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

Addrenex Pharmaceuticals, Inc.198 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

198

Conditions

ADHD

Interventions

CLONICEL (clonidine HCl sustained release)DRUG

Flexible Dose (0.1 - 0.4 mg)

PlaceboDRUG

Matching placebo tablets

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (23)

Unnamed facility

Little Rock, Arkansas, United States

Unnamed facility

El Centro, California, United States

Outcomes

Primary Outcomes

ADHDRS-IV Total Score

Time frame: Week 5

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

Time frame: Throughout Treatment and Follow-up Period

Data from ClinicalTrials.gov

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