A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 932
- 试验地点
- 2
- 主要终点
- Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
研究概览
简要总结
This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written informed consent
- •Male or female ages 18 or older and less than 86 years
- •Diagnosed as having essential diastolic hypertension, as follows:
- •Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and < 100 mmHg
- •At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP >=90 mmHg and <110 mmHg
排除标准
- •Severe hypertension
- •Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
- •Malignant hypertension
- •Administration of any agent indicated for the treatment of hypertension after Visit 1
- •Known moderate or malignant retinopathy.
- •Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
- •History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
- •History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
- •Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Valsartan 160 mg
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
干预措施: Valsartan 160 mg (Drug)
Valsartan 160 mg
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
干预措施: Placebo (Drug)
Valsartan/amlodipine 160/5 mg
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks
干预措施: Valsartan/amlodipine 160/5 mg (Drug)
Valsartan/amlodipine 160/5 mg
One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks
干预措施: Placebo (Drug)
Single-Blind Run-In Valsartan 160 mg
Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
干预措施: Valsartan 160 mg (Drug)
结局指标
主要结局
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
时间窗: Baseline and Week 8
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.
次要结局
- Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint(Baseline and Week 8)
- Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint(Baseline and Week 8)
- Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint(Week 8)
- Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint(Week 8)