NCT00171080已完成3 期
A 2 x 5-week Multicenter, Cross-over Study to Compare the Reduction of Predialysis Systolic Blood Pressure With Valsartan 80 mg Compared to Irbesartan 150 mg in Patients With Mild to Moderate Hypertension on Long-term Hemodialysis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change from baseline in systolic blood pressure after 4 weeks
研究概览
简要总结
The purpose of the study is to compare the efficacy, safety and tolerability of valsartan 80 mg (with a starting dose of 40 mg) to irbesartan 150 mg (with a starting dose of 75 mg) in patients on long-term haemodialysis with mild to moderate increased mean supine systolic blood pressure (MSSBP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild and moderate hypertension defined by a MSSBP ≥ 140 mmHG and < 180 mmHG at Visits 1 and 2 for treated and untreated patients
- •Chronic hemodialysis for at least 6 months prior to Visit 1 as substitution therapy.
- •If treated with epoetin: patients with a stable hematocrit ≤ 40% (± 5%).
排除标准
- •Inability to discontinue angiotensin II receptor blockers (ARBs) safely for a period of 1 week, as required by the protocol.
- •Treatment with more than 3 different compounds for the treatment of hypertension at Visit
- •Atrial fibrillation
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change from baseline in systolic blood pressure after 4 weeks
次要结局
- Adverse events and clinical laboratory abnormal results
- Systolic blood pressure less than 100 mmHg with or without symptoms of low blood pressure
- Change from baseline in daytime and nighttime ambulatory blood pressures after 4 weeks
- Change from baseline in diastolic blood pressure after 4 weeks
- Change from baseline in average 24-hour ambulatory blood pressure after 4 weeks
研究者
研究点 (2)
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