NCT02848170已完成不适用
An Exploratory Study of CS-3150 to Evaluate the Relation Between Antihypertensive Effect and Baseline Factors Compared to Olmesartan Medoxomil in Patients With Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change from baseline in 24 hr blood pressure
研究概览
简要总结
Phase 3 study to examine the relation between antihypertensive effect and baseline factors exploratively, compared to olmesartan medoxomil in patients with essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 and female subjects aged 20 years or older at informed consent
- •Subjects with essential hypertension during run-in period (mean 24 hour systolic blood pressure SBP ≥ 130 and diastolic blood pressure DBP ≥ 80 mmHg and Sitting systolic blood pressure (SBP) ≥ 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure (DBP) ≥ 90 mmHg and < 110 mmHg)
排除标准
- •Secondary hypertension or malignant hypertension
- •Diabetes mellitus with albuminuria
- •Serum potassium level < 3.5 or ≥ 5.1 milliequivalent (mEq)/L
- •Reversed day-night life cycle including overnight workers
- •estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^2.
研究组 & 干预措施
CS-3150
Experimental
CS-3150 2.5 to 5mg, orally, once daily after breakfast for 12 weeks
干预措施: CS-3150 (Drug)
olmesartan medoxomil
Active Comparator
olmesartan medoxomil 10 to 20 mg, orally, once daily after breakfast for 12 weeks
干预措施: olmesartan medoxomil (Drug)
结局指标
主要结局
Change from baseline in 24 hr blood pressure
时间窗: baseline to end of Week 12
Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and average blood pressure) and baseline factors frpm baseline to end of Week 12
次要结局
- Change from baseline in morning, evening, and night blood pressure.(baseline to week 12)
- Change from baseline in sitting blood pressure(baseline to week 12)
- Time course of 24 hr blood pressure and sitting blood pressure(week 12)
- Proportion of patients achieving 24 hr and sitting blood pressure control(week 12)
研究者
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