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

NCT00641329 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2010-04-09

No results posted yet for this study

Summary

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).

Conditions

  • ADHD

Interventions

DRUG

CLONICEL (clonidine HCl sustained release)

Flexible Dose (0.1 - 0.4 mg)

DRUG

Placebo

Matching placebo tablets

Sponsors & Collaborators

  • Addrenex Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Moise Khayrallah, PhD · Addrenex Pharmaceuticals

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
2008-02-29
Primary Completion
2009-02-28
Completion
2009-02-28

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 NCT00641329 on ClinicalTrials.gov