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

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Jun 7, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of two different combinations of medications to treat high blood pressure, also known as hypertension. The medications being studied are fimasartan combined with amlodipine, and fimasartan combined with amlodipine and hydrochlorothiazide. The trial will first observe the effects and any side effects of these medications over a 12-week period. After that, for those who choose to continue, the study will follow participants for up to two years to see how well the medications control blood pressure over the long term and to check for major heart-related events.

To participate in this study, individuals must be at least 19 years old and have been diagnosed with essential hypertension, which is a common type of high blood pressure. Participants should not have any other conditions that cause high blood pressure, and they should be willing to commit to the study for its duration. Throughout the trial, participants will be monitored closely, and their experiences will help researchers understand how these medications work in real-life situations. If you or someone you know is interested in participating, it’s important to discuss this with a healthcare provider to see if eligibility requirements are met.

Gender

ALL

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