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

NCT06282549 | Active Not Recruiting

• 1 other identifier: YMC046
• Study Type: observational
• Target: 1,219
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Essential Hypertension

Keywords

Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  12, 24 and 36months

• Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)

  12, 24 and 36months

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

  36months

• Percentage of patients who terminated the treatment

  36months

Interventions

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in General Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (5)

Busan Veterans Hospital

Busan, 46996, South Korea

Location

Daegu Veterans Hospital

Daegu, 42835, South Korea

Location

Gwangju Veterans Hospital

Gwangju, 62284, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Veterans Health Service Medical Center

Seoul, 05368, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Changhoon Lee

  Veterans Health Service Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: June 8, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)