouver, British Columbia, Canada

Additional Information

Lilly Clinical Trial Registry

Starting date: July 2003
Last updated: October 31, 2007

Page last updated: August 23, 2015

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