NCT02094469

Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.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

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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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.

Conditions

• Vasospastic Angina

Interventions

Type	Name	Description
DRUG	Cilostazol	Oral, Bid, 24 weeks

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-03-21
• Last updated: 2016-01-29

Locations

1 site across 1 country: South Korea