NCT01213173已完成4 期
A Randomised, Open Label, Parallel Group, Multicentre, Phase IV Study on the Effect of 8 Weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on Heart Rate in the Stable Angina Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
研究概览
简要总结
The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Chinese patients
- •Heart rate ≥ 65bpm
- •Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
- •With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;
- •Has been on beta-blockers for at least 4 weeks*, on the dose equivalent to Betaloc ZOK® 23.75-47.5mg/day.
排除标准
- •Acute myocardial infarction within 6 months
- •Unstable angina or Prinzmetal's angina
- •II degree of AV block or greater
- •Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
- •Significant renal impairment (serum creatinine > 2.0 mg/dL)
- •Serum Alanine Aminotransferase or Aspartate Aminotransferase > 3 x upper limit of reference range
- •Serum potassium < 3.0 mEq/L
- •Serum sodium ≤ 130 mEq/L
- •Acute or chronic hepatitis or cirrhosis (clinical diagnosis)
- •Uncontrolled hyperthyroidism (clinical diagnosis)
- •Systolic blood pressure ≥ 180 mmHg, or < 100mmHg at enrolment
- •Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)
研究组 & 干预措施
1
Active Comparator
干预措施: Succinate Metoprolol (Betaloc ZOK®) (Drug)
2
Experimental
干预措施: Succinate Metoprolol (Betaloc ZOK®) (Drug)
结局指标
主要结局
The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
时间窗: After 8 weeks treatment in the study
Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.
次要结局
- The Impact on 24-hr Average Heart Rate From Baseline Within Groups(After 8 weeks treatment in the study)
- The Different Impact on 24-hr Average Heart Rate Between Two Groups(After 2 weeks treatment in the study)
- The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups(After 2 weeks treatment in the study)
- The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups(After 8 weeks treatment)
- The Difference of Change From Baseline in Total Ischemic Burden Between Groups(After 8 weeks treatment)
- The Difference of Change From Baseline in Angina Frequency Between Groups(After 8 weeks treatment)
- The Change From Baseline in Total Cholesterol(After 8 weeks treatment)
- The Change From Baseline in Fasting Plasma Glucose(After 8 weeks treatment)
- The Change From Baseline in Triglycerides(After 8 weeks treatment)
研究者
研究点 (1)
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