A Randomized, Open-label, Comparative, Non-inferiority, Multicenter Study to Compare Efficacy of Losartan Potassium Group and Carvedilol Group on Arterial Stiffness in Essential Hypertension Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 201
- 主要终点
- Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
研究概览
简要总结
The primary objective of this study is to evaluate efficacy, arterial stiffness measured by Pulse Wave Velocity (PWV) of Losartan potassium group compared to Carvedilol group after 24 weeks of treatment in patients with the essential hypertension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female adults, 18 years or over
- •Essential Hypertension with mean SBP (systolic blood pressure) ≥ 140 mm Hg or mean DBP (diastolic blood pressure) ≥ 90 mm Hg* when blood pressure is measured at Visit 1(week -2) and at Visit 2(week 0).
- •If diabetes patients, mean SBP ≥ 130 mm Hg or mean DBP ≥ 80 mm Hg (Mean of blood pressure values measured consecutively at least 2 minutes apart)
- •Patient who is willing to, and is able to sign the informed consent form
排除标准
- •Patient Is Pregnant Or Breastfeeding, Or Expecting To Conceive Within The Projected Duration Of The Study
- •Patient Has Known Or Suspected Secondary Hypertension Of Any Etiology
- •Patient has history of malignant hypertension
- •Patient has history of cerebrovascular accident (cerebral infarction) or myocardiac infarction within the last 6 months
- •Patient takes antihypertensive drugs
研究组 & 干预措施
1
Losartan or Losartan/HCTZ
干预措施: losartan potassium (Drug)
结局指标
主要结局
Pulse Wave Velocity (PWV) Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
时间窗: Baseline and 24 Weeks
Analysis was performed in the modified intention to treat (mITT) population.
PWV Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug
时间窗: Baseline and 24 Weeks
Analysis was performed in the per protocol (PP) population which additionally excludes certain protocol violations as described in the analysis plan.
次要结局
- Diastolic Blood Pressure (DBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug(Baseline and 24 weeks)
- Systolic Blood Pressure (SBP) Mean Changes From Baseline (Visit 2) to 24 Weeks (Visit 6) After the Administration of the Study Drug(Baseline and 24 weeks)