A Multicenter, Non-comparative, Phase IV Study to Evaluate the Effect of Candesartan Based Therapy in the Percent Change of proBNP Level After 24 Week Treatment in the Patients With Hypertension With Left Ventricular Hypertrophy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Percent Change of B Type Natriuretic Peptides (BNP) Level
研究概览
简要总结
The purpose of this study is to investigate effect of candesartan based therapy on percent change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left ventricular hypertrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Hypertension with diastolic blood pressure within 95-115 mm/Hg or/and systolic blood pressure within 160-200 mm/Hg
- •Patients diagnosed as left ventricular hypertrophy by electrocardiogram
排除标准
- •Secondary hypertension
- •History of myocardial infarction
- •Stroke within the previous 6 months
研究组 & 干预措施
Candesartan
Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
干预措施: Candesartan (Drug)
Candesartan
Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
干预措施: Felodipine (Drug)
结局指标
主要结局
Percent Change of B Type Natriuretic Peptides (BNP) Level
时间窗: At Baseline and 24 weeks
Change of B Type Natriuretic Peptides Level of the Subjects With Hypertension and Left Ventricular Hypertrophy (LVH) Treated With Candesartan Based Therapy for 24 Weeks was calculated just as the later time point minus the earlier time point. No specific calculation was used.
次要结局
- Change of Diastolic Blood Pressure (DBP)(At Baseline and 24 weeks)
- LVH(Left Ventricular Hypertrophy) Regression by Echocardiac Parameter, Left Ventricular Mass Index(At Baseline and 24 weeks)
- Change of Systolic Blood Pressure (SBP)(At Baseline and 24 weeks)
- Percent Change of proBNP(B Type Natriuretic Peptides) in Patients Treated With Candesartan Only(At Baseline and 24 weeks)
- Percent Change of proBNP(B Type Natriuretic Peptides) in Patients With Candesartan Plus Felodipine(At Baseline and 24 weeks)