Hypertension
Conditions
Brief summary
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension
Interventions
DRUGFimasartan
Fimasartan 60 \ 120 mg/po take one tablet once a day
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of carotid radial strain value | 24 weeks | Improvement of carotid arterial stiffness measured by echocardiography |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in augmentation index (AIx) | 24 weeks |
| Improvement in carotid distensibility | 24 weeks |
| Improvement in brachial-ankle pulse wave velocity (baPWV) | 24 weeks |
| Improvement in sitting diastolic blood pressure (SiDBP) | 24 weeks |
| Improvement in central blood pressure (BP) | 24 weeks |
| Improvement in sitting systolic blood pressure (SiSBP) | 24 weeks |
Countries
South Korea
Outcome results
None listed