Essential HypertensionNCT06282549
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients with Essential Hypertension
An observational study of Essential Hypertension, run by Yuhan Corporation at 5 sites in South Korea.
Trial summary
This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination. 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(Truset)
- How many people
- 1,219 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 8 Jun 2022to 31 Mar 2027
- Phase
- Observational
- 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
Study population: Patients in General Hospital
Who may be able to join
- A patient over 65-year-old with essential hypertension
- A patient with essential hypertension who require treatment with 3 or more antihypertensive medication, as determined by investigator's decision
- A patient with no MACCE within 6 months prior to the enrollment
- A patient who voluntarily signed the informed consent form
Who cannot join
- A patient who participates in clinical trial
- A patient who are contraindicated for the Truset tablet according to the label.
- A patient who is unable to complete the study judged by the investigator.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Busan Veterans Hospital
Busan, 46996
Daegu Veterans Hospital
Daegu, 42835
Gwangju Veterans Hospital
Gwangju, 62284
Konkuk University Medical Center
Seoul, 05030
Veterans Health Service Medical Center
Seoul, 05368
About this study
Official title: A Prospective Long-term Cohort Study to Identify the Predictive Model of Cardiocerebrovascular Risk Factors in Elderly Patients with More Than Three Antihypertensive Agents in Patients with Essential Hypertension in Korea
This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination.
Read the detailed description
This is a phase IV, open-label, prospective, long-term cohort, observational study to identify the predictive model of cardiocerebrovascular risk factors in elderly patients with more than three antihypertensive agents in patients with essential hypertension in Korea.
- Conditions
- Essential Hypertension
- Being tested
- Telmisartan/Amlodipine/Chlorthalidone(Truset)
- Keywords
- Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)
- 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(Truset)Drug
Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/25 mg
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) after treatment at 12, 24 and 36months if applicable
Measured: 12, 24 and 36months
Secondary outcomes (4)
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage after treatment at 12, 24 and 36months if applicable
Measured: 12, 24 and 36months
Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)
To evaluate change from baseline in Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP) measured by the Institution at 12, 24 and 36months if applicable
Measured: 12, 24 and 36months
Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)
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 12, 24 and 36months if applicable
Measured: 36months
Percentage of patients who terminated the treatment
To evaluate the percentage of patients who terminated the treatment before 36 months
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start8 Jun 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Changhoon Lee, Principal investigator, Veterans Health Service Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282549
- Sponsor's protocol ID
- YMC046
- Status last verified
- Nov 2024
- First submitted
- 20 Feb 2024
- Last updated
- 19 Nov 2024
- 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 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Long-term Cohort Study to Identify the Predictive Model of Cardiocerebrovascular Risk Factors in Elderly Patients with More Than Three Antihypertensive Agents in Patients with Essential Hypertension in Korea
- ClinicalTrials.gov ID
- NCT06282549
- Acronym / sponsor ID
- YMC046
- Conditions
- Essential Hypertension
- Keywords
- Telmisartan/Amlodipine/Chlorthalidone Fixed-Dose Combination (Truset)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,219 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Feb 2024 (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 develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination.
Detailed description
This is a phase IV, open-label, prospective, long-term cohort, observational study to identify the predictive model of cardiocerebrovascular risk factors in elderly patients with more than three antihypertensive agents in patients with essential hypertension in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients in General Hospital
Key inclusion criteria (4 listed)
- A patient over 65-year-old with essential hypertension
- A patient with essential hypertension who require treatment with 3 or more antihypertensive medication, as determined by investigator's decision
- A patient with no MACCE within 6 months prior to the enrollment
- A patient who voluntarily signed the informed consent form
Key exclusion criteria (3 listed)
- A patient who participates in clinical trial
- A patient who are contraindicated for the Truset tablet according to the label.
- A patient who is unable to complete the study judged by the investigator.
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(Truset)Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/12.5 mg or Telmisartan/Amlodipine/Chlorthalidone 80/5/25 mg | Drug | – |
Primary outcome
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events)
Time frame: 12, 24 and 36months
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) after treatment at 12, 24 and 36months if applicable
4 secondary outcomes
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage
Time frame: 12, 24 and 36months
Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP)
Time frame: 12, 24 and 36months
Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP)
Time frame: 36months
Percentage of patients who terminated the treatment
Time frame: 36months
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 19 Nov 2024.
- 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.
Changhoon Lee principal investigator
Veterans Health Service Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Hypertension, run by Yuhan Corporation at 5 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 4 inclusion and 3 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 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) (time frame: 12, 24 and 36months). 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 19 Nov 2024.