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

NCT ID: NCT06041529

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-18

Study Completion Date

2025-10-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg

Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period

Group Type EXPERIMENTAL

Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg

Intervention Type DRUG

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

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period

Group Type ACTIVE_COMPARATOR

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

Intervention Type DRUG

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

Interventions

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Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg

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

Intervention Type DRUG

Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg

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

Intervention Type DRUG

Other Intervention Names

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Truset 40/5/12.5mg Twynsta 40/5 mg, Dichlozid 25 mg

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanghyun Ihm

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, Gyeonggi-do, South Korea

Site Status RECRUITING

Pusan National University Yangsan Hospital

Busan, , South Korea

Site Status RECRUITING

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

Daejeon, , South Korea

Site Status RECRUITING

Wonju Severance Christian Hospital

Gangwon-do, , South Korea

Site Status NOT_YET_RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Gwangju Veterans Hospital

Gwangju, , South Korea

Site Status RECRUITING

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

Gyeonggi-do, , South Korea

Site Status RECRUITING

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

Incheon, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Hanyang university medical center

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

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

Seoul, , South Korea

Site Status RECRUITING

Seoul national University Budang hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Minjun Kim

Role: CONTACT

+82-2-828-0508

bokyung Lee

Role: CONTACT

+82-2-828-0778

Facility Contacts

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Sanghyun lhm

Role: primary

Sanghyun Lee

Role: primary

Jungsun Cho

Role: primary

JangYoung Kim

Role: primary

Juhan Kim

Role: primary

Injae Kim

Role: primary

SungHo Her

Role: primary

Mijung Kim

Role: primary

Sukmin Seo

Role: primary

Jinho Shin

Role: primary

Eunho Choo

Role: primary

Eunjoo Cho

Role: primary

Jinoh Na

Role: primary

Hyosuk Ahn

Role: primary

Kwangil Kim

Role: primary

Other Identifiers

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YMC050

Identifier Type: -

Identifier Source: org_study_id

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