NCT00304226已完成4 期
A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,288
- 试验地点
- 2
- 主要终点
- Blood pressure less than 140/90 mmHg after 14 weeks
研究概览
简要总结
The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.
The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2
排除标准
- •Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Blood pressure less than 140/90 mmHg after 14 weeks
次要结局
- Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks
- Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks
- Time when blood pressure reaches less than 140/90 mmHg
- Change in blood pressure at baseline, week 4, 8, 11, and 14
- Adverse events and serious adverse events at each study visit for 14 weeks
研究者
研究点 (2)
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