A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
试验速览
- 阶段
- 4 期
- 入组人数
- 208
- 试验地点
- 10
- 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
To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
详细描述
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 20 years in hypertension patient
- •Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening
- •Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg.
- •Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg.
- •Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
- •Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
- •Patient who decided to participate and signed on an informed consent form willingly
排除标准
- •Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg 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
- •Secondary Hypertension
- •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
- •type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c > 8.0%)
- •Severe or malignant retinopathy
- •Abnormal laboratory test results
- •Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 2
- •Serum creatinine > Upper normal limit X 2
- •Acute of chronic inflammatory status requiring treatment
- •Need for other antihypertensive drugs during the trial
- •Need for prohibited medication specified in the protocol
- •A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
- •Severe hypersensitivity to amlodipine or telmisartan
- •History of drug or alcohol abuse within 6 months
- •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
- •Administration of other Investigational Product within 30 days
- •Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- •History of malignant tumor within 5 years (including leukemia and lymphoma)
- •Another clinical condition in investigator's judgement
研究组 & 干预措施
night
Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
干预措施: Telminuvo®Tab. 40/2.5mg (Drug)
morning
Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
干预措施: Telminuvo®Tab. 40/2.5mg (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
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at 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 control at week 8.(Baseline and week 8)
- Morning BP Surge(Baseline and week 8)