NCT02232607已完成2 期
A Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel Group, Dose Ranging Study to Investigate the Efficacy and Safety of Lacidipine in Chronic Stable Angina.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 283
- 主要终点
- Change in total treadmill exercise duration
研究概览
简要总结
The aim of this study was to explore whether lacidipine at doses of 2 mg, 4 mg and 6 mg decreased the symptoms of angina, compared to placebo in patients with chronic stable angina
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years
- •History of stable, exertional angina pectoris (Canadian Cardiovascular Society functional class II to III) for at least 3 months duration prior to enrolment in the study
- •Patients not currently receiving treatment with antianginal medication (other than short-acting nitrates)
- •Between visits 2 and 3 two treadmill exercise tests, demonstrating ≥ 0.1 mV of horizontal or down sloping ST-segment depression, must be carried out. The difference in symptom-limited exercise duration between these two tests must not exceed 20%
- •Total treadmill exercise duration > 3 minutes (i.e. stage 2 or above on a standard Bruce protocol)
- •Coronary artery disease, preferably (not mandatory) documented by a history of proven myocardial infarction and/or coronary angiography indicating ≥ 50% reduction in luminal diameter of one or more coronary arteries or their primary branches
排除标准
- •Myocardial infarction within 3 months prior to enrolment in the study
- •Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass surgery within 6 months
- •Other types of angina (variant, unstable)
- •Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
- •Resting heart rate < 50 bpm or > 100 bpm
- •Significant valvular heart disease
- •Heart failure New York Heart Association Class III or IV
- •Chronic obstructive pulmonary disease and/or asthma with clinical symptoms requiring regular medication
- •Significant arrhythmia (since this may interfere with the interpretation of the electrocardiogram) including Wolff Parkinson-White syndrome, atrial fibrillation, atrial flutter, sick sinus syndrome, significant Atrio-Ventricular heart block, intraventricular conduction defect (QRS > 0.12 seconds) ventricular pre-excitation, bundle branch block, the presence of a pace-maker, the presence of an implanted automatic defibrillator, uncorrected hypokalaemia (potassium < 3.5 mmol/litre)
- •Insulin dependent diabetes mellitus
- •Significant liver disease (Aspartate Aminotransferase or Alanine Aminotransferase > twice the upper limit of reference range)
- •Significant renal disease (creatinine > 1.5 x upper limit of reference range)
- •Any clinical condition which in the opinion of the investigator, would preclude the safe fulfilment of the protocol and the safe administration of trial medication
- •Inability to perform repeated exercise testing due to extra-cardiac reasons
- •Concomitant treatment with any other anti-anginal medication, whether or not prescribed for this indication (e.g. calcium channel blockers, β-blockers or long-acting nitrates)
- •Concomitant treatment with anti-arrhythmic medication, digitalis or tricyclic anti-depressants or other agents known to affect ST-segment morphology
- •Known hypersensitivity to any of the components of the investigational drug
- •Pregnant or nursing women or women of child bearing potential
- •Participation in any other clinical trial within 2 months of enrolment
- •History of drug or alcohol abuse
研究组 & 干预措施
Lacidipine, low dose
Experimental
干预措施: Lacidipine, low dose (Drug)
Lacidipine, low dose
Experimental
干预措施: Placebo (Drug)
Lacidipine, medium dose
Experimental
干预措施: Lacidipine, medium dose (Drug)
Lacidipine, medium dose
Experimental
干预措施: Placebo (Drug)
Lacidipine, high dose
Experimental
干预措施: Lacidipine, high dose (Drug)
Placebo
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in total treadmill exercise duration
时间窗: Baseline, week 6
次要结局
- Consumption of short-acting nitrates(up to 6 weeks)
- Number of patients with adverse events(up to 6 weeks)
- Change in time to ST segment depression (≥ 0.1 mV)(up to 6 weeks)
- Treadmill exercise time to first report of anginal pain(week 6)
- Reason for termination of treadmill exercise test(up to 6 weeks)
- Frequency/severity of anginal attacks(up to 6 weeks)
研究者
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