A National, Multicentric and Comparative Study to Evaluate Efficacy and Tolerability of the Association of Valsartan and Amlodipine Versus Amlodipine Alone in the Treatment of Essential Arterial Hypertension - Stages I and II (Mild to Moderate).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 551
- 试验地点
- 1
- 主要终点
- Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
研究概览
简要总结
The objective of this study is to evaluate efficacy, safety and tolerability of the valsartan+amlodipine association in patients with mild to moderate essential hypertension, in comparison to amlodipine alone.
Patients should have mild to moderate essential hypertension [grades 1 and 2 of WHO classification (8)]. The diastolic blood pressure threshold for inclusion in this study is 95 mmHg, as these patients are more likely to benefit from association therapy than patients with lower diastolic blood pressure.
For safety reasons, patients with severe hypertension (grade 3 of WHO classification) will not be included in this study. Moreover, patients developing severe hypertension (MSDBP > 110 mmHg and/or MSSBP > 180 mmHg) during the open-label treatment phase will be discontinued from the study.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incl- Patients with mild to moderate essential hypertension (grade 1 and 2 of WHO classification).
- •- Patients with essential diastolic hypertension measured by a standard aneroid or mercury column sphygmomanometer showing MSDBP > 95 mmHg and < 110 mmHg and MSSBP <180 mmHg.
排除标准
- •Severe hypertension (grade 3 of WHO classification: DBP >= 110 mmHg and/or SBP ≥ 180 mmHg) or malignant hypertension.
- •Inability to completely discontinue all antihypertensive medications safely for a period of at least 2 weeks as required by the protocol.
- •Evidence of a secondary form of hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
结局指标
主要结局
Change from baseline in the mean sitting diastolic blood pressure after 8 weeks
次要结局
- Change from baseline in the mean sitting systolic blood pressure from baseline after 8 weeks
- Adverse events after 8 weeks
- Change from baseline in standing blood pressure and heart rate after 8 weeks