137
Participants
Start Date
December 31, 2011
Primary Completion Date
September 30, 2014
Study Completion Date
October 31, 2014
MCI-186
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
Placebo
Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
MCI-186 in open label phase
All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
Osaka
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
INDUSTRY