NCT00790946Unknown4 期
Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Blood Pressure, Adiponectin and PAI-1 concentration
研究概览
简要总结
The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment.
- Blood pressure control
- Changing of adiponectin and plasminogen activator inhibitor-1
- Influence metabolizing and cardiac function, etc.
详细描述
The primary endpoints are:
- blood pressure control
- Adiponectin and plasma type1 plasminogen active inhibitor
The secondary endpoints are
- HOMA-IR
- HbA1c
- TNF-α
- IL-6
- Plasma B-type natriuretic peptide
- LVMI
- E/A ratio
- Tei-index
- Apo-J
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out patients with hypertension male and female
- •Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg
- •Waist Surrounding diameter male≧85cm female≧90cm
- •Patient who is treating either high triglyceride,low HDL,or diabetes mellitus
- •Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl
- •Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB
排除标准
- •Patient who is using ACE-I and ARB
- •Serum creatinine ≧ 3 mg/dl
- •Liver impairment
- •History of allergy to valsartan
- •Pregnant women
- •Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety
研究组 & 干预措施
Valsartan
Active Comparator
Valsartan 80 to 160mg
干预措施: Valsartan (Drug)
结局指标
主要结局
Blood Pressure, Adiponectin and PAI-1 concentration
时间窗: 1 year
次要结局
- HOMA-IR(1 year)
- HbA1c(1 year)
- TNF-α(１ year)
- IL-6(1 year)
- BNP(1 year)
- LVMI(1 year)
- E/A ratio(1 year)
- Tei-index(1 year)
- Apo-J(1 year)
研究者
研究点 (1)
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