Trials / Completed
CompletedNCT00367835
SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms
A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 217 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD503 (Guanfacine hydrochloride) | Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day). |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2006-12-04
- Primary completion
- 2008-01-04
- Completion
- 2008-01-04
- First posted
- 2006-08-23
- Last updated
- 2021-06-14
- Results posted
- 2009-11-26
Locations
34 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00367835. Inclusion in this directory is not an endorsement.