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NCT Number: NCT05413057

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

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)

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

InHo Chae, M.D., Ph.D.

CONTACT

InHo Chae, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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

Treatment and study plan

Primary outcomes

  1. The blood pressure control rate

    Time frame: Week 12

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

Secondary outcomes

  1. The blood pressure control rate

    Time frame: Week 8

    The blood pressure control rate (< 140/90 mmHg) at Week 8

  2. The target blood pressure control rate

    Time frame: Week 12

    The target blood pressure control rate (< 140/90 mmHg) at Week 12

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

    Time frame: Week 12

    Change in central systolic pressure(CSP) and Central diastolic pressure(CDP) at Week 12 from baseline (Only the subjects who measured the central blood pressure)

  4. Control rate of The Blood pressure control rate

    Time frame: Week 36, Week 48, Week 96

    Control rate of The Blood pressure control rate(< 140/90 mmHg) at Week 36 , 48 and 96

  5. The target blood pressure control rate

    Time frame: Week 36, Week 48, Week 96

    The target blood pressure control rate at Week 36 , 48 and 96

  6. The incidence rate of major cardiovascular event(MACE)

    Time frame: Week 96

    The incidence rate of major cardiovascular event(MACE)

Other outcomes

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

    Time frame: Week 12, Week 96

    Adverse drug reactions(ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)

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

    Time frame: Week 12, Week 96

    Serious Adeverse Drug Reaction(Serious ADR) related to fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide (From the baseline to Week 12, From the baseline to Week 96)

Study contacts

Contact information is provided by the study sponsor or research team.

JiYeon Kim

CONTACT

[email protected]

+8227088128

MyungSook Hong

CONTACT

[email protected]

+8227088238

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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