Trials / Completed
CompletedNCT01500694
Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe
A Phase 3, Open-label, Multicentre Study to Provide Access to Guanfacine Hydrochloride Extended-release for European Subjects With Attention-deficit/Hyperactivity Disorder (ADHD) Who Participated in Study SPD503-315 or SPD503-316
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 215 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
For subjects in Europe that have already participated in either Study SPD503-315 or SPD503-316. This is an extension study that will allow participants access to Extended-release Guanfacine Hydrochloride (HCl) for up to 2 years. This study will help the sponsor evaluate long-term safety and tolerability of Extended-release Guanfacine HCl (SPD503).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Extended-release Guanfacine HCl (Intuniv, SPD503) | Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age |
Timeline
- Start date
- 2012-03-20
- Primary completion
- 2015-09-15
- Completion
- 2015-09-15
- First posted
- 2011-12-28
- Last updated
- 2021-06-16
- Results posted
- 2017-05-18
Locations
60 sites across 13 countries: Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01500694. Inclusion in this directory is not an endorsement.