Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 441
- 主要终点
- Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
研究概览
简要总结
To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.
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 years or older
- •Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG
排除标准
- •Secondary hypertension
- •Malignant hypertension
- •Severe heart failure (NYHA III-IV)
- •History or evidence of renal disease
- •Recent history of myocardial infarction
- •Hypersensitivity to study drugs
- •History of drug or alcohol abuse
研究组 & 干预措施
1
oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks
干预措施: olmesartan medoxomil + hydrochlorothiazide, if necessary (Drug)
2
oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.
干预措施: losartan + hydrochlorothiazide, if necessary (Drug)
结局指标
主要结局
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
时间窗: 12 weeks
次要结局
- Change in mean sitting diastolic BP assessed by conventional BP measurements(after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks)
- Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP(after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks)