A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Dose-Response and Safety of STA-2 in Patients With Chronic Stable Angina
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 5
- 主要终点
- Change in Total Exercise Time (Seconds)
研究概览
简要总结
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
详细描述
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.
Treatment Group A:
150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
Treatment Group B:
300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≧ 20 years;
- •Subjects weight > 50 kg
- •subjects who had more than 50% coronary stenosis documented by catheterization or ever received coronary intervention;
- •The two ETT results at screening (Visit 1) and baseline (Visit 2) show greater than or equal to 1 mm ST-segment depression within exercise duration;
- •The difference in exercise duration between screening (Visit 1) and baseline (Visit 2) do not exceed 20% of the longer test;
- •Able to provide written informed consent.
排除标准
- •Subjects with pacemaker rhythm, unstable angina or myocardial infarction within the preceding 3 months;
- •Subjects with heart failure (New York Heart Association class III or IV), uncorrected valvular or congenital heart disease, subjects who need digoxin or digitalis;
- •Subjects with any resting EKG abnormalities preventing the interpretation of ischemia as judged by the investigator;
- •Subjects with COPD requiring bronchodilators;
- •Subjects with impaired hepatic function (defined as AST or ALT > 2X the upper limit of normal values), or impaired renal function (defined as serum creatinine > 1.5 mg/dL), or diagnosis of any chronic renal/hepatic disease;
- •Subjects with documented evidence of gastroduodenal ulcer disease, gastrointestinal bleeding or other gastrointestinal disease within the preceding 3 months as judged by investigator;
- •Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with safety assessments during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;
- •Subject with any conditions that could interfere the performance of exercise tolerance test as judged by investigator (e.g., knee/ankle arthropathy, Parkinsonism, stoke);
- •Female subjects of childbearing potential who:
- •are lactating;
- •have positive pregnancy test (urine) at V1;
- •Subject has received any investigational agent within 28 days prior to the first dose of investigational product;
- •Subjects who have had administered STA-2 in prior clinical trial.
研究组 & 干预措施
Placebo group
placebo capsule 2# t.i.d./day
干预措施: green tea polyphenols (STA-2) (Drug)
Treatment Group A
150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
干预措施: green tea polyphenols (STA-2) (Drug)
Treatment Group B
300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
干预措施: green tea polyphenols (STA-2) (Drug)
Treatment Group C
450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
干预措施: green tea polyphenols (STA-2) (Drug)
结局指标
主要结局
Change in Total Exercise Time (Seconds)
时间窗: 6 weeks after the first exercise tolerance testing is conducted
the time difference of total exercise time from V2 to V5 compare to placebo
次要结局
- Changes in Time to 1mm ST-segment Depression During ETT From Baseline to Final Visit(6 weeks)
- Change in Time to Onset of Angina From Baseline to the Final Visit(6 weeks)
- Changes in Time to Maximum ST-segment Depression During ETT From Baseline to the Final Visit(6 weeks)
- Changes in Angina Frequency in Subject's Diary From Baseline to All Visits(6 weeks)
- Change in Consumption of Short-acting Nitrates From Baseline to All Visits(6 weeks)
- Change in Pharmacological Parameters (Oxidized-LDL), Isoprostane and High-sensitivity Hs-CRP From Baseline to All Visits(6 weeks)
- Change in Lipid Profiles (HDL-C, LDL-C, Total Cholesterol, Triglyceride) From Baseline to All Visits(6 weeks)
- Dose-response Relationship of Three Different Dose Levels of STA-2 Versus Placebo Control in Change in Total Exercise Time.(6 weeks)