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

N/AActive Not RecruitingNCT06282549

Yuhan Corporation1,219 enrolled

Overview

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.

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

1,219

Conditions

Essential Hypertension

Interventions

Telmisartan/Amlodipine/Chlorthalidone(Truset)DRUG

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

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (5)

Busan Veterans Hospital

Busan, South Korea

Daegu Veterans Hospital

Daegu, South Korea

Gwangju Veterans Hospital

Gwangju, South Korea

Konkuk University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 12, 24 and 36months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 36months

Percentage of patients who terminated the treatment

To evaluate the percentage of patients who terminated the treatment before 36 months

Time frame: 36months

Data from ClinicalTrials.gov

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