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Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina (STELLA_Ext)

Primary Purpose

Vasospastic Angina

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasospastic Angina focused on measuring Treatment for vasospastic angina

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  1. Subjects who fell under one of the exclusion criteria at the time of enrollment for 021-KOA-1301i

  2. 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

    • 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

Sites / Locations

  • Yangsan Busan University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cilostazol

Arm Description

Cilostazol 50mg and 100mg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
secondary 2
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
secondary 3
4-week cumulative rate of subjects withdrawn due to lack of efficacy

Full Information

First Posted
March 20, 2014
Last Updated
January 27, 2016
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02094469
Brief Title
Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina
Acronym
STELLA_Ext
Official Title
A Multicenter, One Group, Open-label Study to Evaluate the Safety and Efficacy of Pletaal(Cilostazol) as BID for up to 24 Weeks Exposure in Subjects With Vasospastic Angina (STELLA Extension)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasospastic Angina
Keywords
Treatment for vasospastic angina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol
Arm Type
Other
Arm Description
Cilostazol 50mg and 100mg
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletaal
Intervention Description
Oral, Bid, 24 weeks
Primary Outcome Measure Information:
Title
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Description
Proportion of the subjects whose chest pain was not present in the final 1 week/2 weeks after the 24-week treatment period
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
secondary 1
Description
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
Time Frame
24 week
Title
secondary 2
Description
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
Time Frame
4 weeks
Title
secondary 3
Description
4-week cumulative rate of subjects withdrawn due to lack of efficacy
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junghong Kim, MD
Organizational Affiliation
Yangsan Busan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yangsan Busan University Hospital
City
Busan
ZIP/Postal Code
626-770
Country
Korea, Republic of

12. IPD Sharing Statement

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Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

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