Status:
COMPLETED
Evaluate the Efficacy and Safety of Pletaal (Cilostazol) in Subjects With Vasospastic Angina
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Variant Angina
Eligibility:
All Genders
20-80 years
Phase:
PHASE2
Brief Summary
The objective of this study is to investigate the efficacy and safety of Pletaal (Cilostazol) in comparison with placebo for 4 weeks in vasospastic angina patients who have an insufficient response to...
Detailed Description
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel group, Therapeutic exploratory Study. The subject who has at least an episode of chest pain weekly despite Amlodipine 5mg once a ...
Eligibility Criteria
Inclusion
- Male or female over the age of 20 and under the age of 80
- Diagnosis of vasospastic angina
- At least one episode of chest pain weekly during the Amlodipine run in period for 2 weeks
Exclusion
- Currently taking or has taken Cilostazol within the last 3 month before the screening.
- Taking oral antiplatelet agents such as Aspirin, Clopidogrel after Amlodipine run-in period.
- Oral anticoagulants such as Warfarin within the last a month before the screening.
- Currently taking any of the following medications or has taken any of the following medications within the last a week before the screening:
- Other Calcium channel blockers than Amlodipine
- Beta-blocker, or Alpha-blocker
- Oral Nitrate, Nicorandil, except sublingual Nitroglycerin as required(PRN)
- Vitamin E preparations
- Estrogens
- History of Myocardial infarction or Myocardial infarction by vasospastic angina at screening
- History of life threatening vasospastic events such as ventricular tachycardia , ventricular fibrillation, or syncope
- History of stroke, intracranial hemorrhage, or Transient Ischemic Attack(TIA)
- Hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) or such tendency (active peptic ulcer, hemorrhagic stroke within past 6 months, a case hemorrhage is suspected by wound for surgery within 3 months, proliferative diabetic retinopathy and uncontrolled hypertension)
- History of clinically significant hypersensitivity to the substances of Cilostazol, Amlodipine, Nitroglycerin or dihydropyridine
- Patients with severe aortic valvular stenosis
- History of shock
- Hypotension of diastolic pressure \< 90 mmHg at screening
- History of clinically significant hypersensitivity to the substances of Nitrates
- Patients with severe anemia of Hemoglobin ≤ 6.5 g/dl at screening
- History of glaucoma
- Electrocardiogram(ECG) abnormality precluding interpretation of ST change at screening
- Congestive heart failure with less than 40% of left ventricular ejection fraction within the last 3 month before the screening or screening period
- Atrial fibrillation or valvular heart disease, more than moderate severity
- Suspected or identified spasm of left main coronary artery, result of coronary angiography or coronary angiography in the ergonovine induced coronary spasm provocation test
- History of Coronary artery bypass graft(CABG) or percutaneous coronary intervention(PCI)
- Tachycardia; Heart rate \> 100 bpm, at Screening
- Uncontrolled hypertension, defined as ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic at Screening
- Creatinine ≥ 1.5 mg/dL at screening
- Aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal (ULN) at screening
- Platelet \< 100,000 mm3 at screening
- QT prolongation defined as baseline QTc \> 450 msec for males or \> 470 msec for females at Screening.
- Women who have the possible of pregnancy, or positive urine or blood pregnancy test at screening
- Women who are not using a reliable method of birth control, who are pregnant, or who are breast-feeding
- Drug compliance of Amlodipine \< 80% during the Amlodipine run in period for 2 weeks
- Otherwise judged by the investigator to be inappropriate for inclusion in the trial.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01444885
Start Date
October 1 2011
End Date
July 1 2012
Last Update
July 16 2012
Active Locations (10)
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1
Keimyung University Dongsan Medical Center
Daegu, South Korea
2
ChungNam Univ. Hospital
Daejeon, South Korea
3
Gangneung Asan Hospital
Gangneung, South Korea
4
Chonnam National University Hospital
Gwangju, South Korea