Vasospastic Angina Clinical Trial
Official title:
A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)
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 Withdrawn subjects due to efficacy after 4 weeks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 Withdrawn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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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