NCT01501253已完成3 期
Evaluate the Efficacy and Safety of a Fixed Dose Combination of S-Amlodipine and Telmisartan(CKD-828) vs. S-Amlodipine Monotherapy in Hypertensive Patients Inadequately Controlled by S-Amlodipine Monotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Mean Sitting Diastolic Blood Pressure (MSDBP)
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 S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg) in hypertensive patients inadequately controlled by S-Amlodipine monotherapy.
详细描述
- In patients with essential hypertension inadequately controlled by S-Amlodipine monotherapy to evaluate the efficacy and safety of two dose combination of S-Amlodipine/Telmisartan (2.5/40mg amd 2.5/80mg) compared with S-Amlodipine monotherapy (2.5mg)during 8weeks.
- Included S-Amlodipine run-in period(during 4 weeks_single blind) and Treatment period(during 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
- •diagnosis of essential hypertension and blood pressure not adequately controlled (inadequate control defined as seated diastolic blood pressure(DBP)≥ 90mmHg if on existing amtihypertensive treatment of seated DBP≥100mmHg if treatment naive)
- •failure to respond to four weeks treatment with S-Amlodipine 2.5mg(failure to respond defined as seated DBP ≥ 90mmHg)
- •willing and able to provide written informed consent
排除标准
- •mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 200mmHg during run-in treatment or mean seated DBP ≥ 120mmHg and/or mean seated SBP ≥ 180mmHg at the randomization visit
- •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), unstable angina or myocardial infarction, arrhythmia within the past three months
- •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
- •hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5
- •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 30 days prior to randomization
- •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
CKD-828 2.5/40mg
Experimental
CKD-828 2.5/40mg
干预措施: CKD-828 2.5/40mg (Drug)
CKD-828 2.5/80mg
Experimental
CKD-828 2.5/80mg
干预措施: CKD-828 2.5/80mg (Drug)
S-Amlodipine 2.5mg
Active Comparator
S-Amlodipine 2.5mg
干预措施: S-Amlodipine 2.5mg (Drug)
结局指标
主要结局
Mean Sitting Diastolic Blood Pressure (MSDBP)
时间窗: After 8 weeks of treatment
次要结局
- Mean Sitting Systolic Blood Pressure (MSSBP)(After 4 weeks and 8 weeks of treatment)
- Mean Sitting Diastolic Blood Pressure (MSDBP)(After 4 weeks of treatment)
- Response Rate(After 8 weeks of treatment)
- Control Rate(After 8 weeks of treatment)
研究者
研究点 (1)
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