Trials / Completed
CompletedNCT01470469
SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP)
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Tolerability of SPD503 in Subjects Aged 6-17 Years With Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), or Social Phobia (SoP).
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and tolerability of SPD503 in subjects aged 6-17 years with GAD, SAD, or SoP based on treatment emergent adverse events (TEAEs), vital signs and ECGs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD503 (extended-release Guanfacine hydrochloride) | Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance). |
| DRUG | Placebo | Once-daily oral dosing in the evening for 12 weeks. |
Timeline
- Start date
- 2012-01-04
- Primary completion
- 2013-07-15
- Completion
- 2013-07-15
- First posted
- 2011-11-11
- Last updated
- 2021-06-10
- Results posted
- 2014-05-23
Locations
33 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01470469. Inclusion in this directory is not an endorsement.