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Hypertension and DyslipidemiaFIMASTARNCT04554953

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

An observational study of Hypertension and Dyslipidemia, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertension and Dyslipidemia
What is being tested?
Combination drug containing fimasartan and statins
How many people
10,877 participants
Where
1 siteSouth Korea
Study dates
13 Apr 2020to 31 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Participation in this study is possible only if all of the inclusion criteria below are satisfied.
  • 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
  • Adult males and females aged 19 years or above
  • 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
Show all 11Show fewer
  • 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 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)

Who cannot join

  • Patients cannot participate in this study if any of the following exclusion criteria is applicable.
  • Contraindication according to the drug labeling of the combination drug ingredients (fimasartan, amlodipine) for hypertension containing fimasartan
  • Contraindication according to the drug labeling of statins (rosuvastatin, atorvastatin)
  • Secondary hypertension or suspected secondary hypertension - Aortic coarctation, hyperaldosteronemia, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome, polycystic kidney disease, etc.
  • Secondary dyslipidemia or suspected secondary dyslipidemia
  • Nephrotic syndrome, dysproteinemia, obstructive liver disease, Cushing's syndrome, etc.
Show all 10Show fewer
  • Patients currently hospitalized or scheduled to be hospitalized
  • 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
  • Patients who are deemed ineligible for study participation at the discretion of the investigators for other reasons
  • -

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonnam National University Hospital

    Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, 42

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Combination drug containing fimasartan and statins
Keywords
Fimasartan and Statins
Medical subject headings
Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination drug containing fimasartan and statinsDrug

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week12

  2. 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

    Measured: Week 12

Secondary outcomes (6)

  1. 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.

    Measured: Week 12

  2. Average cost-effectiveness ratio (ACER)

    Average cost-effectiveness ratio (ACER) of the study drug at Week 12

    Measured: Week 12

  3. 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

    Measured: Week 12

  4. non-HDL-C controlled

    Proportion of patients with non-HDL-C controlled to the target level at Week 12

    Measured: Week 12

  5. Change in blood pressure

    Change in blood pressure at Week 12 from baseline

    Measured: Week 12

  6. 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

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start13 Apr 2020
  3. Primary completion3 Nov 2021
  4. Study completion31 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,877 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554953
Sponsor's protocol ID
BR-FMS-OS-406
Acronym
FIMASTAR
Status last verified
Dec 2024
First submitted
14 Sep 2020
Last updated
27 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Dyslipidemia, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure controlled to the target level (time frame: Week12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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