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Completed

NCT Number: NCT00641329

CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD

The purpose of this study is to determine if CLONICEL (clonidine HCl sustained release) is a safe and effective add-on to psychostimulant therapy in children and adolescents with attention deficit hyperactivity disorder (ADHD).

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-17 years, inclusive
  • Diagnosis of ADHD
  • Currently on a stable psychostimulant regimen for ADHD
  • Lack of adequate response to stable psychostimulant regimen
  • Ability to swallow tablets

Exclusion criteria

  • Clinically significant illnesses or abnormalities upon evaluation
  • Conduct Disorder
  • Intolerance to clonidine
  • History of seizures or syncope

Treatment and study plan

CLONICEL (Clonidine HCl sustained release)

Drug

Flexible Dose (0.1 - 0.4 mg)

Placebo

Drug

Matching placebo tablets

Primary outcomes

  1. ADHDRS-IV Total Score

    Time frame: Week 5

  2. Treatment Emergent Adverse Events, Laboratory Tests, Vital Signs, and ECGs

    Time frame: Throughout Treatment and Follow-up Period

Sponsors and collaborators

Lead sponsor

Addrenex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Phase III Evaluation of the Safety and Efficacy of CLONICEL (Clonidine HCl Sustained Release) as Add-on to Psychostimulant Medication vs. Psychostimulant Medication Alone in Children and Adolescents With ADHD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2008
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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