Chonnam National University Hospital
Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, 42, South Korea
NCT Number: NCT04554953
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.
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All sexes
Observational
Gwangju, Jebong-ro, Jangseong-eup, Jangseong-gun, 42, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participation in this study is possible only if all of the inclusion criteria below are satisfied.
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Exclusion criteria
Patients cannot participate in this study if any of the following exclusion criteria is applicable.
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Patients who correspond to one of the following:
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.
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
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.
Time frame: Week 12
Average cost-effectiveness ratio (ACER) of the study drug at Week 12
Time frame: Week 12
Proportion of patients with both blood pressure and LDL-C controlled to the target level simultaneously at Week 12
Time frame: Week 12
Proportion of patients with non-HDL-C controlled to the target level at Week 12
Time frame: Week 12
Change in blood pressure at Week 12 from baseline
Time frame: Week 12
Lipid panel at Week 12 from baseline
Boryung Pharmaceutical Co., Ltd
Industry
A Multi-center, Prospective Observational Study to Evaluate the Effectiveness of a Combination Drug Including Fimasartan and Statins in Patients With Hypertension and Dyslipidemia
Acronym: FIMASTAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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