Evaluating the effectiveness and safety of fixed-dose combinations for treating essential hypertension

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

This study is testing if a new combination of blood pressure medications can help people with high blood pressure feel better and stay healthy over time.

Quick facts

• Study type: Observational
• Enrollment: 20000 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry-sponsored)
• Locations: 1 site (Seoul)
• Trial ID: NCT05413057 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect data on the effects and side effects of single-pill combinations of fimasartan/amlodipine or fimasartan/amlodipine/hydrochlorothiazide over a 12-week period. It will involve approximately 600 medical institutions and will follow participants for up to 2 years to assess long-term blood pressure control and major cardiovascular events. Participants will be enrolled based on their diagnosis of essential hypertension and will provide informed consent for data collection. The study will gather demographic information, vital signs, medication details, and any adverse reactions related to the treatments.

Who should consider this trial

Good fit: Ideal candidates include males and females over the age of 19 diagnosed with essential hypertension who consent to participate.

Not a fit: Patients with conditions other than essential hypertension or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of fixed-dose combinations for managing essential hypertension.

How similar studies have performed: Other studies have shown success with similar fixed-dose combination approaches in managing hypertension, indicating potential for positive outcomes.

Eligibility criteria

* Inclusion Criteria:

  1. Patients who voluntarily consent on the informed consent form and understand the study's purpose, methods, and so on
  2. Males and females over the age of 19
  3. 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
  4. 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:

  1. The patients who are suspected of having secondary hypertension or confirmed to have secondary hypertension
  2. The patients who are contraindicated to taking fimasartan complex according to the drug labelling
  3. 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.
  4. The patients who are not suitable for this study by the investigators

Where this trial is running

Seoul

• Seoul National University Bundang Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: MyungSook Hong

Conditions Hypertension,Essential; Fimasartan; Essentail hypertension