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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06282549
Other study ID # YMC046
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 8, 2022
Est. completion date March 31, 2027

Study information

Verified date February 2024
Source Yuhan Corporation
Contact Sungjae Lee
Phone +82-828-0366
Email sjlee@yuhan.co.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1210
Est. completion date March 31, 2027
Est. primary completion date March 31, 2027
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Korea, Republic of Busan Veterans Hospital Busan
Korea, Republic of Daegu Veterans Hospital Daegu
Korea, Republic of Gwangju Veterans Hospital Gwangju
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Veterans Health Service Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12, 24 and 36months
Secondary 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 12, 24 and 36months
Secondary 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 12, 24 and 36months
Secondary 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 36months
Secondary Percentage of patients who terminated the treatment To evaluate the percentage of patients who terminated the treatment before 36 months 36months
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