Trials / Completed
CompletedNCT00641329
CLONICEL (Clonidine Sustained Release) as Add-on to Stimulant Medication in 6 to 17 Yr-olds With ADHD
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- Addrenex Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CLONICEL (clonidine HCl sustained release) | Flexible Dose (0.1 - 0.4 mg) |
| DRUG | Placebo | Matching placebo tablets |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2008-03-24
- Last updated
- 2010-04-09
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00641329. Inclusion in this directory is not an endorsement.