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

NCT06041529 | Active Not Recruiting Phase 4

• 1 other identifier: YMC050
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Essential Hypertension

Keywords

Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Mean Systolic Blood Pressure (MSBP) in nighttime

  Week 26 if applicable

• Mean Diastolic Blood Pressure (MDBP) in nighttime

  Week 8 and Week 26 if applicable

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

  Week 8 and Week 26 if applicable

• 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)

  Week 8 and Week 26 if applicable

• Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)

  Week 8

Study Arms (2)

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

EXPERIMENTAL

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

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

ACTIVE COMPARATOR

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

Interventions

Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg DRUG

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

Also known as: Truset 40/5/12.5mg

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg DRUG

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

Also known as: Twynsta 40/5 mg, Dichlozid 25 mg

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (15)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

The Catholic University of Korea Bucheon St.Mary's Hospital

Seoul, Gyeonggi-do, 14647, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

The Catholic University of Korea Daejeon ST. Mary's Hospital

Daejeon, 34943, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gwangju Veterans Hospital

Gwangju, 62284, South Korea

Location

The Catholic University of Korea, ST. Vincent's Hospital

Gyeonggi-do, 16247, South Korea

Location

The Catholic University of Korea, Incheon ST. Mary's Hospital

Incheon, 21431, South Korea

Location

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 03312, South Korea

Location

Hanyang university medical center

Seoul, 04763, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, 07345, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Seoul, 11765, South Korea

Location

Seoul national University Budang hospital

Seoul, 13620, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Telmisartan; Amlodipine; Chlorthalidone; Hydrochlorothiazide; telmisartan amlodipine combination

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; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzophenones; Phthalimides; Imides; Ketones; Sulfones; Sulfur Compounds; Isoindoles; Chlorothiazide; Benzothiadiazines; Thiazides

Study Officials

• Sanghyun Ihm

  The Catholic University of Korea Bucheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 18, 2023
• Study Start: October 18, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (15)