NCT01828359已完成4 期
An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy
Hanmi Pharmaceutical Company Limited0 个研究点目标入组 199 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 主要终点
- Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
研究概览
简要总结
The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.
详细描述
- Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
- Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
- Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 aged or over
- •Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
- •Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)
排除标准
- •Patients with too high Blood pressure
- •≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
- •History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
- •Secondary hypertension or suspected to be
研究组 & 干预措施
Amosartan® tab
Experimental
Amlodipine 5mg /Losartan 100mg
干预措施: Amosartan® tab (Drug)
Cozaar® plus pro tab
Active Comparator
Losartan 100mg/ HCTZ 12.5mg
干预措施: Cozaar® plus pro tab (Drug)
结局指标
主要结局
Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)
时间窗: Baseline, Week 8
次要结局
- Change from baseline in MSDBP(Baseline, week 4)
- Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)(Baseline, Week 4 and 8)
- Blood pressure responder rate(Baseline, Week 4 and 8)
研究者
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