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Study Evaluating the Safety and Efficacy of CLONICEL® to Treat Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00556959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2010-03-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether CLONICEL® (clonidine HCl sustained release) is a safe and effective treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD).

Conditions

  • Attention Deficit Disorder With Hyperactivity

Interventions

DRUG

high dose clonidine HCl sustained release

high dose clonidine HCl sustained release tablets for 8 weeks

DRUG

low dose clonidine HCl sustained release

low dose clonidine HCl sustained release tablets for 8 weeks

DRUG

placebo

placebo tablets for 8 weeks

Sponsors & Collaborators

  • Addrenex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Moise A Khayrallah, PhD · Addrenex Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556959 on ClinicalTrials.gov