Essential HypertensionNCT02385721
Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan)
An observational study of Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Essential Hypertension
- How many people
- 601 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Apr 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertension Patients
Who may be able to join
- Patients with essential hypertension
- Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
- Male and female adults aged 20 years or older
- Voluntarily provided a written consent to participate in the study
Who cannot join
- Patients with hypersensitivity to this drug or the ingredients of this drug
- Pregnant or breast-feeding women
- Patients on renal dialysis
- Patients with moderate to severe hepatic impairment
- Patients with biliary atresia
- Genetic disorders such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- Patients considered inappropriate for taking Kanarb tablet® (fimasartan) by investigator
- Clinically significant abnormal liver function (AST, ALT ≥2 x upper limit of normal (ULN); TB ≥1.5 ULN)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
Read the detailed description
This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Fimasartan
- Medical subject headings
- Essential Hypertension, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing AEs or ADRs
Number of participants experiencing AEs (or ADRs) during the study
Measured: up to 12 months
Secondary outcomes (1)
Treatment Persistence Rate of Fimasartan
Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMay 2013
- Primary completionJul 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 601 participants (actual)
- Target duration
- 12 Months
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
- NCT02385721
- Sponsor's protocol ID
- BR-FMS-PASS-401
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2015
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Oh GC, Joo KW, Kim MA, Choi DJ, Kim YJ, Lee HY. Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study. Drug Des Devel Ther. 2020 Apr 3;14:1341-1349. doi: 10.2147/DDDT.S233174. eCollection 2020.
PubMed 32308367
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Post-Authorization Long-term Safety Surveillance on Antihypertensive Treatment With Kanarb® (Fimasartan) During 1 Year Among 20 and Older Diagnosed With Essential Hypertension
- ClinicalTrials.gov ID
- NCT02385721
- Acronym / sponsor ID
- BR-FMS-PASS-401
- Conditions
- Essential Hypertension
- Keywords
- Hypertension, Fimasartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- May 2013 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluated the incidence and characteristics of adverse events during the treatment for Kanarb tablet.
Detailed description
This study is designed to evaluate the incidence and characteristics (profile, relationship to the study drug, severity, and outcome) of adverse events (AEs) observed during 1-year treatment with Kanarb tablet® (fimasartan)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertension Patients
Key inclusion criteria (4 listed)
- Patients with essential hypertension
- Taking Kanarb tablet® (fimasartan) as prescribed previously (within 1 month) or newly
- Male and female adults aged 20 years or older
- Voluntarily provided a written consent to participate in the study
Key exclusion criteria (8 listed)
- Patients with hypersensitivity to this drug or the ingredients of this drug
- Pregnant or breast-feeding women
- Patients on renal dialysis
- Patients with moderate to severe hepatic impairment
- Patients with biliary atresia
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
Number of Participants Experiencing AEs or ADRs
Time frame: up to 12 months
Number of participants experiencing AEs (or ADRs) during the study
1 secondary outcome
Treatment Persistence Rate of Fimasartan
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32308367Oh GC, Joo KW, Kim MA, Choi DJ, Kim YJ, Lee HY. Long-Term Safety of a Novel Angiotensin Receptor Blocker, Fimasartan, According to the Absence or Presence of Underlying Liver Disease in Korean Hypertensive Patients: A Prospective, 12-Month, Observational Study. Drug Des Devel Ther. 2020 Apr 3;14:1341-1349. doi: 10.2147/DDDT.S233174. eCollection 2020.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site 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 8 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 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 1 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Experiencing AEs or ADRs (time frame: up to 12 months). 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 NCT02385721, 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 6 Mar 2019.