NCT01335984已完成不适用
A Multi-center, Randomized, Parallel, Interventional, Open Label Trial to Compare the Blood Pressure-lowering Effect of Conventional Treatment and Smart Care Service in Hypertensive Patients Receiving Any Conventional Treatment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 440
- 试验地点
- 3
- 主要终点
- Clinic blood pressure
研究概览
简要总结
This is a multi-centered, randomized, parallel group, interventional & open label clinical trial accessing efficacy of intervention effect by smart care system over existing treatment group for lowering blood pressure of hypertension patients taking anti-hypertension drug.
详细描述
- Objectives : To evaluate superiority in blood pressure lowering effect of the Smart Care Service compared to the conventional treatment in hypertensive patients receiving any conventional antihypertensive medication
- Test and control group
- Control group : The subject group who is receiving any conventional treatment (hospital visit).
- Test groups
Conventional treatment + remote monitoring group:
The subject group who is receiving the health care services using conventional treatment (hospital visit) and remote monitoring.
Remote visit + remote monitoring group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients who are able to receive outpatient treatment from over 20 to under 70 years of age.- Over SBP 140mmHg without diabetes or renal failure
- •Patients who are taking more than one kind of any antihypertensive medications
- •Systolic blood pressure (SBP) ≥ 140mmHg in patient with diabetes mellitus and renal disease or
- •Systolic blood pressure (SBP) ≥ 130mmHg in patient without diabetes mellitus and renal disease
- •Patients who are able to understand the purpose of this trial and to read and write
- •Patients who are able to use Smart Care PC for this trial
- •Patients who participate voluntarily and sign the informed consent
排除标准
- •Patients with severe hypertension (mean of two seated SBP ≥200 mmHg) at screening visit blood pressure measurement.
- •Patients with secondary hypertension.
- •HbA1c>11%.
- •Patients are currently being hospitalized or planning to hospitalize due to hypertension.
- •Patients with severe renal disease (above 1.5 times the upper limit of normal serum creatinine levels).
- •Patients with any severe liver disease including cirrhosis (AST or ALT: above 3 times the upper limit of normal).
- •Patients who have been suffered cardiac infarction or severe coronary artery disease within 6 months, or with clinically significant congestive heart failure or heart valve defects.
- •Patients with phthisis, autoimmune disease or connective tissue disease.
- •Patients on medication therapies which may interfere with their blood pressure.
- •Patients with known history of allergic reaction or contraindication to angiotensin II antagonists.
- •Pregnant or lactating woman.
- •Patients with known history of alcoholism, mental illness, or drug dependency.
- •Patients who have participated in other study within 12 weeks prior to screening visit.
- •Any clinically significant medical condition including neurologic disease, gastrointestinal disease or malignant tumor, etc., which may affect the test results, or any other medical condition which in the opinion of the investigator makes the patients unsuitable for participation in the trial.
结局指标
主要结局
Clinic blood pressure
时间窗: 24 weeks
blood pressure value when hospital visiting * Clinic blood pressure * Changes in mean SBP(Systolic Blood Pressure) from baseline to 24 weeks visit
次要结局
- Clinic blood pressure-Diastolic Blood Pressure(DBP)(24 weeks)
- Percentage of subjects who achieved goal clinic blood pressure(24 weeks)
- 24 hours ABP(Ambulatory Blood Pressure)(24 weeks)
- Percentage of subjects who achieved 24 hours ABP(Ambulatory Blood Pressure) goal(24 weeks)
- Self blood pressure measurement(24 weeks)
- Medication compliance(24 weeks)
- Reduction of body mass index(24 weeks)
- Assessment of patients' satisfaction(24 weeks)
研究者
Chang Hee, Lee
Chief Research Engineer
LG Electronics Inc.
研究点 (3)
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