Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion
Completed
- Conditions
- Hypertension
- Registration Number
- NCT02022774
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of carotid radial strain value 24 weeks Improvement of carotid arterial stiffness measured by echocardiography
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (7)
Jeonju Jesus Hospital
🇰🇷Jeonju, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Gwagnju Christian Hospital
🇰🇷Gwangju, Korea, Republic of
Gwanju Veterans Hospital
🇰🇷Gwangju, Korea, Republic of
St. Carollo Hospital
🇰🇷Suncheon, Jeollanamdo, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of