A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy 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
- 79
- 试验地点
- 3
- 主要终点
- Change in Total Exercise Time
研究概览
简要总结
The objectives of this study are to evaluate the efficacy, pharmacological activities and safety of STA-2 in the treatment of chronic stable angina.
详细描述
The primary objective of this study was to evaluate the efficacy of STA-2 in the management of chronic stable angina. The secondary objectives of this study were to evaluate the safety and pharmacological activities of STA-2 in the management of chronic stable angina. This was a multi-center, double-blind, randomized, parallel-group, placebo-controlled study of STA-2 in the management of chronic stable angina. The study period for each patient was approximately 7 weeks, during which the patient undergone one-week screening and washout period, followed by 6 weeks of treatment. Each patient was required to make a total of 5 visits. Primary Efficacy Endpoint: Change in total exercise time.
After washout, patients who met the inclusion and exclusion criteria were randomly assigned either to the treatment or control group. The respective regimens were:
Treatment group:
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules ter in die (t.i.d.=three times daily) for 6 weeks, to be administered in a non-fasting state.
Control group:
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
STA-2
STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.
Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
干预措施: STA-2 (Drug)
Placebo
Placebo capsule, containing non-active ingredients.
Two capsules t.i.d. (three times daily) for 6 weeks, to be administered in a non-fasting state.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Exercise Time
时间窗: baseline (visit 2) and week 6 (visit 5)
Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.
次要结局
- Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).(baseline (visit 2) through week 6 (visit 5))
- Change in Consumption of Short-acting Nitrates(from baseline (visit 2) through week 6 (visit 5))
- Change in Rate-pressure Product(baseline (visit 2) to week 6 (visit 5))
- Change in Pharmacological Parameters(baseline (visit 2) to week 6 (visit 5))
- Consumption of Short-acting Nitrates(The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.)