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

NCT ID: NCT06282549

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-08

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Essential Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Telmisartan/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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changhoon Lee

Role: PRINCIPAL_INVESTIGATOR

Veterans Health Service Medical Center

Locations

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Busan Veterans Hospital

Busan, , South Korea

Site Status

Daegu Veterans Hospital

Daegu, , South Korea

Site Status

Gwangju Veterans Hospital

Gwangju, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Veterans Health Service Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YMC046

Identifier Type: -

Identifier Source: org_study_id

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