Essential HypertensionPhase 4NCT06041529
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension
A Phase 4 study testing Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg and Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg in people with Essential Hypertension, run by Yuhan Corporation at 15 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg and Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 18 Oct 2023to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Pusan National University Yangsan Hospital
Busan, 50612
The Catholic University of Korea Daejeon ST. Mary's Hospital
Daejeon, 34943
Chonnam National University Hospital
Gwangju, 61469
Gwangju Veterans Hospital
Gwangju, 62284
The Catholic University of Korea, ST. Vincent's Hospital
Gyeonggi-do, 16247
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, 21431
The Catholic University of Korea Bucheon St.Mary's Hospital
Seoul, Gyeonggi-do, 14647
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
Hanyang university medical center
Seoul, 04763
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, 07345
Korea University Guro Hospital
Seoul, 08308
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Seoul, 11765
Seoul national University Budang hospital
Seoul, 13620
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
About this study
Official title: 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
Read the 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.
- Conditions
- Essential Hypertension
- Being tested
- Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg, Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
- Keywords
- Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mgDrug
Also called Truset 40/5/12.5mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mgDrug
Also called Twynsta 40/5 mg, Dichlozid 25 mg
PO, Once daily(QD), 8 weeks and 26 weeks if applicable
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 8
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 8 and Week 26 if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start18 Oct 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanghyun Ihm, Principal investigator, The Catholic University of Korea Bucheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041529
- Sponsor's protocol ID
- YMC050
- Status last verified
- Feb 2026
- First submitted
- 4 Sep 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06041529
- Acronym / sponsor ID
- YMC050
- Conditions
- Essential Hypertension
- Keywords
- Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg | Experimental | Drug: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mgTelmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period |
| Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg | Active comparator | Drug: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mgTelmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mgAlso: Truset 40/5/12.5mgPO, Once daily(QD), 8 weeks and 26 weeks if applicable | Drug | Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg |
| Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mgAlso: Twynsta 40/5 mg, Dichlozid 25 mgPO, Once daily(QD), 8 weeks and 26 weeks if applicable | Drug | Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg |
Primary outcome
Mean Systolic Blood Pressure (MSBP) in nighttime
Time frame: Week 8
To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8
9 secondary outcomes
Mean Systolic Blood Pressure (MSBP) in nighttime
Time frame: Week 26 if applicable
Mean Diastolic Blood Pressure (MDBP) in nighttime
Time frame: Week 8 and Week 26 if applicable
Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime
Time frame: Week 8 and Week 26 if applicable
24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)
Time frame: Week 8 and Week 26 if applicable
Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)
Time frame: Week 8
Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Week 4, Week 8 and Week 26 if applicable
Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: 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).
Time frame: Week 4, Week 8 and Week 26 if applicable
T/P ratio
Time frame: Week 8 and Week 26 if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanghyun Ihm principal investigator
The Catholic University of Korea Bucheon St.Mary's Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg and Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg in people with Essential Hypertension, run by Yuhan Corporation at 15 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic Blood Pressure (MSBP) in nighttime (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.