NCT00367978已完成4 期
A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes
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
- 275
- 试验地点
- 2
- 主要终点
- Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.
研究概览
简要总结
This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African-American
- •males and females
- •current diagnosis of type 2 diabetes documented by medical history;
- •mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;
- •HbA1C ≤ 9.5%
排除标准
- •having unilateral or bilateral renal artery stenosis;
- •having clinically significant cardiac dysrhythmias;
- •having a significant history of coronary artery disease within the past 6 months;
- •having a history or diagnosis of congestive heart failure (CHF);
- •having any clinically relevant cardiac valvular disease
结局指标
主要结局
Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.
次要结局
- change from baseline in sitting diastolic BP at Week 24
- change from baseline in sitting systolic BP at Week 24
- change from baseline in urinary protein excretion at Week 24
- change from baseline in HbA1c at Week 24
- change from baseline in estimated glomerular filtration rate (EGFR) at Week 24
研究者
研究点 (2)
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