Stage 1 HypertensionNCT07515599
Observational Study to Evaluate the Efficacy of OLMETEC Tab on Nocturnal Blood Pressure Control in Patients With Stage Ⅰ Hypertension
An observational study of Stage 1 Hypertension, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This is a prospective, multicenter, observational study to evaluate the effectiveness of Olmetec® or Olmetec Plus® on nocturnal blood pressure control in Korean patients with stage 1 hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stage 1 Hypertension
- How many people
- 12,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Sep 2025to 31 Jan 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage 1 hypertension in Korea who are newly prescribed Olmetec® or Olmetec Plus® according to routine clinical practice. Eligible patients are adults who meet the inclusion and exclusion criteria and are able to undergo ambulatory blood pressure monitoring (ABPM).
Who may be able to join
- Adults aged ≥19 years
- Patients diagnosed with stage 1 hypertension according to clinical guidelines
- Patients who are newly prescribed Olmetec® or Olmetec Plus® in routine -clinical practice
- Patients who are able to undergo ambulatory blood pressure monitoring (ABPM)
- Patients who voluntarily agree to participate and provide written informed consent
Who cannot join
- Patients with secondary hypertension
- Patients with severe hypertension requiring immediate pharmacological i-ntervention
- Patients with known hypersensitivity to olmesartan medoxomil, hydrochlorothiazide, or any component of the study drugs
- Patients who are pregnant, planning to become pregnant, or breastfeeding
- Patients with severe renal impairment or severe hepatic impairment
- Patients who are unable to comply with study procedures, including ABPM
- Patients who are deemed inappropriate for participation by the investigator
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
Multiple centers in Republic of Korea
Seoul
Yun Jeong Kong, 82-10-3206-5162, yjkong246@daewoong.co.kr
About this study
Official title: A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy of OLMETEC Tab. (or OLMETEC Plus Tab.) on Nocturnal Blood Pressure Control in Korean Patients With Stage Ⅰ Hypertension
This is a prospective, multicenter, observational study to evaluate the effectiveness of Olmetec® or Olmetec Plus® on nocturnal blood pressure control in Korean patients with stage 1 hypertension. Patients receiving Olmetec-based therapy in routine clinical practice will be followed to assess changes in ambulatory blood pressure, including nocturnal blood pressure and blood pressure variability.
Read the detailed description
This is a prospective, multicenter, observational study designed to evaluate the effectiveness of Olmetec® (olmesartan medoxomil) or Olmetec Plus® (olmesartan medoxomil/hydrochlorothiazide) on nocturnal blood pressure control in Korean patients with stage 1 hypertension.
In routine clinical practice, patients diagnosed with stage 1 hypertension and newly prescribed Olmetec® or Olmetec Plus® according to the approved label and the physician's clinical judgment will be enrolled and followed prospectively. No additional intervention beyond standard medical care will be applied.
Ambulatory blood pressure monitoring (ABPM) will be used to assess 24-hour blood pressure profiles, including nocturnal blood pressure, daytime blood pressure, and blood pressure variability. Measurements will be performed at baseline and after treatment to evaluate changes over time.
The primary objective of this study is to assess the change in mean systolic blood pressure from baseline to 12 weeks (up to 20 weeks). Secondary objectives include evaluation of diastolic blood pressure, nocturnal blood pressure, blood pressure variability, responder rate, and changes in dipping patterns. Safety will be assessed by monitoring adverse events during the study period.
This study aims to generate real-world evidence on the effectiveness and safety of Olmetec-based therapy in controlling nocturnal blood pressure and improving blood pressure variability in patients with stage 1 hypertension.
- Conditions
- Stage 1 Hypertension
- Keywords
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Olmetec-Based Treatment Cohort | Patients with stage 1 hypertension who are prescribed Olmetec® or Olmetec Plus® as part of routine clinical practice will be included. Patients will be followed prospectively to assess changes in nocturnal blood pressure and blood pressure variability using ambulatory blood pressure monitoring (ABPM). No intervention beyond standard clinical care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean 24-hour systolic blood pressure
Change in mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) from baseline to 12 weeks (up to 20 weeks).
