Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient(Kanarb-Hypertension Epidemiology Medication Satisfaction Study)

An observational study of Hypertension, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

1. Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients 2. Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypertension
How many people: 12,691 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Oct 2015
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 14,000 hypertensive patients anticipated 30% of hypertensive patients who does not satisfied their anti-hypertensive drugs

Who may be able to join

Step1
Over 20 years old
Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month
Step2
Patients does not taking Fimasartan
Patient's medication satisfaction score under 4

Who cannot join

Patients with secondary hypertension
Patients with orthostatic hypotension who has sign and symptom
Patients with known severe or malignancy retinopathy
Patients with significant investigations; abnormal renal function
Childbearing and breast-feeding women
Patients with history of allergic reaction to any angiotensin II antagonist

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Korea university Guro hospital
Seoul

Other trials in South Korea

About this study

Official title: Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient: a Prospective, Cross-sectional and Open-label 8 Week Switching Study

Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients
Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan

Conditions: Hypertension
Keywords: Medication satisfaction, Quality of life, Drug compliance
Medical subject headings: Hypertension, Medication Adherence

What is being measured

The primary outcome is the main question the study is designed to answer.

quality of life questionnaire for hypertension
Measured: up to 1 month
medication satisfaction questionnaire
Measured: up to 8 weeks

Secondary outcomes (1)

Drug compliance questionnaire
Measured: up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2015

First posted20 Mar 2015 (estimated)
Study startJul 2014
Primary completionAug 2015
Study completionOct 2015

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
Time perspective: Prospective
Enrolment: 12,691 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02394392
Sponsor's protocol ID: BR-FMS-OB-401
Acronym: K-HEMS
Status last verified: Jul 2016
First submitted: 10 Mar 2015
Last updated: 11 Jul 2016
Results posted: No
Data monitoring committee: No

Publications

Oh DJ, Han SE, Jeong SH, Hong MS, Choe SC. Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study). Clin Hypertens. 2018 Sep 1;24:10. doi: 10.1186/s40885-018-0096-2. eCollection 2018.
PubMed 30186623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Characteristics and Medication Satisfaction of Kanarb Tablet in Korean Hypertensive Patient: a Prospective, Cross-sectional and Open-label 8 Week Switching Study
ClinicalTrials.gov ID: NCT02394392
Acronym / sponsor ID: K-HEMS / BR-FMS-OB-401
Conditions: Hypertension
Keywords: Medication satisfaction, Quality of life, Drug compliance
Study type: Observational
Recruitment status: Completed
Enrolment: 12,691 participants (actual)
Lead sponsor: Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 20 Mar 2015 (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.

Investigate the clinical characteristics, medication satisfaction and quality of life of anti-hypertensive drugs in Korean hypertensive patients
Observe the changes of medication satisfaction and compliance in patients after switchting to Fimasartan

Study design

Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 14,000 hypertensive patients anticipated 30% of hypertensive patients who does not satisfied their anti-hypertensive drugs

Key inclusion criteria (6 listed)

Step1
Over 20 years old
Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month
Step2
Patients does not taking Fimasartan

Key exclusion criteria (6 listed)

Patients with secondary hypertension
Patients with orthostatic hypotension who has sign and symptom
Patients with known severe or malignancy retinopathy
Patients with significant investigations; abnormal renal function
Childbearing and breast-feeding women

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

quality of life questionnaire for hypertension
Time frame: up to 1 month
medication satisfaction questionnaire
Time frame: up to 8 weeks

1 secondary outcome

Drug compliance questionnaire
Time frame: up to 8 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 11 Jul 2016.
Derived from this study: PubMed 30186623Oh DJ, Han SE, Jeong SH, Hong MS, Choe SC. Clinical characteristics and satisfaction with the fimasartan in Korean hypertensive patients: a prospective, cross-sectional and open-label, 8-week switching study (Kanarb-hypertension epidemiology medication satisfaction study; K-HEMS study). Clin Hypertens. 2018 Sep 1;24:10. doi: 10.1186/s40885-018-0096-2. eCollection 2018.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 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 6 inclusion and 6 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 11 Jul 2016. 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?

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?

quality of life questionnaire for hypertension (time frame: up to 1 month). The study lists 2 primary outcomes in all. 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 NCT02394392, 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 11 Jul 2016.