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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Telmisartan/Amlodipine/Chlorthalidone(Truset)

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 Type: Observational
• Enrollment (Actual): 1219

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 46996
    • Busan Veterans Hospital
  • Daegu, Korea, Republic of, 42835
    • Daegu Veterans Hospital
  • Gwangju, Korea, Republic of, 62284
    • Gwangju Veterans Hospital
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05368
    • Veterans Health Service Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in General Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Changhoon Lee, Veterans Health Service Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Calcium Channel Blockers; Vasodilator Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Telmisartan; Amlodipine; Chlorthalidone; Telmisartan amlodipine combination
• Other Study ID Numbers: YMC046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No