NCT02231788已完成4 期
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 11
- 主要终点
- Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
研究概览
简要总结
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
详细描述
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 19 years in hypertension patient
- •Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
- •Clinic MSSBP ≥ 140mmHg
- •Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease
- •Diabetes mellitus
- •Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR
- •Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL
- •Chronic kidney disease
- •Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2
- •Patient who decided to participate and signed on an informed consent form willingly
排除标准
- •Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg at the time of Screening and Randomization
- •As night workers who sleep during the day and whose working hours including 00:00 to 04:00
- •Abnormal laboratory test results
- •Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3
- •Serum creatinine > Upper normal limit X 4
- •Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
- •Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
- •Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
- •Patient who is planning for a renal transplantation during the trial
- •Severe or malignant retinopathy
- •Acute of chronic inflammatory status requiring treatment
- •A history of cancer within five years
- •A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
- •Severe hypersensitivity to amlodipine or telmisartan
- •Surgical or medical conditions
- •History of major gastrointestinal surgery
- •History of active inflammatory bowel syndrome within 12 months
- •Abnormal pancreatic functions
- •Gastrointestinal/rectal bleeding
- •Urinary tract obstruction
- •Need for other antihypertensive drugs during the trial
- •Need for prohibited medication specified in the protocol
- •Administration of other Investigational Product within 30 days
- •History of drug or alcohol abuse within 6 months
- •Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- •Another clinical condition in investigator's judgement
研究组 & 干预措施
Telminuvo®Tab. 40/2.5mg
Experimental
Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg
干预措施: Telminuvo®Tab. 40/2.5mg (Drug)
Telmitrend®Tab. 80mg
Active Comparator
Telmitrend®Tab.(Telmisartan) 80mg
干预措施: Telmitrend®Tab. 80mg (Drug)
结局指标
主要结局
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
时间窗: Baseline and week 8
次要结局
- Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8.(Baseline and week 8)
- Change from baseline in the clinic mean blood pressure at week 8.(Baseline and week 8)
- 24hr ABPM and Clinic BP response at week 8.(Baseline and week 8)
- 24hr ABPM and Clinic BP control at week 8.(Baseline and week 8)
研究者
研究点 (11)
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