An observational study in Hypertension and Dyslipidemia, sponsored by Boryung Pharmaceutical Co., Ltd. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Boryung Pharmaceutical Co., Ltd · Observational
The primary objective of this study is to evaluate the effectiveness of a combination drug containing fimasartan and statins on the control of hypertension and dyslipidemia, and the secondary objective is to evaluate the drug cost reduction effect, patients' satisfaction level and safety of the combination drug administration.
This study is designed as a non-interventional, multicenter, prospective observational study for patients with hypertension and dyslipidemia. If a patient voluntarily provides written consent to provide information for this study, the enrollment number will be assigned to subjects who meet the inclusion/exclusion criteria, and follow-up will be conducted for approximately 12 weeks. Pre-specified study-related data will be collected in the case report form during the observation period.
This is an observational study, and the number or interval of subjects' visits to the hospital is determined by the investigators' clinical judgment under actual medical circumstances in principle. Whether to participate in this study will not affect the patients' treatment (physician's prescription or diagnostic, therapeutic decisions).
The follow-up time points specified below indicate the time points of data collection. That is, the schedule of subjects' visits is freely determined by the investigators based on the medical condition of the subjects regardless of the follow-up time points specified in this protocol, but data that are generated during the study period and are deemed necessary in relation to the study may be collected in the case report form.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 10,877 is above the median of 210 across 1,392 observational studies indexed under Hypertension.
Browse Hypertension studies →Boryung Pharmaceutical Co., Ltd is the lead sponsor of 143 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
10,990 subjects This study involves patients with hypertension and dyslipidemia, and its purpose is to investigate the control rate of hypertension and dyslipidemia, drug cost reduction effect, patients' satisfaction level, and rare adverse events of combination drugs containing fimasartan and statins.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participation in this study is possible only if all of the inclusion criteria below are satisfied.
<!-- -->
Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin 4. The following test results available within 4 weeks prior to the enrollment date
Total Cholesterol (TC)
HDL-C ③ Triglyceride (TG) ④ LDL-C or LDL-C (Friedewald formula*)
Exclusion Criteria:
Patients cannot participate in this study if any of the following exclusion criteria is applicable.
Secondary dyslipidemia or suspected secondary dyslipidemia
- Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, etc.
Patients who are deemed ineligible for study participation at the discretion of the investigators for other reasons
-
Patients who correspond to one of the following: 1. Patients who are planning to be treated with a combination drug containing fimasartan and statins after being newly diagnosed with essential hypertension and primary hypercholesterolemia 2. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension or primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB or dyslipidemia treatment that is containing a statin 3. Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin
Blood pressure controlled to the target level
Proportion of patients with blood pressure controlled to the target level (SiSBP, SiDBP) according to '2018 Guidelines for Management of Hypertension2' at Week 12. Site staff will be measuring Systolic and Diastolic Blood Pressure.
Time frame: Week12
LDL-C controlled to the target level
Proportion of patients with LDL-C controlled to the target level according to 'Guidelines for Management of Dyslipidemia 4th Edition1' at Week 12
Time frame: Week 12
Medication Satisfaction Questionnaire
Score (or change in the scores) of Medication Satisfaction Questionnaire (MSQ) assessed by patients at Week 12/ The scale title is MSQ(Medication satisfaction Questionnaire). The minimum score is '1' and maximum score is '7'. Higher score means a better outcome.
Time frame: Week 12
Average cost-effectiveness ratio (ACER)
Average cost-effectiveness ratio (ACER) of the study drug at Week 12
Time frame: Week 12
both blood pressure and LDL-C controlled
Proportion of patients with both blood pressure and LDL-C controlled to the target level simultaneously at Week 12
Time frame: Week 12
non-HDL-C controlled
Proportion of patients with non-HDL-C controlled to the target level at Week 12
Time frame: Week 12
Change in blood pressure
Change in blood pressure at Week 12 from baseline
Time frame: Week 12
Change in Lipid panel
Lipid panel at Week 12 from baseline * Percent change in TC * Percent change in HDL-C * Percent change in TG * Percent change in LDL-C * Percent change in non-HDL-C
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boryung Pharmaceutical Co., Ltd →