drugset / Trial / NCT01500694

Access to Extended Release Guanfacine HCl for Subjects Who Participated in Studies SPD503-315 or SPD503-316 in Europe

NCT01500694

Phase 3 Completed 215 enrolled Shire
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2012-03-20
Primary completion
2015-09-15
Completion
2015-09-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Guanfacine Small molecule 1 mg Oral
Subject Guanfacine Small molecule 2 mg Oral
Subject Guanfacine Small molecule 3 mg Oral
Subject Guanfacine Small molecule 4 mg Oral
Subject Guanfacine Small molecule 5 mg Oral
Subject Guanfacine Small molecule 6 mg Oral
Subject Guanfacine Small molecule 7 mg Oral