NCT00350168已完成3 期
An 8-week Multicenter Study to Evaluate the Efficacy and Safety of Orally Administered Valsartan/Amlodipine Combination Based Therapy Versus Amlodipine Monotherapy in Patients With Stage II Hypertension
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
- 647
- 试验地点
- 2
- 主要终点
- Change from baseline in MSSBP at week 4
研究概览
简要总结
The purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage II hypertensive patients (MSSBP ≥ 160 mmHg).
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
- •18 years of age or older.
- •Moderate to severe high blood pressure. This is defined as a systolic pressure (the top number) greater than or equal to 160 mmHg and less than 200 mmHg.
排除标准
- •History of allergy or hypersensitivity to ARBs, CCBs, thiazide diuretics
- •Inability to stop all prior blood pressure medications safely
- •Systolic BP ≥ 200 mmHg and/or diastolic BP ≥ 120 mmHg
- •Controlled blood pressure (systolic BP < 140 mmHg) taking more than 3 antihypertensive medications at screening
- •Systolic BP ≥ 140 mmHg and < 180 mmHg taking more than two antihypertensive medications at screening
- •Systolic BP ≥ 180 mmHg taking more than one antihypertensive medication at screening
- •History of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina
- •Type 1 diabetes
- •Poorly controlled Type 2 diabetes
- •History of heart failure
- •Arrhythmia
- •Significant valvular heart disease
- •Active gout
- •History of autoimmune diseases
- •History of multiple drug allergies
- •Liver disease
- •Pancreatic injury within 1 year of screening
- •Evidence of kidney impairment or history of dialysis
- •Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. This could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction.
- •Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, would be excluded UNLESS they are post-menopausal, surgically sterile OR are using acceptable methods of contraception. The use of hormonal contraceptives is not allowed
- •Pregnant or nursing (lactating) women
- •History of malignancy of any organ system within the past five years
- •Any severe, life-threatening disease within the past five years
- •History of drug or alcohol abuse within the last 2 years.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Change from baseline in MSSBP at week 4
次要结局
- Evaluation of safety and tolerability after 8 weeks of treatment
- Change from baseline MSSBP after 2 and 8 weeks of treatment
- Proportion of patients reaching overall BP control (MSSBP < 140 mmHg and MSDBP < 90mmHg) after 8 weeks of treatment
- Change from baseline MSDBP after 2, 4 and 8 weeks of treatment
研究者
研究点 (2)
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