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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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.
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. PletaalÃ’(Cilostazol) is taken 100mg oral tablets bid during 2 3weeks after dosing of PletaalÃ’(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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cilostazol | Other | Cilostazol 50mg and 100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | Oral, Bid, 24 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period | Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| secondary 1 | 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 | 24 week |
| secondary 2 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i
Subjects who reported any of the following events, which fall under the exclusion criteria for KOA-1301i, between the initiation of 021-KOA-1301i participation and enrollment visit for 021-KOA-1302i
Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline
Subjects who meet the following criteria for baseline laboratory findings
Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia
Hypotension with systolic pressure < 90mmHg at baseline
Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline
QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline
Women of childbearing potential with positive pregnancy test at baseline
Women who do not agree to practice a contraceptive measure, or are pregnant or lactating
Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment
Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial
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| Name | Affiliation | Role |
|---|---|---|
| Junghong Kim, MD | Yangsan Busan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangsan Busan University Hospital | Busan | 626-770 | South Korea |
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| ID | Term |
|---|---|
| D000788 | Angina Pectoris, Variant |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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
| 4 weeks |
| secondary 3 | 4-week cumulative rate of subjects withdrawn due to lack of efficacy | 4 weeks |
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |