Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

NCT ID: NCT02094469

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-01-31

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 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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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

Keywords

Treatment for vasospastic angina

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cilostazol

Cilostazol 50mg and 100mg

Group Type: OTHER

Cilostazol

Intervention Type: DRUG

Oral, Bid, 24 weeks

Interventions

Cilostazol

Oral, Bid, 24 weeks

Intervention Type: DRUG

Other Intervention Names

Pletaal

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects aged 20 to 80 years, and subjects whose age at the time of enrollment was 80 in 021-KOA-1301i clinical trial and is 81 in this clinical trial

2. Subjects who completed 021-KOA-1301i clinical trial

3. Women of childbearing potential with negative pregnancy test at enrollment and who agree to practice a contraceptive measure throughout the clinical trial (e.g., hormonal contraceptives, intrauterine devices, condom + spermicidal agents, diaphragm + spermicidal agents, and partner's infertility)

4. Subjects who signed a written agreement indicating that they were given full explanations of the clinical trial and are willing to participate in the clinical trial

Exclusion Criteria

• Myocardial infarction or myocardial infarction induced by vasospastic angina
• Life-threatening vasospastic episodes (e.g., ventricular tachycardia, ventricular fibrillation, or syncope)
• Stroke, intracranial hemorrhage, or transient ischemic attack (TIA)
• Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)

3. Subjects who are currently using any of the medications contraindicated in 021-KOA-1301i (excluding the investigational product of 021-KOA-1301i) at baseline

4. Subjects who meet the following criteria for baseline laboratory findings

• severe anemia with hemoglobin ≤6.5 g/dl at baseline
• Creatinine level ≥ 1.5 mg/dL at baseline
• AST or ALT >3x ULN at baseline
• Platelet count < 100,000mm3 at baseline

5. Pulse rate exceeding 100 bpm when measured for vital signs at baseline: Tachycardia

6. Hypotension with systolic pressure < 90mmHg at baseline

7. Uncontrolled hypertension defined as systolic pressure ≥ 160 mmHg or diastolic pressure ≥ 100 mmHg at baseline

8. QT prolongation defined as QTcB > 450 msec for men and QTcB > 470 msec for women at baseline

9. Women of childbearing potential with positive pregnancy test at baseline

10. Women who do not agree to practice a contraceptive measure, or are pregnant or lactating

11. Subjects who are not expected to have the potential to benefit from additional administration of Cilostazol, according to the investigator's judgment

12. Subjects otherwise judged by the investigator to be inappropriate for inclusion in the trial

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junghong Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Yangsan Busan University Hospital

Locations

Yangsan Busan University Hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

021-KOA-1302i

Identifier Type: -

Identifier Source: org_study_id