New Triple-Drug combo aims to lower blood pressure better in seniors
NCT ID NCT06041529
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new fixed-dose combination pill containing three blood pressure medicines (telmisartan, amlodipine, and chlorthalidone) against another triple combination (with hydrochlorothiazide instead of chlorthalidone) in elderly patients whose blood pressure is not well controlled. About 198 participants aged 65 and older will take one of the two combinations for up to 26 weeks. The main goal is to see which pill better lowers nighttime blood pressure, with safety monitored throughout.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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198 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chonnam National University Hospital
Gwangju, 61469, South Korea
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Gwangju Veterans Hospital
Gwangju, 62284, South Korea
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Hanyang university medical center
Seoul, 04763, South Korea
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Korea University Guro Hospital
Seoul, 08308, South Korea
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Pusan National University Yangsan Hospital
Busan, 50612, South Korea
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Seoul national University Budang hospital
Seoul, 13620, South Korea
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The Catholic University of Korea Bucheon St.Mary's Hospital
Seoul, Gyeonggi-do, 14647, South Korea
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The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, 34943, South Korea
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The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
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The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, 21431, South Korea
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The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do, 16247, South Korea
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The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591, South Korea
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The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Seoul, 11765, South Korea
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The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, 07345, South Korea
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
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Other studies related to the condition(s) this trial covers.
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