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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Apr 2024 to Jun 2026 Completion date: Oct 2026 to Jun 2026v4 Show 1 more changeShow less
    • Completion date: Oct 2026 to Jun 2026
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jun 2022 to Jun 23, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2022 to Jun 23, 2022
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT05413057
Lead Sponsor Boryung Pharmaceutical Co., Ltd
Conditions Hypertension,Essential
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov