Safety and Efficacy Study of Cilostazol to Treat Vasospastic Angina

Vasospastic Angina Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094469
• Other study ID #: 021-KOA-1302i
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2014
• Last updated: January 27, 2016
• Start date: December 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

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 Withdrawn subjects due to efficacy after 4 weeks treatment will participate in 6 weeks in total including 2 weeks safety follow up. Withdrawn subjects with other reason also have 2 weeks follow up period.

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 Subject who has 2 or more chest pain at 4th week will be withdrawn from the study (But, subjects who show 50% or more of chest pain decrease compared to 1st week would not be withdrawn.).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Vasospastic Angina

Intervention

Drug:
• Cilostazol
Oral, Bid, 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Yangsan Busan University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	4 weeks	No
Secondary	secondary 3	4-week cumulative rate of subjects withdrawn due to lack of efficacy	4 weeks	No