RecruitingNCT05413057

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

Sponsor

Boryung Pharmaceutical Co., Ltd

Enrollment

20,000 participants

Start Date

Jun 23, 2022

Study Type

OBSERVATIONAL

Conditions

Hypertension,Essential

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)

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking the real-world safety and effectiveness of a blood pressure medication regimen that combines fimasartan with amlodipine, with or without hydrochlorothiazide (HCTZ). These are drugs used to lower high blood pressure. **You may be eligible if...** - You are 19 or older - You have been diagnosed with essential hypertension (high blood pressure without a known secondary cause) - Your doctor has prescribed a combination of fimasartan/amlodipine (with or without HCTZ) - You have severe or high-risk hypertension, or your blood pressure is not adequately controlled on a single medication **You may NOT be eligible if...** - You are under 19 years old - You are being treated with different blood pressure medications not included in the study - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Seoul National University Bundang Hospital

Seoul, South Korea

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NCT05413057

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