ONgoing Evaluation of Depressor Effect And Safety of Combination Therapy With Telmisartan and Low-dose Hydrochlorothiazide in Patients With Hypertension Uncontrolled on Amlodipine Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in office blood pressure
研究概览
简要总结
The purpose of this study is to compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients.
详细描述
In hypertensive patients whose blood pressure (BP) does not reach less than 140/90 mmHg with 5mg/day of amlodipine are divided the following two groups and BP response, laboratory data, and adverse effects are compared. Group 1: 12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide. Group 2: Amlodipine is continuously administered.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 mg/day of amlodipine is administered for more than 3 months
- •Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
- •Outpatients
排除标准
- •Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
- •Administration of antihypertensives other than amlodipine
- •Cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
- •Serum creatinine >= 2.0 mg/dl
- •Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
- •Chronic heart failure (NYHA class>=III to VI)
- •Contraindication of telmisartan or hydrochlorothiazide
- •Hyper- (>= 5.5 mEq/L) or hypo- (<=3.5 mEq/l) potassemia
- •Untreated hyperuricemia or uncontrolled hyperuricemia (serum uric acid >= 8.0 mg/dl)
- •Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c >=9.0%), or patients who possess the risk of hypoglycemic attack
- •Patients inadequate for the study
研究组 & 干预措施
telmisartan plus low-dose hydrochlorothiazide
12 week combination therapy with telmisartan plus low-dose hydrochlorothiazide
干预措施: telmisartan plus hydrochlorothiazide (Drug)
Amlodipine
Amlodipine is continuously administered.
干预措施: Amlodipine (Device)
结局指标
主要结局
Changes in office blood pressure
时间窗: After 12 week treatment
次要结局
- 1) Home blood pressure in early morning and before going to bed 2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients(After 12 week treatment)
研究者
Hiroshi Satonaka
Professor
Tokyo University