This study will be conducted in accordance with the local regulation of New Drug Application. Overall duration of this trial will be 3 years after approval of MFDS. Each subject will participate around 26 weeks, which include the 24 weeks treatment period and 2 weeks safety follow up period. Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.
A Multicenter, One group, Open-label Study. Cilostazol will be treated for additional 24 weeks to the subject who had completed 021-KOA-1301i study. PletaalÒ(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÒ(Cilostazol) 50mg oral tablets bid during 1 week. The dose can be adjusted by investigator's discretion during the study and the detailed method is described in the Protocol. Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.). Subjects who participated in this trial will have 2 weeks follow-up after study completion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Oral, Bid, 24 weeks
Yangsan Busan University Hospital
Busan, South Korea
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Time frame: 24 weeks
secondary 1
Change/rate of change in the frequency of chest pain in the final 1week/2 weeks after the 24-week treatment period compared to those in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i
Time frame: 24 week
secondary 2
Mean change in the intensity of chest pain in the final 1 week/2 weeks after the 24-week treatment period compared to that in the final 1 week/2weeks of Amlodipine run-in period in 021-KOA-1301i
Time frame: 4 weeks
secondary 3
4-week cumulative rate of subjects withdrawn due to lack of efficacy
Time frame: 4 weeks
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