NCT00154271已完成4 期
Effects of Blood Pressure Reduction on High Sensitivity C-Reactive Protein (hsCRP)
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
- 1,677
- 主要终点
- Change from baseline to Week 6 in mean sitting blood pressure (SD)
研究概览
简要总结
The study compares the efficacy of an aggressive versus a moderate initial antihypertensive regimen to reduce blood pressure in patients with Stage 2 hypertension. Additionally, the study examines the effects of blood pressure reduction on the levels of high sensitivity hsCRP. Although the main goal is to determine the overall effect of blood pressure reduction on hsCRP levels, analysis will also evaluate whether an aggressive antihypertensive regimen is more effective than a moderate one in reducing hsCRP levels.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 2 hypertension as defined by the mean of three (3) repeated seated BP measurements of: SBP of 160 to 185 mmHg, inclusive and/or DBP of 100 to 109 mmHg, inclusive.
- •Patients must have documentation of serum creatinine equal or <2.0 mg/dL, serum potassium equal or >3.5 and equal or <5.5 mmol/L, and serum AST or ALT <2xULN obtained within 3 months prior to Visit
- •Patients must have documentation of HbA1C equal or <11.0 % obtained within 1 month prior to Visit 1.
排除标准
- •History of secondary hypertension.
- •Pharmacologic antihypertensive therapy with ACE inhibitors, angiotensin receptor blockers, or aldosterone blockers within 3 months prior to Visit 1, or with thiazide diuretics within 1 month prior to Visit
- •The use of other classes of agents which lower BP but are being used for other therapy or for HTN, are allowed as long as these agents are started at least 3 months prior to randomization, are not initiated after enrollment and doses remain unchanged during the study.
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Change from baseline to Week 6 in mean sitting blood pressure (SD)
Change from baseline to Week 12 in median plasma hsCRP
Change from baseline to Week 6 in median plasma hsCRP
次要结局
- Change in mean sitting DBP
- Proportion of responders with change in systolic BP
- Change in hsCRP for subjects with baseline hsCRP greater or equal to 3.0 mg/L
- Time to first SBP reduction
- Proportion of subjects achieving SBP control
研究者
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