Clinical Trial: A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina

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

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With 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 KFDA.

Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in period, 4 weeks double blind period and 1 week safety follow up period


Detailed Summary:

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic confirmatory Study.

The subject who has at least one episode of chest pain weekly and at least two episodes of chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.


Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Current Primary Outcome: Chest Pain Frequency [ Time Frame: Baseline and Week 4 ]

Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percent change of the chest pain frequency [ Time Frame: Baseline and Week 4 ]
    Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
  • Proportion of subjects without chest pain [ Time Frame: 4 weeks ]
    Proportion of subjects without chest pain on the final a week after IP dosing
  • total chest pain intensity [ Time Frame: Baseline and Week 4 ]
    Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing
  • average pain intensity(the total pain intensity/the number of pain) [ Time Frame: Baseline and Week 4 ]
    Change of the average pain intensity(the total pain intensity/the number of pain) on the final a week after IP dosing from a week before IP dosing
  • total nitroglycerin sublingual consumption [ Time Frame: Baseline and Week 4 ]
    Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing


Original Secondary Outcome: Same as current

Information By: Korea Otsuka Pharmaceutical Co., Ltd.

Dates:
Date Received: February 17, 2014
Date Started: November 2013
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017