A Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Cilostazol in Subjects With Vasospastic Angina
Information source: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vasospastic Angina
Intervention: Cilostazol (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Korea Otsuka Pharmaceutical Co.,Ltd. Overall contact: Junghong Kim, M.D, Phone: 010-8231-7171, Ext: 055-360-1453, Email: junehongk@gmail.com
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 KFDA.
Each subject will participate around 7 weeks, which include the 2 weeks Amlodipine run-in
period, 4 weeks double blind period and 1 week safety follow up period
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Pletaal(Cilostazol) in Subjects With Vasospastic Angina
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Chest Pain Frequency
Secondary outcome: Percent change of the chest pain frequencyProportion of subjects without chest pain total chest pain intensity average pain intensity(the total pain intensity/the number of pain) total nitroglycerin sublingual consumption
Detailed description:
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic
confirmatory Study.
The subject who has at least one episode of chest pain weekly and at least two episodes of
chest pain during last week despite Amlodipine 5mg qd taking during 2 weeks will have
treatment of Pletaal(Cilostazol) or Placebo for 4 weeks. Pletaal(Cilostazol) is taken 100mg
oral tablets bid during 2 weeks after dosing of Pletaal(Cilostazol) 50mg oral tablets bid
during 2 weeks. Placebo of Pletaal(Cilostazol) is used as the control medication.
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study :
1. Male or female 20 or over the age of 20 and under the age of 80.
2. Patients showing angina attack even while resting during the screening, diagnosed
with vasospastic angina within the previous 3 months by meeting at least one of the 3
definitions, and accompanying insignificant (stenosis rate <50%) coronary artery
disease documented by coronary angiography within the last 3 months [temporary
antispastic agents (monotherapies or a combination of Verapamil and Nitroglycerin,
anticoagulants) for coronary angiography are allowed]
- Chest pain accompanied by at least 2 temporary, closely located ST elevations or
depressions of 0. 1mV or greater in the absence of ergonovine provoked coronary
angiography.
- Positive Intracoronary (IC) or Intravenous (IV) Ergonovine provocation test;
ischemic ECG change accompanied by chest pain and spasm reducing the coronary
diameter by 90% or more (at least 2 temporary, closely located ST elevations or
depressions of 0. 1mV or greater on 12-lead ECG)
3. Patients who reported at least 1 episode of chest pain in a week during amlodipine
run-in period and at least 2 episodes in the final week.
4. Women who had been menopausal or sterile for at least 1 year, or women of
childbearing potential 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)
5. 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.
Subjects presenting with any of the following will not be included in the study:
1. Subjects who used Cilostazol within 3 months before the screening visit
2. Subjects who used antiplatelet drugs, including Aspirin, Clopidogrel, Ticlopidine and
Sarpogrelate, or PDE3 inhibitors of the same class as Cilostazol, such as Amrinone,
Milrinone and Enoximone, after the initiation of the amlodipine run-in period
3. Subjects who used oral anticoagulants, such as warfarin, within 1 months prior to the
screening visit
4. Subjects who used any of the following drugs within 1 week prior to the screening
visit
- CCBs apart from amlodipine
- Beta-blockers or alpha-blockers
- Oral nitrate, excluding nitroglycerin sublingual tablet, Nicorandil
- Vitamin E preparations
- Estrogens
5. History of myocardial infarction or with myocardial infarction mediated by
vasospastic angina at the time of screening
6. History of a life-threatening vasospastic event (e. g., ventricular tachycardia,
atrial fibrillation or syncope)
7. History of stroke, intracranial hemorrhage or transient ischemic attack (TIA)
8. Hemorrhage (hemophilia, capillary fragility, upper gastrointestinal bleeding, urinary
tract bleeding, hemoptysis, vitreous hemorrhage, etc.) or such predisposition (active
peptic ulcer, hemorrhage suspected at Cilostazol administration for surgical wound
within the last 3 months, proliferative diabetic retinopathy)
9. History of hypersensitivity to the ingredients of Cilostazol, amlodipine,
dihydropyridines such as nitroglycerine, and nitrates
10. Severe aortic stenosis
11. History of shock
12. Hypotension with systolic pressure of below 90mmHg at screening
13. Severe anemia with hemoglobin 6. 5g/dl or below at screening
14. History of glaucoma
15. ST change abnormality not interpretable on ECG at screening
16. Congestive heart failure with left ventricular ejection fraction <40% on
echocardiography at screening or within the last 3 months
17. Atrial fibrillation or beyond moderate valvular heart disease
18. Left main coronary spasm suspected or confirmed by coronary angiography or ergonovine
provoked coronary angiography
19. History of coronary artery bypass graft (CABG) or percutaneous coronary intervention
(PCI)
20. Heart rate >100 bpm at screening via vital sign: tachycardia
21. Uncontrolled hypertension with systolic pressure ≥ 160 mmHg or diastolic pressure ≥
100 mmHg at screening
22. Creatinine level ≥ 1. 5 mg/dL at screening
23. AST or ALT > x3 ULN(Upper Limit of Normal) at screening
24. Platelet count < 100,000mm3 at screening
25. QT prolongation of QTcB > 450 msec in male and QTcB>470 msec in female subjects at
screening
26. Women of childbearing potential with positive pregnancy test at screening
27. Women who did not agree to practice a contraceptive measure, pregnant or lactating
women
28. Drug compliance of less than 80% during 2-week amlodipine run-in period
29. Subjects otherwise judged by the investigator to be inappropriate for inclusion in
the trial
30. Subjects who used another investigational products within 2 months prior to the
randomization
Locations and Contacts
Junghong Kim, M.D, Phone: 010-8231-7171, Ext: 055-360-1453, Email: junehongk@gmail.com
Yangsan Busan University Hospital, Busan 626-770, Korea, Republic of; Recruiting Junghong Kim, M.D, Phone: 055-360-1453, Email: junehongk@gmail.com JunHong Kim, MD, Principal Investigator
Additional Information
Starting date: November 2013
Last updated: October 17, 2014
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