NCT02294942已完成3 期
A Double-blind, Randomized, Placebo-controlled, Parallel Study to Evaluate the Effects of add-on RANCAD on Exercise Tolerance and Angina Frequency in Patients With Stable Angina Pectoris.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- ETT performing at last treatment visit (Week 12).
研究概览
简要总结
A double-blind, randomized, placebo-controlled, parallel study to evaluate the effects of add-on RANCAD on exercise tolerance and angina frequency in patients with stable angina pectoris.
详细描述
Primary objective is to to determine the effects of add-on RANCAD on exercise treadmill test (ETT) duration at trough plasma level of RANCAD level after 12-weeks therapy.
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
- Triple (Participant, Care Provider, 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 patients aged ≥ 20 years old
- •A minimum 3-month history of stable angina
- •Patients with diagnosis of coronary artery disease (CAD)
- •Patients present with the symptoms of stable angina after withdrawn from other antianginal drugs and given the required background therapy for at least 7 days will be qualified for entering this study and performing 1st ETT qualifying test
- •Patients developed exercise-induced ECG ischemiai during two qualifying exercise treadmill testsii. The difference between twoiii tests should be ≤ 20% of the longer test or ≤ 1 minute i. Exercise-induced ECG ischemia is defined as the new development of horizontal or down-sloping ST-segment depression of ≥1mm at 60-80ms after the J point; if patients with baseline ST depression at rest (<1mm), qualifying ST segment depression is defined as additional ST depression of at least 1 mm below the resting value ii. Exercise treadmill test (ETT) will be performed by Modified Bruce Protocol. iii. Two qualifying tests will be conducted 1 week apart, a 3rd ETT test will be performed ≤ 3 days when differences between previous two qualifying ETTs >20% of the longer test or >1 minute
- •Willing and able to provide a written informed consent
排除标准
- •Factors that might compromise ECG or ETT interpretation
- •Patients with resting ST-segment depression ≥ 1mm in any lead
- •Left bundle-branch block
- •Patients implanted with pacemaker
- •Patients under Digitalis therapy
- •Patients with family history of (or congenital) long QT syndrome
- •Patients with congenital heart disease
- •Patients with uncorrected valvular heart disease
- •Patients with unstable angina, or MI, or coronary revascularization procedure ≤ 2 months prior enter this study
- •Female who is pregnant/lactating or planning to be pregnant, or female of childbearing potential* who is not using medically recognized method of contraception
- •*Other than those who have been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
- •Patients are under any one of the following conditions:
- •New York Heart Association (NYHA) Class III or Class IV congestive heart failure (CHF)
- •QTc > 450 msec at screening
- •Active myocarditis, pericarditis, hypertrophic cardiomyopathy
- •Uncontrolled hypertension (defined as SBP > 180 mmHg) Voltage criteria for left ventricular hypertrophy in the absence of repolarization abnormalities will not be exclusion criteria
- •Use of any investigational product ≤ 4 weeks prior to screening
- •Patients with severe hepatic disease (e.g., liver cirrhosis)
- •Patients with impaired renal function (defined as serum Cr >1.5 mg/dl)
- •Patients with any condition or disease which is considered not suitable for this study by investigator
研究组 & 干预措施
RANCAD 500mg
Experimental
RANCAD 1 tab (500 mg) + Placebo 1 tab, twice daily.
干预措施: RANCAD (Drug)
RANCAD 1000mg
Experimental
RANCAD 2 tabs (500 mg), twice daily
干预措施: RANCAD (Drug)
Placebo
Active Comparator
2 tabs, twice daily
干预措施: RANCAD (Drug)
结局指标
主要结局
ETT performing at last treatment visit (Week 12).
时间窗: Week 12 (not including screening & follow-up period)
To compare the change from baseline of ETT performing duration between add-on RANCAD and placebo at trough (12 hours after dosing) at Week 12.
次要结局
未报告次要终点
研究者
研究点 (6)
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