Clinical trial NCT04554953: A Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension and Dyslipidemia
Keywords: Fimasartan and Statins
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 10877
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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:

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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:

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

   -

Primary outcomes:
measure: Blood pressure controlled to the target level
timeFrame: Week12
measure: LDL-C controlled to the target level
timeFrame: Week 12
Secondary outcomes:
measure: Medication Satisfaction Questionnaire
timeFrame: Week 12
measure: Average cost-effectiveness ratio (ACER)
timeFrame: Week 12
measure: both blood pressure and LDL-C controlled
timeFrame: Week 12
measure: non-HDL-C controlled
timeFrame: Week 12
measure: Change in blood pressure
timeFrame: Week 12
measure: Change in Lipid panel
timeFrame: Week 12
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jebong-ro, Jangseong-eup, Jangseong-gun
Study officials:
References: