Clinical Trial

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

Recruiting
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Record status
This record was last updated September 12, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-06-07; most recent amendment 2025-09-10.
Status change: Not Yet Recruiting → Recruiting 2022-07-07
Trial Details
NCT Number NCT05413057
Lead Sponsor Boryung Pharmaceutical Co., Ltd
Conditions Hypertension,Essential
Enrollment 20,000 participants
Start Date 2022-06-23
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-12