NCT02022774已完成不适用
A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 7
- 主要终点
- Improvement of carotid radial strain value
研究概览
简要总结
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who agree to participate in this study and give written informed consent
- •Subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmHg and/or systolic blood pressure are more than 140 mmHg
- •Subjects who are naive to anti-hypertensive treatment
- •Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study
排除标准
- •Subjects who are hypersensitive to angiotensin type 1-receptor blockers
- •Subjects with secondary hypertension
- •Subjects with severe hypertension (systolic blood pressure >= 180 mmHg OR diastolic blood pressure >= 110)
- •Severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.)
- •Subjects with chronic obstructive pulmonary disease or history
- •Clinically significant renal dysfunction (Creatinine 2.0 mg/dL) and liver dysfunction (ALT, AST > 2x UNL)
- •Subjects with life expectancy of less than 2 years due to non-cardiac disease
- •Subjects with history or evidence of abuse of drugs or alcohol within 2 years
- •Severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use)
- •Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months)
- •Wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease.
- •Women with pregnancy and breast feeding
- •Women planning to be pregnant or without admitted contraception despite of probability of pregnancy (Women who underwent sterilization operation are excluded. Fertile women without such surgery should undergo pregnancy test and can participate only with negative result. Intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.).
- •Subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit.
- •Subjects judged to be inappropriate by the investigator
结局指标
主要结局
Improvement of carotid radial strain value
时间窗: 24 weeks
Improvement of carotid arterial stiffness measured by echocardiography
次要结局
- Improvement in brachial-ankle pulse wave velocity (baPWV)(24 weeks)
- Improvement in augmentation index (AIx)(24 weeks)
- Improvement in carotid distensibility(24 weeks)
- Improvement in sitting systolic blood pressure (SiSBP)(24 weeks)
- Improvement in sitting diastolic blood pressure (SiDBP)(24 weeks)
- Improvement in central blood pressure (BP)(24 weeks)
研究者
研究点 (7)
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