This trial is active, not recruiting.

Condition hypertension
Treatment fimasartan
Sponsor Boryung Pharmaceutical Co., Ltd
Start date April 2012
End date December 2016
Trial size 90 participants
Trial identifier NCT02022774, CN-KKH-01


The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Improvement of carotid radial strain value
time frame: 24 weeks

Secondary Outcomes

Improvement in brachial-ankle pulse wave velocity (baPWV)
time frame: 24 weeks
Improvement in augmentation index (AIx)
time frame: 24 weeks
Improvement in carotid distensibility
time frame: 24 weeks
Improvement in sitting systolic blood pressure (SiSBP)
time frame: 24 weeks
Improvement in sitting diastolic blood pressure (SiDBP)
time frame: 24 weeks
Improvement in central blood pressure (BP)
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
Principal investigator Kye Hun Kim, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boryung Pharmaceutical Co., Ltd.