Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 417
- 主要终点
- Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
研究概览
简要总结
To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 or older
- •Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg
排除标准
- •Secondary hypertension
- •Malignant hypertension
- •Severe Heart Failure (NYHA III-IV)
- •Recent history of myocardial infarction
- •Hypersensitivity to study medications
- •History of drug or alcohol abuse
- •History or evidence of renal disease
研究组 & 干预措施
1
oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP
干预措施: olmesartan medoxomil + hydrochlorothiazide, if necessary (Drug)
2
oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP
干预措施: nitrendipine + hydrochlorothiazide, if necessary (Drug)
结局指标
主要结局
Change in mean sitting systolic blood pressure as assessed by conventional BP measurements
时间窗: 12 weeks
次要结局
- Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP(after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment)
- Change in mean sitting systolic blood pressure assessed by conventional BP measurements(After 1, 2, 4, 8, 12, 16, 20, and 24 weeks)