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

Phase 3

Completed

• Conditions: Vasospastic Angina
• Interventions: Drug: placebo; Drug: Cilostazol

• Registration Number: NCT02087007
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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 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 Description

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-17
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-14
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	placebo	placebo
group 1	Cilostazol	Cilostazol 50mg, Cilostzaol 100mg

Primary Outcome Measures

Name	Time	Method
Chest Pain Frequency	Baseline and Week 4	Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yangsan Busan University Hospital; 🇰🇷 Busan, Korea, Republic of