Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

June 11, 2007 updated by: Eli Lilly and Company

Phase III Multicenter, Randomized, Double-Blind Placebo-Controlled Outpatient Study of Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Russian Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Moscow, Russian Federation
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Subjects must have ADHD that meets the DSM-IV criteria
  • Aged 6 to 16 years.
  • Subjects must not have taken any medication used to treat ADHD.
  • Laboratory results must show no significant abnormalities
  • Baseline ECG results must not show an abnormality
  • Subjects must be able to swallow capsules.
  • Subjects must be of normal intelligence.

Exclusion Criteria

  • Weigh less than 20 kg or more than 60 kg at study entry.
  • Subjects who, after an adequate trial with methylphenidate or amphetamine experience some benefit in ADHD signs and symptoms are excluded from participating.
  • Have a history of Bipolar I or II disorder, psychosis, or PDD.
  • Meet DSM-IV criteria for an anxiety disorder.
  • Have a history of any seizure disorder.
  • Patients at serious suicidal risk.
  • Patients with narrow angle glaucoma
  • Subjects who have a history of severe allergies .
  • Have a history of alcohol or drug abuse within the past 3 months
  • Screen positive for drugs of abuse not prescribed by a physician.
  • Have cardiovascular disease and an increased heart rate and blood pressure.
  • Have a medical condition that would increase sympathetic nervous system activity markedly or who are taking a medication on a daily basis.
  • Have severe gastrointestinal narrowing
  • Are during the study time likely to need psychotropic medications.
  • Are likely to begin a structured psychotherapy aimed at ADHD symptoms.
  • Have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks
  • Female subjects who are pregnant or who are breast-feeding.
  • Are investigative site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.
  • Are, in the opinion of the investigator, unsuitable in any other way to participate in this study.
  • Are employed by Lilly.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

Secondary Outcome Measures

Outcome Measure
To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners
To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

June 12, 2007

Last Update Submitted That Met QC Criteria

June 11, 2007

Last Verified

June 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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