The Efficacy and Safety of Losartan/Hydrochlorothiazide Combination Drug (Preminent) in Patients With Morning Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Blood pressure level in the morning by blood pressure self-measurement
研究概览
简要总结
It is difficult to control morning hypertension in practical clinical situation. Angiotensin receptor blocker (ARB) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. However, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. The investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, Preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in Japanese. Patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. The efficacy and safety were compared after 3-month treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of outpatients with morning hypertension (135/85 mmHg)
- •Under treatment with any antihypertensive agents
排除标准
- •Poorly controlled hypertension (DBP>120 mmHg)
- •Poorly controlled diabetes (HbA1c>9.0%
- •Gout or hyperuricemia (UA>8.0 mg/dL)
- •Serum Cr>2.0 mg/dL
- •Serum K>5.5 mmol/L
- •Liver dysfunction (ALT>90 IU/L and/or g-GTP>14o IU/L)
- •Secondary hypertension
- •Patients who have contraindication for losartan and/or thiazide diuretics
研究组 & 干预措施
1. Preminent
Patients with blood pressure self-measurement-proven morning hypertension are treated with Preminent 1T qd for 3 months.
干预措施: Preminent (losartan/hydrochlorothiazide combination drug) (Drug)
2. High-dose losartan
Patients with blood pressure self-measurement-proven morning hypertension are treated with losartan 100 mg qd for 3 months.
干预措施: Preminent (losartan/hydrochlorothiazide combination drug) (Drug)
结局指标
主要结局
Blood pressure level in the morning by blood pressure self-measurement
时间窗: 3 months
次要结局
- Serum levels of potassium, BUN, Creatinine, Uric acid, and Brain natriuretic peptide(3 months)