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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
Republic of Korea
Seoul National University Bundang Hospital
RECRUITING
Seoul
Contact Information
Primary
MyungSook Hong
mshong@boryung.co.kr
+8227088238
Backup
JiYeon Kim
jiyeonkim@boryung.co.kr
+8227088128
Time Frame
Start Date: 2022-06-23
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20000
Authors
Chae InHo
Related Therapeutic Areas
Sponsors
Leads: Boryung Pharmaceutical Co., Ltd

This content was sourced from clinicaltrials.gov

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