An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
研究概览
简要总结
This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
- •Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
- •Patients with Left Ventricular Hypertrophy
排除标准
- •Severe hypertension
- •Symptomatic heart failure
- •History of stroke, heart attack, coronary bypass surgery etc.
- •Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Amlodipine + Valsartan
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
干预措施: Valsartan (Drug)
Amlodipine + Valsartan
Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
干预措施: Amlodipine (Drug)
Losartan + Hydrochlorothiazide
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
干预措施: Hydrochlorothiazide (Drug)
Losartan + Hydrochlorothiazide
Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
干预措施: Losartan (Drug)
结局指标
主要结局
Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
时间窗: Baseline to week 52
次要结局
- Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI(Baseline to week 52)
- Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)(Baseline to week 52)
- Percentage of Participants Achieving Target Blood Pressure at Week 52(Week 52)
- Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI(Baseline to week 52)
- Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)(Baseline to week 52)
- Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI(Baseline to week 52)
- Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI(Baseline to week 52)
- Percentage of Participants Who Experienced Adverse Events (AEs)(Baseline to week 52)