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NCT Number: NCT06282549

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Busan Veterans Hospital, Busan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage

    Time frame: 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

  2. Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)

    Time frame: 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

  3. Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)

    Time frame: 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

  4. Percentage of patients who terminated the treatment

    Time frame: 36months

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

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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