NCT01970059Unknown3 期
Efficacy and Safety Comparison of Extended-Release Carvedilol Sulfate and Sustained-release Metoprolol Succinate in Patients With Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 302
- 试验地点
- 11
- 主要终点
- Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
研究概览
简要总结
The aim of present study is to evaluate the efficacy and safety of Extended-Release Carvedilol Sulfate versus in Patients With Mild or Moderate Primary Hypertension
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females
- •Aged from 18 to 70 years
- •Had a history of essential hypertension
- •Average sitting diastolic blood pressure≧90mmHg，but≦109mmHg
排除标准
- •Malignant hypertension
- •Average sitting systolic blood pressure≧180mmHg
- •Type 2 diabetes with hemoglobin A1c≥9%
- •Type 1 diabetes
- •New York Heart Association class Ⅱ-Ⅳ congestive heart-failure
- •Unstable angina
- •Second or third degree heart block or history of sick sinus syndrome unless a pacemaker was in place
- •Atrial fibrillation
- •Bradycardia (<60 bpm, seated)
- •Asthma or other obstructive pulmonary disease
- •History of myocardial infarction
- •Stroke in the 6 months before screening
- •Known contraindications to β-adrenergic blocker therapy
- •Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>3 times upper limit of normal
- •Crea>2 times upper limit of normal
- •Pregnancy or lactation
研究组 & 干预措施
Extended-Release Carvedilol Sulfate
Experimental
18-72mg/d,po
干预措施: Extended-Release Carvedilol Sulfate (Drug)
Sustained-release Metoprolol Succinate
Active Comparator
47.5-190mg/d,po
干预措施: Sustained-release Metoprolol Succinate (Drug)
结局指标
主要结局
Mean Change From Baseline in Sitting Diastolic Blood Pressure (sDBP) at Week 8
时间窗: Baseline and Week 8
次要结局
- Mean Change From Baseline in Sitting Systolic Blood Pressure (sSBP) at Week 8(Baseline and Week 8)
- Proportion of Patients With Sitting Systolic Blood Pressure <140 mm Hg and Sitting Diastolic Blood Pressure <90 mm Hg at Week 8(Week 8)
研究者
研究点 (11)
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