An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ
Recruiting · NCT05413057 · Observational (researchers observe without assigning treatment) · Lead sponsor: Boryung Pharmaceutical Co., Ltd
View the official record on ClinicalTrials.gov →What this trial is about
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)
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
- Males and females over the age of 19
- Patients who have been diagnosed with essential hypertension and plan to be treated with fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide
- If the patient is applicable, one of the following;
- If the patients have severe hypertension, stage 2 or higher(sit SBP ≥ 160 mmHg or sit DBP ≥ 100 mmHg), or high-risk hypertension (The cardiovascular risk score of the 2018 hypertension treatment guidelines by the Korean Society of Hypertension is applied.) The patients have never been treated with antihypertensive drugs for essential hypertension.
- If the patients are on concomitant administration of fimasartan/amlodipin and hydrochlorothiazide for essential hypertension or, If the patients are on concomitant administration of a fimasartan/hydrochlorothiazide combination and amlodipine for essential hypertension
- If the patients have a blood pressure of sitSBP ≥ 140 mmHg or sitDBP ≥ 90 mmHg even though they have been treated with antihypertensive drugs for essential hypertension
- The patients who understand this study and are available to participate in this study until the end of the study period with a cooperative attitude.
Exclusion criteria
- The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension
- The patients who are contraindicated to taking fimasartan complex according to the drug labelling
- The patients who are currently participation in another clinical trials (Drugs or medical devices) The patients who took an investigational drug within 12 weeks of the enrollment date
- 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.
- The patients who are not suitable for this study by the investigators
Where it is running
1 location listed.
- Seoul National University Bundang Hospital - Seoul, South Korea