NCT02177448已完成3 期
A Double-blind, Parallel-group Comparison Study of BIBR 277 Capsule in Patients With Essential Hypertension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 主要终点
- Antihypertensive effect
研究概览
简要总结
The efficacy and safety of Telmisartan capsule in patients with essential hypertension were evaluated in comparison with Enalapril Maleate in the double blind 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
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 25 years of age
- •Patient is either male or female
- •Outpatient. Change to inpatient is not allowed during the study period
- •Blood pressure is measured 3 times or more during the 4-week observation period; the last 2 measurements in the sitting position (intervals between measurements must be less than 4 weeks) are stabilized for both of systolic pressure (within +/- 30 mmHg) and diastolic pressure within +/- 15 mmHg) with the mean exceeding 160 mmHg for systolic and 95 mmHG for diastolic pressure
排除标准
- •Patient has severe hypertension (the last 2 measurements in the observation period exceed 120 mmHg in terms of diastolic blood pressure)
- •Patient has secondary or malignant hypertension
- •Patient has a history of severe cardiac failure, unstable angina, or myocardial infarction within previous six months
- •Patient has atrioventricular conduction disturbance, atrial fibrillation or severe arrhythmia
- •Patient has any symptoms of cerebrovascular disorder
- •Patient has serious hepatic dysfunction (either GOT (glutamic-oxaloacetic transaminase) or GPT (glutamic-pyruvic transaminase) exceeds 100 U)
- •Patient has renal dysfunction (serum creatinin ≥ 2.1 mg/dl)
- •Patient has uncontrolled diabetic (either of the following tests exceeds the specified standards: fasting blood glucose exceeding 151 mg/dl or HbA1c exceeding 8%)
- •Patient has a history of drug sensitivity to ACE (angiotensin converting enzyme) inhibitors and angiotensin II receptor antagonists
- •Patient has a history of angioedema due to ACE inhibitors
- •Patient has hyperkalemia (K exceeding 5.5 mEq/l)
- •Patient has received enalapril just before the start of observation period
- •Patient has received treatment with any other investigational drug(s) within three months of the start of observation period
- •Patients is pregnant, breast-feeding, or possible pregnant, or wants to be pregnant during the study period
- •Patient has any other condition that the investigator or subinvestigator feels would be inappropriate for the study participation
研究组 & 干预措施
Enalapril and placebo matching BIBR277
Active Comparator
干预措施: Placebo matching BIBR277 (Drug)
BIBR277 and placebo matching enalapril
Experimental
干预措施: BIBR277 low dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
干预措施: BIBR277 medium dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
干预措施: BIBR277 high dose (Drug)
BIBR277 and placebo matching enalapril
Experimental
干预措施: Placebo matching enalapril (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
干预措施: Enalapril low dose (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
干预措施: Enalapril medium dose (Drug)
Enalapril and placebo matching BIBR277
Active Comparator
干预措施: Enalapril high dose (Drug)
结局指标
主要结局
Antihypertensive effect
时间窗: every 2 weeks up to week 12
次要结局
- Decrease in blood pressure (mean systolic and diastolic blood pressure)(every 2 weeks up to week 12)
- Rate of normalized blood pressure(every 2 weeks up to week 12)
- Occurrence of the adverse event cough(up to 12 weeks)
研究者
相似试验
已完成
4 期
1 Year Trial Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt NephropathyDiabetic NephropathiesHypertensionNCT00153023Boehringer Ingelheim885
已完成
3 期
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate HypertensionHypertensionNCT00133185Boehringer Ingelheim31
已完成
不适用
Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake PopulationHypertensionNCT02255253The George Institute for Global Health, China1,410
已完成
不适用
Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk HypertensivesObesityHypertensionNCT00539487Boehringer Ingelheim5,827
已完成
4 期
Effectiveness of MICARDIS® (Telmisartan) on Blood Pressure Control and Quality of Live in Patients With Essential HypertensionHypertensionNCT02242370Boehringer Ingelheim3,045