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

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ClinicalTrials.gov Identifier: NCT04554953
Recruitment Status : Recruiting
First Posted : September 18, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Study Description
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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.

Condition or disease Intervention/treatment
Hypertension and Dyslipidemia 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 Design
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Study Type : Observational
Estimated Enrollment : 10990 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: 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

Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure controlled to the target level [ Time Frame: Week12 ]
    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.

  2. LDL-C controlled to the target level [ Time Frame: Week 12 ]
    Proportion of patients with LDL-C controlled to the target level according to 'Guidelines for Management of Dyslipidemia 4th Edition1' at Week 12


Secondary Outcome Measures :
  1. Medication Satisfaction Questionnaire [ Time Frame: Week 12 ]
    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.

  2. Average cost-effectiveness ratio (ACER) [ Time Frame: Week 12 ]
    Average cost-effectiveness ratio (ACER) of the study drug at Week 12

  3. both blood pressure and LDL-C controlled [ Time Frame: Week 12 ]
    Proportion of patients with both blood pressure and LDL-C controlled to the target level simultaneously at Week 12

  4. non-HDL-C controlled [ Time Frame: Week 12 ]
    Proportion of patients with non-HDL-C controlled to the target level at Week 12

  5. Change in blood pressure [ Time Frame: Week 12 ]
    Change in blood pressure at Week 12 from baseline

  6. Change in Lipid panel [ Time Frame: Week 12 ]

    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554953


Contacts
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Contact: HyoJea Kim 02-708-8203 ext 010-2552-2711 igniter@boryung.co.kr

Locations
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Korea, Republic of
Chonnam National University Hospital Recruiting
Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, Korea, Republic of, 42
Contact: MyungHo Jung    82-10-2665-6243 ext 82-62-220-6243    mhjeong@chonnam.ac.kr   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
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Study Director: HyoJea Kim Boryung Pharmaceutical Co., Ltd
More Information
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Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT04554953    
Other Study ID Numbers: BR-FMS-OS-406
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boryung Pharmaceutical Co., Ltd:
Fimasartan and Statins
Additional relevant MeSH terms:
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Hypertension
Dyslipidemias
Vascular Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases