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

Hypertension and Dyslipidemia Clinical Trial

— FIMASTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554953
• Other study ID #: BR-FMS-OS-406
• Status: Completed
• Start date: April 13, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10877
• Est. completion date: May 31, 2022
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 ? Triglyceride (TG) ? 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 -

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension
• Hypertension and Dyslipidemia

Intervention

Drug:
• Combination drug containing fimasartan and statins
Patients who correspond to one of the following: 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 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 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

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju	Jebong-ro, Jangseong-eup, Jangseong-gun

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Average cost-effectiveness ratio (ACER)	Average cost-effectiveness ratio (ACER) of the study drug at Week 12	Week 12
Secondary	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
Secondary	non-HDL-C controlled	Proportion of patients with non-HDL-C controlled to the target level at Week 12	Week 12
Secondary	Change in blood pressure	Change in blood pressure at Week 12 from baseline	Week 12
Secondary	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