NCT00426478已完成4 期
The Comparison of the Antihypertensive Efficacy and Tolerability Between Valsartan Plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5mg in the Essential Hypertensive Patients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment
研究概览
简要总结
A double-blind, active-controlled, randomized trial to compare Valsartan plus Hydrochlorothiazide 80mg/12.5mg and Amlodipine 5 mg.
Study design: 2 weeks washout, 8 weeks treatment period.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patient with age ≧ 18 years old.
- •Patient with mild to moderate uncomplicated essential hypertension, and the blood pressure not adequately controlled on existing antihypertensive treatment.
- •Patient with sitting systolic blood pressure (sSBP)/ sitting diastolic blood pressure (sDBP) ≦ 180/110 mmHg at screening visit.
- •For non-diabetic patient, sitting systolic blood pressure (sSBP) ≧ 140 mmHg or sitting diastolic blood pressure (sDBP) ≧ 90 mmHg at baseline visit; for diabetic patient, sitting systolic blood pressure (sSBP) ≧ 130 mmHg or sitting diastolic blood pressure (sDBP) ≧ 80 mmHg at baseline visit.
- •Patient or his/her legally acceptable representative has signed and dated the informed consent form.
排除标准
- •Known or suspected secondary hypertension.
- •sSBP > 180 mmHg or sDBP > 110 mmHg at baseline visit.
- •Patients taking more than two anti-hypertensive medications at the screening visit. (Fixed-dose combinations of two or more antihypertensive therapies will be counted as two or more antihypertensive medications.)
- •Known NYHA functional class Chronic Heart Failure (CHF) III and IV.
- •With a history of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 6 months, clinically significant valvular heart disease, or hepatic and/or renal dysfunction as defined by the following laboratory parameters
- •SGPT (ALT) or SGOT (AST) > two times upper the limit of normal range
- •Serum creatinine > 2.3 mg/dl or creatinine clearance < 30 ml/min
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks treatment
次要结局
- Change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks treatment
- Change from baseline in Ambulatory Blood Pressure Measurement (ABPM) parameters after 8 weeks treatment
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt NephropathyDiabetic NephropathiesHypertensionNCT00153023Boehringer Ingelheim885
已完成
4 期
Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive AdultsHypertensionNCT00439738Novartis Pharmaceuticals412
已完成
4 期
Hypertension and Cardiovascular Risk FactorsHYPERTENSIONNCT00171782Novartis76
已完成
不适用
Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake PopulationHypertensionNCT02255253The George Institute for Global Health, China1,410
已完成
4 期
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic HypertensionStage 2 Systolic HypertensionNCT00931710Novartis488