Seoul National University Bundang Hospital
Seoul, South Korea
Location status: Recruiting
Location contact
InHo Chae, M.D., Ph.D.
CONTACT
InHo Chae, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05413057
The main purpose of this observation study is to collect data on the effects and side effects for 12 weeks of the medication administration of the single-pill combinations, which are fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide, based on fimasartan. (Stage 1).
Also, this study will evaluate major cardiovascular events, long-term blood pressure control, and the safety by follow-up of those who consent to the extended study for about 2 years (96 weeks).(Stage 2)
Interested in participating?
Request Info19 year and older
All sexes
Observational
Seoul, South Korea
Location status: Recruiting
InHo Chae, M.D., Ph.D.
CONTACT
InHo Chae, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
This study will be conducted as a prospective observational study in about 600 domestic medical institutions, which are at least clinical level.
The investigator will enroll those who have essential hypertension and meet the inclusion and exclusion criteria after obtaining voluntary written consent for participation in the study and use of personal information.
This study is a non-interventional observational study and is based on decisions by the investigator about the choice of antihypertensive drugs, the period of treatment, and the medication change status etc.
During this study period, the scope of data to be collected is as follows:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
If the patient is applicable, one of the following;
However, the following patients can participate in this study:
The patients who are currently enrolled in non-interventional clinical studies or who are being followed up on after the administration of investigational drugs has ended.
Time frame: Week 12
The blood pressure control rate (< 140/90 mmHg)(Systolic and Diastolic) at Week 12
Time frame: Week 8
The blood pressure control rate (< 140/90 mmHg) at Week 8
Time frame: Week 12
The target blood pressure control rate (< 140/90 mmHg) at Week 12
Time frame: Week 12
Change in central systolic pressure(CSP) and Central diastolic pressure(CDP) at Week 12 from baseline (Only the subjects who measured the central blood pressure)
Time frame: Week 36, Week 48, Week 96
Control rate of The Blood pressure control rate(< 140/90 mmHg) at Week 36 , 48 and 96
Time frame: Week 36, Week 48, Week 96
The target blood pressure control rate at Week 36 , 48 and 96
Time frame: Week 96
The incidence rate of major cardiovascular event(MACE)
Time frame: Week 12, Week 96
Adverse drug reactions(ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)
Time frame: Week 12, Week 96
Serious Adeverse Drug Reaction(Serious ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)
Contact information is provided by the study sponsor or research team.
JiYeon Kim
CONTACT
MyungSook Hong
CONTACT
Boryung Pharmaceutical Co., Ltd
Industry
A Multicenter, Prospective, Observational Study to Evaluate Effectiveness and Safety of Fixed-dose Combinations of Fimasartan/Amlodipine or Fimasartan/Amlodipine/Hydrochlorothiazide in Essential Hypertensive Patients
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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