Clinical trial

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

Name

YMC046

Description

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.

Trial arms

Trial start

2022-06-08

Estimated PCD

2027-03-31

Trial end

2027-03-31

Status

Recruiting

Treatment

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

Size

1210

Primary endpoint

Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)

12, 24 and 36months

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1210, 'type': 'ESTIMATED'}}

Updated at

2024-02-28

1 organization

1 product

1 indication

Product

Telmisartan/Amlodipine/Chlorthalidone(Truset)

Indication

Hypertension

Organization

Yuhan Corporation