HypertensionSTIFFNESSNCT02022774
Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion
An observational study of Hypertension, run by Boryung Pharmaceutical Co., Ltd at 7 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Fimasartan
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Apr 2012to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple secondary and tertiary centers
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Chonnam National University Hospital
Gwangju, 501-757
Gwagnju Christian Hospital
Gwangju
Gwanju Veterans Hospital
Gwangju
Wonkwang University Hospital
Iksan
Jeonbuk National University Hospital
Jeonju
Jeonju Jesus Hospital
Jeonju
St. Carollo Hospital
Suncheon, Jeollanamdo
About this study
Official title: A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension
- Conditions
- Hypertension
- Being tested
- Fimasartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FimasartanDrug
Also called BR-A-657-K
Fimasartan 60 ~ 120 mg/po take one tablet once a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of carotid radial strain value
Improvement of carotid arterial stiffness measured by echocardiography
Measured: 24 weeks
Secondary outcomes (6)
Improvement in brachial-ankle pulse wave velocity (baPWV)
Measured: 24 weeks
Improvement in augmentation index (AIx)
Measured: 24 weeks
Improvement in carotid distensibility
Measured: 24 weeks
Improvement in sitting systolic blood pressure (SiSBP)
Measured: 24 weeks
Improvement in sitting diastolic blood pressure (SiDBP)
Measured: 24 weeks
Improvement in central blood pressure (BP)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startApr 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kye Hun Kim, MD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022774
- Sponsor's protocol ID
- CN-KKH-01
- Acronym
- STIFFNESS
- Status last verified
- Jul 2023
- First submitted
- 3 Dec 2013
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT02022774
- Acronym / sponsor ID
- STIFFNESS / CN-KKH-01
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple secondary and tertiary centers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FimasartanAlso: BR-A-657-KFimasartan 60 ~ 120 mg/po take one tablet once a day | Drug | – |
Primary outcome
Improvement of carotid radial strain value
Time frame: 24 weeks
Improvement of carotid arterial stiffness measured by echocardiography
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kye Hun Kim, MD principal investigator
Chonnam National University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Boryung Pharmaceutical Co., Ltd at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of carotid radial strain value (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.