NCT02187484已完成2 期
BIBR 277 Capsules Clinical Study on Hypertension With Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
研究概览
简要总结
The antihypertensive effect, safety and usefulness of treatment with BIBR 277 capsules were evaluated in hypertensive patients with nephropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Condition: Either of the following criteria is satisfied in laboratory tests:
- •Presence of a renal parenchymal disorder such as chronic glomerulonephritis is confirmed (serum creatinine < 3.0 mg/dL)
- •Presence of a renal function disorder (serum creatinine ≥ 1.5 mg/dL to < 3.0 mg/dL)
- •Age: ≥ 20 years
- •Sex: Either male or female
- •Patient status: Either outpatients or inpatients. However, the patient status should remain unchanged throughout the study period
- •Blood pressure (BP):
- •[Outpatients] The last 2 measurements of sitting BP out of at least 3 taken during the observation period (2 - 4 weeks) should be stable and a mean of the two measurements should be ≥160 mmHg for systolic BP (SBP) and ≥95 mmHg for diastolic BP (DBP)
- •[Inpatients] The last 2 measurements of supine BP taken during the observation period (1 week) should be stable and a mean of the 2 measurements should be ≥ 150 mmHg for SBP and ≥ 90 mmHg for DBP
排除标准
- •Renovascular hypertension
- •Undergoing haemodialysis
- •Severe hypertension (Diastolic BP ≥ 120 mmHg)
- •Severe heart failure, angina pectoris, or history of myocardial infarction
- •Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
- •Symptoms of cerebrovascular disorder
- •Serious hepatic dysfunction
- •Uncontrolled diabetes
- •Peptic ulcer
- •History of hypersensitivity to drugs
- •Hyperkalaemia
- •Undergoing treatment with a digitalis preparation
- •Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
- •Otherwise judged ineligible by the investigator
研究组 & 干预措施
Single rising doses of BIBR 277
Experimental
干预措施: BIBR 277 (Drug)
结局指标
主要结局
Changes from baseline in hypertensive effect by investigator, using a 5-grade classification
时间窗: 8 weeks after start of treatment
次要结局
- Usefulness assessment by investigator, using a 5- grade classification(8 weeks after start of treatment)
- Number of patients with abnormal changes in laboratory values(Up to 8 weeks after start of treatment)
- Changes from baseline in blood pressure reduction(8 weeks after start of treatment)
- Overall safety assessment by investigator, using a 5- grade classification(8 weeks after start of treatment)
- Changes from baseline in blood pressure / pulse rate(8 weeks after start of treatment)
- Number of patients with adverse events(Up to 12 weeks)
- Rate of blood pressure normalisation(8 weeks after start of treatment)
研究者
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