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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks
100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks
Yangsan Busan University Hospital
Busan, South Korea
Chest Pain Frequency
Change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
Time frame: Baseline and Week 4
Percent change of the chest pain frequency
Percent change of the chest pain frequency on the final a week after IP dosing from a week before IP dosing
Time frame: Baseline and Week 4
Proportion of subjects without chest pain
Proportion of subjects without chest pain on the final a week after IP dosing
Time frame: 4 weeks
total chest pain intensity
Change of the total pain intensity on the final a week after IP dosing from a week before IP dosing
Time frame: Baseline and Week 4
average pain intensity(the total pain intensity/the number of pain)
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
Time frame: Baseline and Week 4
total nitroglycerin sublingual consumption
Change of the total nitroglycerin sublingual consumption of the final a week after IP dosing from a week before IP dosing
Time frame: Baseline and Week 4
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