A Prospective Long-term Cohort Study to Identify the Predictive Model of Cardiocerebrovascular Risk Factors in Elderly Patients with More Than Three Antihypertensive Agents in Patients with Essential Hypertension in Korea

Yuhan Corporation5 sites in 1 country1,219 target enrollmentJune 8, 2022

ConditionsEssential Hypertension

DrugsTelmisartan/Amlodipine/Chlorthalidone(Truset)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Essential Hypertension
Sponsor: Yuhan Corporation
Enrollment: 1219
Locations: 5
Primary Endpoint: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination.

Detailed Description

This is a phase IV, open-label, prospective, long-term cohort, observational study to identify the predictive model of cardiocerebrovascular risk factors in elderly patients with more than three antihypertensive agents in patients with essential hypertension in Korea.

Registry

clinicaltrials.gov

Start Date

June 8, 2022

End Date

March 31, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Yuhan Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A patient over 65-year-old with essential hypertension
•A patient with essential hypertension who require treatment with 3 or more antihypertensive medication, as determined by investigator's decision
•A patient with no MACCE within 6 months prior to the enrollment
•A patient who voluntarily signed the informed consent form

Exclusion Criteria

•A patient who participates in clinical trial
•A patient who are contraindicated for the Truset tablet according to the label.
•A patient who is unable to complete the study judged by the investigator.

Outcomes

Primary Outcomes

Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)

Time Frame: 12, 24 and 36months

Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) after treatment at 12, 24 and 36months if applicable

Secondary Outcomes

Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage(12, 24 and 36months)
Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)(12, 24 and 36months)
Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)(36months)
Percentage of patients who terminated the treatment(36months)