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NCT Number: NCT06041529

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

This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, South Korea

About this study

This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination) versus Telmisartan, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential hypertension uncontrolled by Telmisartan and Amlodipine Combinations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
Aged ≥ 65 with essential hypertension
Patient with uncontrolled essential hypertension at screening

If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg
If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg

Exclusion criteria

Patient who has history of drug allergic reactions
Known hypersensitivity to components of the investigational product
Patient who is unable to stop taking prohibited drugs
Test results showing the following values at screening

The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements
Pregnant or lactating women
Patient who is unable to maintain proper night sleep
Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
Administration of other investigational products within 3 months prior to screening.
An impossible one who participates in clinical trial by investigator's decision

Treatment and study plan

Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg

Drug

PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Other names: Truset 40/5/12.5mg

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Drug

PO, Once daily(QD), 8 weeks and 26 weeks if applicable

Other names: Twynsta 40/5 mg, Dichlozid 25 mg

Primary outcomes

Mean Systolic Blood Pressure (MSBP) in nighttime

Time frame: Week 8

To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8

Secondary outcomes

Mean Systolic Blood Pressure (MSBP) in nighttime

Time frame: Week 26 if applicable

To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable
Mean Diastolic Blood Pressure (MDBP) in nighttime

Time frame: Week 8 and Week 26 if applicable

To evaluate change from baseline in nighttime Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime

Time frame: Week 8 and Week 26 if applicable

To evaluate change from baseline in daytime Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)

Time frame: Week 8 and Week 26 if applicable

To evaluate change from baseline in 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable
Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)

Time frame: Week 8

To evaluate the percentage of patients who reached the treatment goal for nighttime Mean Systolic Blood Pressure (MSBP) (<110/65mmHg) measured by Ambulatory Blood Pressure Monitoring at Week 8
Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)

Time frame: Week 4, Week 8 and Week 26 if applicable

To evaluate change from baseline in Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP) measured by the Institution at Week 4, Week 8 and Week 26 if applicable
Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Week 4, Week 8 and Week 26 if applicable
- 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 Week 4, Week 8 and Week 26 if applicable
Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).

Time frame: Week 4, Week 8 and Week 26 if applicable

To evaluate the percentage of subjects with a Mean Sitting Systolic Blood Pressure (MSSBP) decrease of ≥20mmHg and a Mean Sitting Diastolic Blood Pressure (MSDBP) decrease of ≥10mmHg at Week 4, Week 8 and Week 26 if applicable
T/P ratio

Time frame: Week 8 and Week 26 if applicable

To evaluate the T/P ratio for systolic/diastolic blood pressure measured by Ambulatory Blood Pressure Monitoring at Week 8 and Week 26 if applicable

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients With Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Sep 18, 2023
Registry last updated: Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting