A Randomized, Double-blind, Parallel Group, Active-controlled, 38-week Study to Evaluate the Efficacy of Valsartan Versus Amlodipine on the Arterial Properties of Postmenopausal Women With Mild to Moderate Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)
研究概览
简要总结
The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women
- •Mild to moderate hypertension
- •Statin therapy or LDL≤ 4.1 mmol/L
排除标准
- •Severe hypertension
- •LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication
- •Certain hormonal therapy
- •History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
- •Liver, kidney, or pancreas disease
- •Raynaud's disease or any other significant peripheral vascular disease
- •Allergy to certain medications used to treat high blood pressure
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Valsartan 320 mg
干预措施: Valsartan 320 mg (Drug)
Valsartan 320 mg
干预措施: Hydrochlorothiazide (Drug)
Amlodipine 10 mg
干预措施: Amlodipine 10 mg (Drug)
Amlodipine 10 mg
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change From Baseline to Week 38 in the Carotid-femoral Pulse Wave Velocity (PWV)
时间窗: Baseline and Week 38
PWV was determined from transcutaneous Doppler flow recordings and the foot-to-foot method triggered by the simultaneous ECG. Two simultaneous Doppler flow tracings were taken at the left common carotid and the right femoral artery in the groin with a linear array probe. The time delay (t) was measured between R wave of the ECG and the base of the flow waves recorded at these points, and averaged over 10 beats. The distance (D) traveled by the pulse wave was measured over body surface as the distance from the suprasternal notch to the carotid artery. PWV was calculated as PWV=D/t.
次要结局
- Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Week 12(Baseline and Week 12)
- Change From Baseline in Post-ischemic Forearm Skin Reactive Hyperemia at Endpoint (Week 38)(Week 38)
- Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at Week 12(Baseline and Week 12)
- Change From Baseline for Endothelial Function Measured by Brachial Artery Flow-mediated Vasodilatation (FMD) Using the Brachial Artery Reactivity Test (BART) at End-point (Week 38)(Baseline and Week 38)
- Changes in Mean Left Carotid Distensibility at Week 12(Baseline and Week 12)
- Changes in Mean Left Carotid Distensibility at Week 38(Baseline and Week 38)
- Changes in Mean Right Carotid Distensibility at Week 12(Baseline and Week 12)
- Changes in Mean Right Carotid Distensibility at Week 38(Baseline and Week 38)
- Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 12(Baseline and Week 12)
- Changes in Baroreflex Sensitivity as it Relates to Changes in Carotid Distensibility From Baseline to Week 38(Baseline and Week 38)
- Change in Left Ventricular Mass Index (LVMI) and Diastolic Function Using Echocardiography From Baseline to Week 38(Baseline and Week 38)
- Changes in Central Blood Pressure, Evaluated by Applanation Tonometry From Baseline at Weeks 12 and 38(Baseline, Week 12 and Week 38)