Clinical Trial: Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.


Detailed Summary: 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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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.
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: 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 ]

Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period


Original Primary Outcome: Proportion of subjects without chest pain on the final a week/final 2 weeks after 24 weeks treatment. [ Time Frame: 24 weeks ]

Proportion of subjects without chest pain on the final a week/final 2 weeks after 24 weeks treatment.


Current Secondary Outcome:

  • secondary 1 [ Time Frame: 24 week ]
    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
  • secondary 2 [ Time Frame: 4 weeks ]
    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
  • secondary 3 [ Time Frame: 4 weeks ]
    4-week cumulative rate of subjects withdrawn due to lack of efficacy


Original Secondary Outcome:

  • secondary 1 [ Time Frame: 24 week ]
    Change/Percent change of the chest pain frequency on the final a week/final 2 weeks after 24 weeks treatment compared to final a week/final 2 weeks on Amlodipine run-in period of 021-KOA-1301i.
  • secondary 2 [ Time Frame: 4 weeks ]
    Change of the chest pain intensity on the final a week/final 2 weeks after 24 weeks treatment compared to final a week/final 2 weeks on Amlodipine run-in period of 021-KOA-1301i.
  • secondary 3 [ Time Frame: 4 weeks ]
    Cumulative proportion of withdrawn subjects due to lack of efficacy at every 4 weeks.


Information By: Korea Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: March 20, 2014
Date Started: December 2013
Date Completion:
Last Updated: January 27, 2016
Last Verified: January 2016