A Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia

NCT ID: NCT04554953

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10877 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-13
• Study Completion Date: 2022-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hypertension and Dyslipidemia

Keywords

Fimasartan and Statins

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Combination drug containing fimasartan and statins

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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:

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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

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

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• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonnam National University Hospital

Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, South Korea

Countries

South Korea

Other Identifiers

BR-FMS-OS-406

Identifier Type: -

Identifier Source: org_study_id