Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

NCT02094469 | Completed Phase 3

• 1 other identifier: 021-KOA-1302i
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.

Conditions

Vasospastic Angina

Keywords

Treatment for vasospastic angina

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• secondary 1

  24 week

• secondary 2

  4 weeks

• secondary 3

  4 weeks

Study Arms (1)

Cilostazol

OTHER

Cilostazol 50mg and 100mg

Drug: Cilostazol

Interventions

Cilostazol DRUG

Oral, Bid, 24 weeks

Also known as: Pletaal

Cilostazol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subjects who completed 021-KOA-1301i clinical trial
• 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)
• 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

You may not qualify if:

• 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.)
• 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
• 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
• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Yangsan Busan University Hospital

Busan, 626-770, South Korea

Location

MeSH Terms

Conditions

Angina Pectoris, Variant

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Angina, Unstable; Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Junghong Kim, MD

  Yangsan Busan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 21, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

KR (1)