Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05413057

An OS to Evaluate Effectiveness and Safety of Fixed-dose Combinations of FMS/AML or FMS/AML/HCTZ

Sponsor: Boryung Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

Summary

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)

Official title: 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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20000

Start Date

2022-06-23

Completion Date

2026-06

Last Updated

2025-09-12

Healthy Volunteers

Conditions

Hypertension,Essential

* Inclusion Criteria: 1. Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on 2. Males and females over the age of 19 3. 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 4. 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: 1. The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension 2. The patients who are contraindicated to taking fimasartan complex according to the drug labelling 3. 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. 4. The patients who are not suitable for this study by the investigators

Locations (1)

Seoul National University Bundang Hospital

Seoul, South Korea