NCT01983735Unknown3 期
A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
详细描述
- In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.
- This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years or older
- •at the screening visit
- •antihypertensive drugs not taking: 160mmHg ≤ sitSBP < 200mmHg
- •antihypertensive drugs taking: 140mmHg ≤ sitSBP < 180mmHg
- •at the randomization visit(160mmHg ≤ sitSBP < 200mmHg)
- •willing and able to provide written informed consent
排除标准
- •mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
- •for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
- •known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- •has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
- •has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- •Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%)
- •known severe or malignant retinopathy
- •defined by the following laboratory parameters:
- •hepatic dysfunction(AST/ALT > UNL X 3)
- •renal dysfunction(serum creatinine > UNL X 1.5)
- •hypopotassemia(K < 3.0mmol/L) or hyperpotassemia (K>5.5 mmol/L)
- •acute or chronic inflammatory status need to treatment
- •need to additional antihypertensive drugs during the study
- •need to concomitant medications known to affect blood pressure during the study
- •history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
- •known hypersensitivity related to either study drug
- •history of drug or alcohol dependency within 6 months
- •any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
- •administration of other study drugs within 4weeks prior to screening
- •premenopausal women(last menstruation > 1year) not using adequate contraception, pregnant or breast-feeding
- •history of malignancy including leukemia and lymphoma within the past 5 years
- •in investigator's judgment
研究组 & 干预措施
TELMINUVO Tab. (80/2.5mg, 80/5mg)
Experimental
干预措施: TELMINUVO Tab. (80/2.5mg) (Drug)
TELMINUVO Tab. (80/2.5mg, 80/5mg)
Experimental
干预措施: TELMINUVO Tab. (80/5mg) (Drug)
S-Amlodipine 2.5, 5mg
Active Comparator
干预措施: S-amlodipine 2.5mg (Drug)
S-Amlodipine 2.5, 5mg
Active Comparator
干预措施: S-amlodipine 5mg (Drug)
结局指标
主要结局
Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: After 8 weeks of treatment
次要结局
- Response Rate(After 8 weeks of treatment)
- Mean Sitting Diastolic Blood Pressure (MSDBP)(After 2weeks, 4weeks and 8 weeks of treatment)
- Mean Sitting Systolic Blood Pressure (MSSBP)(After 2 weeks and 4 weeks of treatment)
- Control Rate(After 8 weeks of treatment)
研究者
研究点 (1)
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