123
Participants
Start Date
June 30, 2007
Primary Completion Date
December 31, 2009
Study Completion Date
December 31, 2009
ROP
Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.
ROP+L-Dopa
Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
GSK Investigational Site, Chiba
GSK Investigational Site, Fukuoka
GSK Investigational Site, Fukuoka
GSK Investigational Site, Fukuoka
GSK Investigational Site, Hyōgo
GSK Investigational Site, Ibaraki
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kyoto
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyagi
GSK Investigational Site, Numakunai
GSK Investigational Site, Osaka
GSK Investigational Site, Osaka
GSK Investigational Site, Osaka
GSK Investigational Site, Osaka
GSK Investigational Site, Osaka
GSK Investigational Site, Saga
GSK Investigational Site, Saitama
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
Lead Sponsor
GlaxoSmithKline
INDUSTRY