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

NCT05413057 | Recruiting

• 1 other identifier: BR-FMS-OS-408
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Hypertension,Essential

Keywords

Fimasartan; Essentail hypertension

Outcome Measures

Primary Outcomes (1)

• The blood pressure control rate

  The blood pressure control rate (\< 140/90 mmHg)(Systolic and Diastolic) at Week 12

  Week 12

Secondary Outcomes (6)

• The blood pressure control rate

  Week 8

• The target blood pressure control rate

  Week 12

• Change in central systolic pressure(CSP) and Central diastolic pressure(CDP)

  Week 12

• Control rate of The Blood pressure control rate

  Week 36, Week 48, Week 96

• The target blood pressure control rate

  Week 36, Week 48, Week 96

Other Outcomes (2)

• Adverse drug reactions(ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide

  Week 12, Week 96

• Serious Adeverse Drug Reaction(Serious ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide

  Week 12, Week 96

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Essential hypertensive patients in need of a combination treatment with two or more antihypertensive agents

You may qualify if:

• Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
• Males and females over the age of 19
• 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
• 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.

You may not qualify if:

• The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension
• The patients who are contraindicated to taking fimasartan complex according to the drug labelling
• 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.
• The patients who are not suitable for this study by the investigators

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• MyungSook Hong

  Boryung Co.,Ltd.

  STUDY DIRECTOR

Central Study Contacts

MyungSook Hong

CONTACT

+8227088238; mshong@boryung.co.kr

JiYeon Kim

CONTACT

+8227088128; jiyeonkim@boryung.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: June 23, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)