NCT01258673已完成3 期
A Randomized, Double-blind, Multicenter Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Controlled by Fimasartan 60mg(Phase 3)
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
- 263
- 试验地点
- 1
- 主要终点
- Diastolic Blood Pressure
研究概览
简要总结
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan/Hydrochlorothiazide combination 60/12.5mg~120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.
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
- •Male and female outpatients 18 years of age and older
- •Patients with antihypertensive agents at screening: DBP<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg~120mmHg
- •Subjects who agree to participate in this sudy and give written informed consent
- •Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
- •Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg~109mmHg and SBP<180mmHg
排除标准
- •The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension
- •Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit
- •Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug
- •Patients with postural hypotension
- •Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening)
- •Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months
- •Patients with consumptive disease, autoimmune disease, connective tissue disease
- •Patients with a history of type B or C hepatitis(include carrier)
- •Patients with HIV or hepatitis
- •Patients with clinically significant laboratory abnormality
- •Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure
- •Patients with allergy or contraindication to any angiotensin II receptor antagonists
- •Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal
- •Patients judged to have a history of alcohol or drug abuse by the investigator
- •Patients participated other clinical trial 12 weeks before Screening - Patients judged to be inappropriate for this study by the investigator with other reasons
研究组 & 干预措施
Fimasartan/HCTZ combination group
Experimental
干预措施: Fimasartan/HCTZ combination (Drug)
Fimasartan group
Active Comparator
干预措施: Fimasartan (Drug)
结局指标
主要结局
Diastolic Blood Pressure
时间窗: 4week
次要结局
- Systolic Blood Pressure / Diastolic Blood Pressure(4week, 8week / 8week)
研究者
研究点 (1)
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