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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension and Dyslipidemia
• Intervention / Treatment: Drug: Combination drug containing fimasartan and statins

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.

• Study Type: Observational
• Enrollment (Actual): 10877

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jebong-ro, Jangseong-eup, Jangseong-gun
    • Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, Korea, Republic of, 42
      • Chonnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

   -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
Average cost-effectiveness ratio (ACER)	Average cost-effectiveness ratio (ACER) of the study drug at Week 12	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	Week 12
non-HDL-C controlled	Proportion of patients with non-HDL-C controlled to the target level at Week 12	Week 12
Change in blood pressure	Change in blood pressure at Week 12 from baseline	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	Week 12

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Study Director: HyoJea Kim, Boryung Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2020
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Fimasartan and Statins
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias
• Other Study ID Numbers: BR-FMS-OS-406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No