NCT05413057

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (estimated)
• Sponsor: Boryung Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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: * Demographic information * Disease information (historical diseases and concomitant diseases ) * Physical measurements and vital signs * Blood pressure Central Blood pressure and hemodynamic values (if applicable) * Information on antihypertensive drugs and other concomitant medications * Adverse drug reaction(ADR) and serious adverse drug reactions(SADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide * Information on cardiovascular events (Only if subjects are in long term follow-up) * Death information (Only if subjects are in long term follow-up)

Conditions

• Hypertension,Essential

Timeline

• Start date: 2022-06-23
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-06-09
• Last updated: 2025-09-12

Locations

1 site across 1 country: South Korea