HypertensionNCT06214832
An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine)
An observational study of Hypertension, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Nov 2021to 30 Aug 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Prescribed Lodient Tab for Hypertension Treatment
Who may be able to join
- Adults over 19 years of age
- A person diagnosed with hypertension
- A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab
- A person who voluntarily agreed in writing to this study
Who cannot join
- Pregnant women or nursing mothers
- Persons subject to prohibition according to the permission of the Lodient Tab
- Patients who in the judgement of the investigator, were inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul song clinic
Seoul
Minseop Song
About this study
Official title: An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine) and the Changes of Symptoms According to the Treatment Effect of Hypertension for Korean Hypertensive Patients
This study identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.
Read the detailed description
This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline
The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline
Measured: at 6 months of prescription for Lodient Tab compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start11 Nov 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Aug 2025 (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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Minseob Song, Study chair, Seoul song clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214832
- Sponsor's protocol ID
- HL-LDNT-401
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study on the Identification of Prescription Patterns of Lodient Tab(Telmisartan/S-amlodipine) and the Changes of Symptoms According to the Treatment Effect of Hypertension for Korean Hypertensive Patients
- ClinicalTrials.gov ID
- NCT06214832
- Acronym / sponsor ID
- HL-LDNT-401
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 22 Jan 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 identify prescription patterns of Lodient Tab and evaluate the changes of the hypertension symptoms (BP pressure) who are first prescribed and taking Lodient Tab.
Detailed description
This study aims to observe changes in symptoms according to the treatment effect of hypertension for 6 months after Lodient Tab prescription.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Prescribed Lodient Tab for Hypertension Treatment
Key inclusion criteria (4 listed)
- Adults over 19 years of age
- A person diagnosed with hypertension
- A person who has been first prescribed Lodient Tab within the past 4 months as of the IRB approval date or is scheduled to be prescribed Lodient Tab
- A person who voluntarily agreed in writing to this study
Key exclusion criteria (3 listed)
- Pregnant women or nursing mothers
- Persons subject to prohibition according to the permission of the Lodient Tab
- Patients who in the judgement of the investigator, were inappropriate to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline
Time frame: at 6 months of prescription for Lodient Tab compared to baseline
The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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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.
Minseob Song study chair
Seoul song clinic
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 Hanlim Pharm. Co., Ltd. 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 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: status not confirmed, as of the sponsor's last update on 22 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minseob Song (+820222737282, song2you@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who met target systolic blood pressure (less than 140mmHg) at 6 months of prescription for Lodient Tab compared to baseline (time frame: at 6 months of prescription for Lodient Tab compared to baseline). 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 22 Jan 2024.