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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06282549

Enrollment

1219

Registered

2024-02-28

Start date

2022-06-08

Completion date

2027-03-31

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Keywords

Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)

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.

Interventions

DRUGTelmisartan/Amlodipine/Chlorthalidone(Truset)

Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/25 mg

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026