62
Participants
Start Date
April 9, 2007
Primary Completion Date
March 1, 2009
Study Completion Date
March 10, 2009
Ropinirole prolonged release/extended release(PR/XR)
Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).
GSK Investigational Site, Aichi
GSK Investigational Site, Aichi
GSK Investigational Site, Chiba
GSK Investigational Site, Ehime
GSK Investigational Site, Hokkaido
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kyoto
GSK Investigational Site, Numakunai
GSK Investigational Site, Osaka
GSK Investigational Site, Saitama
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
Lead Sponsor
GlaxoSmithKline
INDUSTRY