NCT00641329

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

April 9, 2010

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

March 19, 2008

Last Update Submit

April 8, 2010

Conditions

ADHD

Keywords

ADHDADDAttention Deficit Hyperactivity DisorderAttention DeficitClonidineCLONICELAddrenex

Outcome Measures

Primary Outcomes (2)

  • ADHDRS-IV Total Score

    Week 5

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

    Throughout Treatment and Follow-up Period

Study Arms (2)

1

EXPERIMENTAL
Drug: CLONICEL (clonidine HCl sustained release)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CLONICEL (clonidine HCl sustained release)DRUG

Flexible Dose (0.1 - 0.4 mg)

1
PlaceboDRUG

Matching placebo tablets

2

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

El Centro, California, 92243, United States

Location

Unknown Facility

Irvine, California, 92612, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Bradenton, Florida, 34208, United States

Location

Unknown Facility

Lauderhill, Florida, 33319, United States

Location

Unknown Facility

Miami, Florida, 33161, United States

Location

Unknown Facility

Bardstown, Kentucky, 40004, United States

Location

Unknown Facility

Baltimore, Maryland, 21208, United States

Location

Unknown Facility

St Louis, Missouri, 63005, United States

Location

Unknown Facility

Clementon, New Jersey, 08021, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73116, United States

Location

Unknown Facility

Houston, Texas, 77007, United States

Location

Unknown Facility

Houston, Texas, 77074, United States

Location

Unknown Facility

Lake Jackson, Texas, 77566, United States

Location

Unknown Facility

Wharton, Texas, 77488, United States

Location

Unknown Facility

Clinton, Utah, 84015, United States

Location

Unknown Facility

Kirkland, Washington, 98033, United States

Location

Unknown Facility

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Moise Khayrallah, PhD

    Addrenex Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 24, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

April 9, 2010

Record last verified: 2009-03

Locations

US(23)