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
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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RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2023-10-18
2025-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
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
Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg
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
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
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
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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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
Pusan National University Yangsan Hospital
Busan, , South Korea
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, , South Korea
Wonju Severance Christian Hospital
Gangwon-do, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Gwangju Veterans Hospital
Gwangju, , South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do, , South Korea
he Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, , South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, , South Korea
Hanyang university medical center
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Seoul, , South Korea
Seoul national University Budang hospital
Seoul, , South Korea
Countries
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Central Contacts
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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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