A Multi-center, Prospective Observational Study to Evaluate the Effectiveness of a Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia

BR-FMS-OS-406

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.

2020-04-13

2021-11-03

2022-05-31

Completed

10877

Inclusion Criteria: Participation in this study is possible only if all of the inclusion criteria below are satisfied. 1. Patients who provide written consent on the consent form for use of personal information after listening to explanations regarding the purpose, method, etc. of this study 2. Adult males and females aged 19 years or above 3. 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 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\*) * non-HDL-C (Total cholesterol - HDL-C (mg/dL)) \*LDL-C = Total cholesterol - HDL-C - (triglyceride/5) (mg/dL) Exclusion Criteria: Patients cannot participate in this study if any of the following exclusion criteria is applicable. 1. Contraindication according to the drug labeling of the combination drug ingredients (fimasartan, amlodipine) for hypertension containing fimasartan 2. Contraindication according to the drug labeling of statins (rosuvastatin, atorvastatin) 3. Secondary hypertension or suspected secondary hypertension - Aortic coarctation, hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome, polycystic kidney disease, etc. 4. Secondary dyslipidemia or suspected secondary dyslipidemia - Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, etc. 5. Patients currently hospitalized or scheduled to be hospitalized 6. If an investigational drug has been administered within 12 weeks of the enrollment date, or if participation in another clinical study during this study participation period is planned 7. Patients who are deemed ineligible for study participation at the discretion of the investigators for other reasons -

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 10877, 'type': 'ACTUAL'}}

2022-11-16