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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Essential Hypertension
• Intervention / Treatment: Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg; Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• South Korea
  • Busan, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Daejeon, South Korea, 34943
    • The Catholic University of Korea Daejeon St. Mary's Hospital
  • Gwangju, South Korea, 61469
    • Chonnam National University Hospital
  • Gwangju, South Korea, 62284
    • Gwangju Veterans Hospital
  • Gyeonggi-do, South Korea, 16247
    • The Catholic University of Korea, St. Vincent'S Hospital
  • Incheon, South Korea, 21431
    • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Seoul, South Korea, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 04763
    • Hanyang University Medical Center
  • Seoul, South Korea, 03312
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Seoul, South Korea, 07345
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Seoul, South Korea, 11765
    • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Seoul, South Korea, 13620
    • Seoul national University Budang hospital
  • Gangwon-do
    • Wŏnju, Gangwon-do, South Korea, 26426
      • Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Seoul, Gyeonggi-do, South Korea, 14647
      • The Catholic University of Korea Bucheon St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
2. Aged ≥ 65 with essential hypertension

3. 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:

1. Patient who has history of drug allergic reactions
2. Known hypersensitivity to components of the investigational product
3. Patient who is unable to stop taking prohibited drugs

4. 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
5. Pregnant or lactating women
6. Patient who is unable to maintain proper night sleep
7. Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
8. Administration of other investigational products within 3 months prior to screening.
9. An impossible one who participates in clinical trial by investigator's decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg; Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period	Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg; PO, Once daily(QD), 8 weeks and 26 weeks if applicable; Other Names: Truset 40/5/12.5mg
Active Comparator: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg; Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period	Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg; PO, Once daily(QD), 8 weeks and 26 weeks if applicable; Other Names: Twynsta 40/5 mg, Dichlozid 25 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Systolic Blood Pressure (MSBP) in nighttime	To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 26 if applicable	Week 26 if applicable
Mean Diastolic Blood Pressure (MDBP) in nighttime	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	Week 8 and Week 26 if applicable
Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime	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	Week 8 and Week 26 if applicable
24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)	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	Week 8 and Week 26 if applicable
Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)	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	Week 8
Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)	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	Week 4, Week 8 and Week 26 if applicable
Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)	- 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	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).	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	Week 4, Week 8 and Week 26 if applicable
T/P ratio	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	Week 8 and Week 26 if applicable

Collaborators and Investigators

• Sponsor: Yuhan Corporation
• Investigators: Principal Investigator: Sanghyun Ihm, The Catholic University of Korea Bucheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Phthalimides; Isoindoles; Benzenesulfonamides; Sulfonamides; Sulfones; Ketones; Benzophenones; Biphenyl Compounds; Chlorothiazide; Benzothiadiazines; Thiazides; Dihydropyridines; Imides; Telmisartan; Amlodipine; Hydrochlorothiazide; Chlorthalidone; telmisartan amlodipine combination
• Other Study ID Numbers: YMC050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No