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临床试验/NCT01028534
NCT01028534已完成不适用

Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea

Kyoto University, Graduate School of Medicine2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Blood pressure

研究概览

简要总结

The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.

详细描述

Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
  • Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

排除标准

  • Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months
  • Uncontrolled arrhythmia
  • Severe hepatic or renal disorders
  • Having poor prognosis disorders such as malignant disorders

研究组 & 干预措施

ARB plus increased ARB

Active Comparator

angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months

干预措施: Olmesartan and Azelnidipine (Drug)

ARB plus CCB

Active Comparator

angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months

干预措施: Olmesartan and Azelnidipine (Drug)

CCB plus ARB

Active Comparator

calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months

干预措施: Olmesartan and Azelnidipine (Drug)

结局指标

主要结局

Blood pressure

时间窗: Six months

次要结局

  • Health-related quality of life(Six months)
  • Oxygen desaturation index(Six months)
  • Pulse rate(Six months)
  • Endothelial dysfunction(Six months)
  • Sleep quality and sleepiness(Six months)

研究者

发起方
Kyoto University, Graduate School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Toru Oga

Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine

Kyoto University, Graduate School of Medicine

研究点 (2)

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