NCT00241137已完成3 期
A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 3,790
- 试验地点
- 1
- 主要终点
- Change from baseline diastolic blood pressure after 4 weeks
研究概览
简要总结
The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives
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
- 是
入选标准
- •• Male or female age between 18-80 years of age, inclusive
- •Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP >= 95 and =< 109 mmHg for non treated patients.
- •Previously treated patients should have a MSDBP =< 109 mmHg at visit 1 and a MSDBP >= 95 and =< 109 mmHg at visit
- •Written informed consent to participate in the study prior to any study procedures
- •Ability to communicate and comply with all study requirements
排除标准
- •Severe hypertension (grade 3 of WHO classification; >= 110 mmHg diastolic and/or >= 180 mmHg systolic).
- •Malignant hypertension
- •Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
- •Known history of proteinuria (greater than 0.3 gram per day)
- •Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
- •Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit
- •Transient ischemic cerebral attack during the last 12 months prior to Visit 1.
结局指标
主要结局
Change from baseline diastolic blood pressure after 4 weeks
次要结局
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks
- Adverse events and serious adverse events at each study visit for 4 weeks
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effects of Continuous Positive Airway Pressure and Valsartan Treatments on Arterial Blood Pressure in OSAS PatientsHypertension,Obstructive Sleep ApneaNCT00409487University Hospital, Grenoble60
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
3 期
Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan AloneHypertensionNCT00170989Novartis2,714
已完成
4 期
Safety and Efficacy of Valsartan Plus Hydrochlorothiazide and Amlodipine in Hypertensive PatientsHypertensionNCT00426478Novartis80