HypertensionAMPR-OS-2503NCT07784296
Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension
An observational study of Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
A multicenter, prospective, non-interventional, observational study to evaluate effectiveness and safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone) in Korean patients with hypertension Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- AMOPREL TAB 1.67/16.67/4.17mg
- How many people
- 3,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Mar 2026to 31 Aug 2028
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General hospital
Who may be able to join
- Korean patients aged 19 years or older diagnosed with hypertension
- Individuals newly diagnosed with hypertension or currently taking a single antihypertensive drug
- Individuals for whom administration of Amoprel tablets has been determined based on the researcher's medical judgment
- Individuals who have heard an explanation of this study and have voluntarily given written consent to participate in the study
Who cannot join
- Individuals falling under the contraindications listed in the precautions for use of Amoprel Tab. or Amozartan Plus Tab.
- Pregnant women, women who may be pregnant, and nursing mothers
- Individuals currently participating in an interventional study
- Individuals deemed unsuitable for participation in this study by the researcher for other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Gyeonggi-do, 16995
PM, +8224109291, juyoung.lee@hanmi.co.kr
About this study
Official title: A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension
A multicenter, prospective, non-interventional, observational study to evaluate effectiveness and safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone) in Korean patients with hypertension
- Conditions
- Hypertension
- Being tested
- AMOPREL TAB 1.67/16.67/4.17mg
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMOPREL TAB 1.67/16.67/4.17mgDrug
Follow-up of subjects prescribed medication in a non-intervention study
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Systolic Blood Pressure (SBP) relative to baseline
Measured: the 6-month time
Secondary outcomes (3)
effectiveness of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 2 and 4 months, and change from baseline in DBP at 6 months
Measured: 2, 4, 6 months
Prescription patterns of a triple-therapy-based stepwise treatment strategy
Proportion of Participants by Study Drug Dosage at Months 2, 4, and 6
Measured: 2, 4, 6 months
safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Incidence of Adverse Events During the 6-Month Follow-up Period
Measured: 2, 4 , 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start19 Mar 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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
- 3,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784296
- Sponsor's protocol ID
- HM-AMPR-OS-2503
- Acronym
- AMPR-OS-2503
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate Effectiveness and Safety of Sequential Triple Combination Therapy (Amlodipine/Losartan/Chlorthalidone) in Korean Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07784296
- Acronym / sponsor ID
- AMPR-OS-2503 / HM-AMPR-OS-2503
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
A multicenter, prospective, non-interventional, observational study to evaluate effectiveness and safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone) in Korean patients with hypertension
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General hospital
Key inclusion criteria (4 listed)
- Korean patients aged 19 years or older diagnosed with hypertension
- Individuals newly diagnosed with hypertension or currently taking a single antihypertensive drug
- Individuals for whom administration of Amoprel tablets has been determined based on the researcher's medical judgment
- Individuals who have heard an explanation of this study and have voluntarily given written consent to participate in the study
Key exclusion criteria (4 listed)
- Individuals falling under the contraindications listed in the precautions for use of Amoprel Tab. or Amozartan Plus Tab.
- Pregnant women, women who may be pregnant, and nursing mothers
- Individuals currently participating in an interventional study
- Individuals deemed unsuitable for participation in this study by the researcher for other reasons
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 |
|---|---|---|
| AMOPREL TAB 1.67/16.67/4.17mgFollow-up of subjects prescribed medication in a non-intervention study | Drug | – |
Primary outcome
The change in Systolic Blood Pressure (SBP) relative to baseline
Time frame: the 6-month time
3 secondary outcomes
effectiveness of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Time frame: 2, 4, 6 months
Prescription patterns of a triple-therapy-based stepwise treatment strategy
Time frame: 2, 4, 6 months
safety of sequential triple combination therapy (amlodipine/losartan/chlorthalidone)
Time frame: 2, 4 , 6 months
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 25 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Hanmi Pharmaceutical Company Limited at 1 site 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 4 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: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Systolic Blood Pressure (SBP) relative to baseline (time frame: the 6-month time). 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 25 Aug 2026.