HypertensionFABULOUSNCT03231293
Fimasartan Blood Pressure Lowering After Acute Stroke
An observational study of Hypertension and Ischemic Stroke, run by Boryung Pharmaceutical Co., Ltd at 27 sites in South Korea.
Trial summary
This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Ischemic Stroke, Transient Ischemic Attack
- How many people
- 1,035 participants
- Where
- 27 sitesSouth Korea
- Study dates
- 28 Jul 2016to 5 Apr 2019
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients
Who may be able to join
- Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.
- Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure
- Suitable for administration of fimasartan
- The life expectancy should be over 6 months.
Who cannot join
- Patients already treated with antihypertensive medications
- Hemorrhagic stroke patients
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
South Korea27 sites
Korea University Ansan Hospital
Ansan
Hallym University Medical Center
Anyang
Dong-A University Hospital
Busan
Inje University Busan Paik Hospital
Busan
Pusan National University Hospital
Busan
Keimyung University Dongsan Medical Center
Daegu
Kyungpook National University Hospital
Daegu
Daejeon Eulji Medical Center
Daejeon
Inje University Ilsan Paik Hospital
Goyang
Myongji Hospital
Goyang
Chonnam National University Hospital
Gwangju
Chosun University Hospital
Gwangju
Inha University Hospital
Incheon
Jeju National University Hospital
Jeju City
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Ewha Womans University Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Inje University Sanggye Paik Hospital
Seoul
Kyunghee University Medical Center
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
Samsung Medical Center
Seoul
Seoul National University Boramae Medical Center
Seoul
Seoul St. Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Soonchunhyang University Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack
This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.
- Conditions
- Hypertension, Ischemic Stroke, Transient Ischemic Attack
- Medical subject headings
- Hypertension, Ischemic Stroke, Ischemic Attack, Transient
What is being measured
The primary outcome is the main question the study is designed to answer.
BP
Blood pressure control rate(<140/90 mmHg)
Measured: 24 weeks
Secondary outcomes (10)
BP
Blood pressure control rate(<140/90 mmHg)
Measured: 4, 12 weeks
BP
Blood pressure changes
Measured: 4, 12, 24 weeks
mRS
mRS changes
Measured: 4, 12, 24 weeks
Fimasartan-based treatment
Fimasartan-based treatment modalities
Measured: 24 weeks
Fimasartan starting point
Fimasartan starting point after stroke
Measured: 24 weeks
Stroke recurrence
Rate of stroke recurrence
Measured: 24 weeks
Cardiovascular events
Incidence of cardiovascular events
Measured: 24 weeks
Mortality rates from cardiovascular disease
Mortality rates from cardiovascular disease
Measured: 24 weeks
Mortality rates of any cause
Mortality rates of any cause
Measured: 24 weeks
Adverse events
Adverse events related to antihypertensive treatments
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 posted27 Jul 2017
- Study start28 Jul 2016
- Primary completion2 Nov 2018
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Sook Hong, Study director, Boryung Pharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231293
- Sponsor's protocol ID
- BR-FMS-OS-401
- Acronym
- FABULOUS
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2017
- Last updated
- 4 Nov 2019
- Results posted
- No
Publications
Hong KS, Kwon SU, Park JH, Cha JK, Jung JM, Kim YJ, Lee KB, Sohn SI, Lee YS, Rha JH, Kwon JH, Han SW, Kim BJ, Koo J, Choi JC, Sung SM, Lee SJ, Park MS, Ahn SH, Bang OY, Hwang YH, Nam HS, Park JM, Bae HJ, Kim EG, Lee KY, Oh MS. Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study. J Clin Neurol. 2021 Jul;17(3):344-353. doi: 10.3988/jcn.2021.17.3.344.
PubMed 34184441
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Longitudinal Observational Study to Assess the Effectiveness of Fimasartan-based Antihypertensive Treatment and Prognosis in Post-Acute Phase of Ischemic Stroke or Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT03231293
- Acronym / sponsor ID
- FABULOUS / BR-FMS-OS-401
- Conditions
- Hypertension, Ischemic Stroke, Transient Ischemic Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2016 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- 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.
This study evaluates the effectiveness of fimasartan-based antihypertensive treatment and prognosis in post-acute phase of ischemic stroke or transient ischemic attack patients. All participants will receive fimasartan, and the investigators will follow them up for 6 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1,032 subjects of post-acute phase of ischemic stroke or transient ischemic attack patients
Key inclusion criteria (4 listed)
- Ischemic stroke or transient ischemic attack occurs after 7 days to 3 months.
- Mean blood pressure measured 3 times at the first visit (Visit 1) should be over 140 mmHg for systolic blood pressure or 90 mmHg for diastolic blood pressure
- Suitable for administration of fimasartan
- The life expectancy should be over 6 months.
Key exclusion criteria (2 listed)
- Patients already treated with antihypertensive medications
- Hemorrhagic stroke patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BP
Time frame: 24 weeks
Blood pressure control rate(<140/90 mmHg)
10 secondary outcomes
BP
Time frame: 4, 12 weeks
BP
Time frame: 4, 12, 24 weeks
mRS
Time frame: 4, 12, 24 weeks
Fimasartan-based treatment
Time frame: 24 weeks
Fimasartan starting point
Time frame: 24 weeks
Stroke recurrence
Time frame: 24 weeks
Cardiovascular events
Time frame: 24 weeks
Mortality rates from cardiovascular disease
Time frame: 24 weeks
Mortality rates of any cause
Time frame: 24 weeks
Adverse events
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 4 Nov 2019.
- Derived from this study: PubMed 34184441Hong KS, Kwon SU, Park JH, Cha JK, Jung JM, Kim YJ, Lee KB, Sohn SI, Lee YS, Rha JH, Kwon JH, Han SW, Kim BJ, Koo J, Choi JC, Sung SM, Lee SJ, Park MS, Ahn SH, Bang OY, Hwang YH, Nam HS, Park JM, Bae HJ, Kim EG, Lee KY, Oh MS. Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study. J Clin Neurol. 2021 Jul;17(3):344-353. doi: 10.3988/jcn.2021.17.3.344.
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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.
Myung Sook Hong study director
Boryung Pharmaceutical Co., Ltd
27 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 and Ischemic Stroke, run by Boryung Pharmaceutical Co., Ltd at 27 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 2 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 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
BP (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231293, which also lists 1 linked publication.
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 4 Nov 2019.