NCT00171444已完成4 期
A 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 4,445
- 主要终点
- Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks
研究概览
简要总结
The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 patients >18 years of age
- •Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,
排除标准
- •• Severe hypertension, secondary hypertension, type 1 diabetes mellitus
- •History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks
次要结局
- Change from baseline systolic blood pressure after 8 weeks
- Change from baseline diastolic blood pressure after 8 weeks
- Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg
- Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg
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