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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00386581
First received: October 6, 2006
Last updated: June 11, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: atomoxetine
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: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 105
Study Start Date: July 2004
Study Completion Date: February 2005
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386581

Locations
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.
Moscow, Russian Federation
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: NCT00386581     History of Changes
Other Study ID Numbers: 9081, B4Z-MW-LYCZ
Study First Received: October 6, 2006
Last Updated: June 11, 2007
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Disease
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
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 September 18, 2014