A Single Center, Randomized, Double-blind, Active Controlled, Parallel Group Study to Demonstrate Non-inferiority of a Fixed Dose Combination of 5 mg Amlodipine and 80 mg Valsartan to 160 mg Valsartan in the Treatment of Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 主要终点
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
研究概览
简要总结
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
- •High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.
排除标准
- •Known or suspected secondary hypertension
- •Known New York Heart Association (NYHA) functional class IV Heart Failure
- •History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
- •Clinically significant valvular disease
- •Women who are pregnant, intend to become pregnant or are breastfeeding
- •Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
- •Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Amlodipine 5mg/Valsartan 80 mg
During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
干预措施: Amlodipine 5mg/Valsartan 80 mg (Drug)
Valsartan 160 mg
In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
干预措施: Valsartan (Drug)
Run-In Valsartan 80 mg
During run-in period, oral valsartan 80 mg once daily for 4 weeks.
干预措施: Valsartan (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement
时间窗: Baseline and 8 weeks
Two 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 mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement
时间窗: Baseline and 8 weeks
Two 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 mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.
次要结局
- Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase(Baseline and 8 weeks)
- Number of Participants With Adverse Events During Double-blind Phase(8 weeks)
- Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours(Baseline and 8 weeks)