A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of PletaalÒ(Cilostazol) in Subjects With Vasospastic Angina (STELLA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Percent change of the chest pain frequency
研究概览
简要总结
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 Amlodipine (Calcium channel blocker).
详细描述
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 day (qd) taking during 2 weeks will have treatment of Pletaal (Cilostazol) or Placebo for 4 weeks. Pletaal (Cilostazol) is taken 100mg oral tablets two times a day (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Cilostazol
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 Amlodipine (Calcium channel blocker).
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change of the chest pain frequency
时间窗: A week before IP dosing and the final a week after IP dosing (average 6weeks)
Collect the chest pain frequency data related with vasospastic angina episodes by subject diaries. Descriptive statistics (N, mean, standard deviation, minimum, median and maximum) will be presented by treatment group. ANCOVA will be performed between the treatment groups using the baseline (a week before IP dosing) as covariate.
次要结局
- The chest pain frequency, the pain intensity, nitroglycerin consumption of the final a week after IP dosing from a week before IP dosing(A week before IP dosing and the final a week after IP dosing (average 6weeks))