JPRN-UMIN000016629进行中（未招募）未知
Comparative effects on nocturnal hypertension at home by combination therapy of ARB/CCB and ARB/diuretics
Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine/ SHIONOGI&CO.,LTD.0 个研究点目标入组 400 人开始时间: 2015年2月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30years-old 至 85years-old（—）
- 性别
- All
入选标准
- •At interim registration:
- •Patients whose profiles are fulfilled with all of the following criterias will be included.
- •1) patients who give written consent to participation in the study at their own will
- •2) at the age of 30 years old or older and younger than 85 years old (at consent acquisition)
- •3) male or female (except females with possibility of pregnancy)
- •4) outpatient
- •5) hypertensive patients
- •Untreated patients*1 and patients*2 treated with antihypertensive drugs
- •*1:Patients with office BP >=140mmHg in SBP or 90mmHg in DBP ( home BP >=135mmHg in SBP or 85mmHg in DBP),
- •*2: Patients treated concomitantly with two drugs among ARB, CCB anddiuretics et al. (including fixed-dose combination drugs with two component) or single drug at doses less than ordinary doses instructed in the package inserts for Japanese
- •6) The patients who can accept irbesartan, trichlormethiazide and amlodipine
- •At the official registration
- •1)The patients whose mean nocturnal blood pressure measured during five days before hospital visiting at week4 are higher than SBP120mmHg or DBP70mmHg
排除标准
- •Patient who concern the following criterias are excluded:
- •At interim registration:
- •1)patient in being treated with irbesartan
- •2) patient with severe kidney dysfunction(serum creatinine >= 2.0 mg/dL )
- •3) patient with severe liver dysfunction(incliding biliary cirrhosis or cholestasis band)
- •4) patient with severe heart failure(New York Heart Association(NYHA) functional class >=II M )
- •5)patient diagnosed the ischemic heart disease or stroke within the past 6 months before consent acquisition
- •6) patient with history of hypersensitivity to ARB, thiazide drugs ,CCB and these combination drugs
- •7) patient with hypokalemia(K<3.0mEq/L) or hyperkalemia(K>=5.5mEq/L)
- •8) patients with malignant tumor or the history of malignant tumor within the past 5 years before consent acquisition)
- •9) pregnant woman or woman with possibility of being pregnant.
- •10) patient with sleep apnea syndrome
- •11) patient with not-well controlled hypertension(SBP>=200mmHg or DBP>=120mmHg at office)
- •12) patient deemed ineligible by investigator
- •At official registration
- •1)patient who is deemed ineligible by investigator from implemental status in monitoring by the use of 3G-enabled BPM with MedicalLINK high blood management service during observation period
- •2) patient with serious adverse events during the observation period
- •3) patient deemed ineligible by investigator
研究者
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