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

Essential Hypertension Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282549
• Other study ID #: YMC046
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

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