Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension

Active, not recruiting

• Conditions: Essential Hypertension

• Registration Number: NCT06282549
• Lead Sponsor: Yuhan Corporation

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.

Study Timeline

• Study Start: 2022-06-08
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-19
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1219

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage	12, 24 and 36months	Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage after treatment at 12, 24 and 36months if applicable
Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)	12, 24 and 36months	To evaluate change from baseline in Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) measured by the Institution at 12, 24 and 36months if applicable
Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)	36months	To evaluate the percentage of patients who reached the treatment goal for Mean Sitting Blood Pressure (MSBP) \< 140/90 mmHg measured by the Institution at 12, 24 and 36months if applicable
Percentage of patients who terminated the treatment	36months	To evaluate the percentage of patients who terminated the treatment before 36 months

Trial Locations

Locations (5)

Busan Veterans Hospital; 🇰🇷 Busan, Korea, Republic of

Daegu Veterans Hospital; 🇰🇷 Daegu, Korea, Republic of

Gwangju Veterans Hospital; 🇰🇷 Gwangju, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Veterans Health Service Medical Center; 🇰🇷 Seoul, Korea, Republic of