Measured: Baseline to 12 weeks (up to 20 weeks)
Secondary outcomes (10)
Change in clinic systolic and diastolic blood pressure
Change in clinic systolic and diastolic blood pressure from baseline.
Measured: Baseline to 12 weeks (up to 20 weeks)
Responder rate
Proportion of patients achieving systolic blood pressure <140 mmHg or a reduction of ≥20 mmHg from baseline.
Measured: At 12 weeks (up to 20 weeks)
Change in mean 24-hour diastolic blood pressure
Measured: Baseline to 12 weeks (up to 20 weeks)
Change in nocturnal systolic and diastolic blood pressure
Measured: Baseline to 12 weeks (up to 20 weeks)
Change in daytime systolic and diastolic blood pressure
Measured: Baseline to 12 weeks (up to 20 weeks)
Change in blood pressure variability
Change in variability indices of 24-hour, daytime, and nocturnal blood pressure.
Measured: Baseline to 12 weeks (up to 20 weeks)
Change in dipping status (dipper/non-dipper proportion)
Measured: Baseline to 12 weeks (up to 20 weeks)
Dipper conversion rate
Measured: At 12 weeks (up to 20 weeks)
Change in morning blood pressure surge (MBPS)
Measured: Baseline to 12 weeks (up to 20 weeks)
Change in pulse pressure
Measured: Baseline to 12 weeks (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start17 Sep 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage 1 HypertensionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515599
- Sponsor's protocol ID
- DW_OMT_DB_01
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Observational Study to Evaluate the Efficacy of OLMETEC Tab. (or OLMETEC Plus Tab.) on Nocturnal Blood Pressure Control in Korean Patients With Stage Ⅰ Hypertension
- ClinicalTrials.gov ID
- NCT07515599
- Acronym / sponsor ID
- DW_OMT_DB_01
- Conditions
- Stage 1 Hypertension
- Keywords
- hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 Apr 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.
This is a prospective, multicenter, observational study to evaluate the effectiveness of Olmetec® or Olmetec Plus® on nocturnal blood pressure control in Korean patients with stage 1 hypertension. Patients receiving Olmetec-based therapy in routine clinical practice will be followed to assess changes in ambulatory blood pressure, including nocturnal blood pressure and blood pressure variability.
Detailed description
This is a prospective, multicenter, observational study designed to evaluate the effectiveness of Olmetec® (olmesartan medoxomil) or Olmetec Plus® (olmesartan medoxomil/hydrochlorothiazide) on nocturnal blood pressure control in Korean patients with stage 1 hypertension.
In routine clinical practice, patients diagnosed with stage 1 hypertension and newly prescribed Olmetec® or Olmetec Plus® according to the approved label and the physician's clinical judgment will be enrolled and followed prospectively. No additional intervention beyond standard medical care will be applied.
Ambulatory blood pressure monitoring (ABPM) will be used to assess 24-hour blood pressure profiles, including nocturnal blood pressure, daytime blood pressure, and blood pressure variability. Measurements will be performed at baseline and after treatment to evaluate changes over time.
The primary objective of this study is to assess the change in mean systolic blood pressure from baseline to 12 weeks (up to 20 weeks). Secondary objectives include evaluation of diastolic blood pressure, nocturnal blood pressure, blood pressure variability, responder rate, and changes in dipping patterns. Safety will be assessed by monitoring adverse events during the study period.
This study aims to generate real-world evidence on the effectiveness and safety of Olmetec-based therapy in controlling nocturnal blood pressure and improving blood pressure variability in patients with stage 1 hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olmetec-Based Treatment Cohort | – | –Patients with stage 1 hypertension who are prescribed Olmetec® or Olmetec Plus® as part of routine clinical practice will be included. Patients will be followed prospectively to assess changes in nocturnal blood pressure and blood pressure variability using ambulatory blood pressure monitoring (ABPM). No intervention beyond standard clinical care will be applied. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage 1 hypertension in Korea who are newly prescribed Olmetec® or Olmetec Plus® according to routine clinical practice. Eligible patients are adults who meet the inclusion and exclusion criteria and are able to undergo ambulatory blood pressure monitoring (ABPM).
Key inclusion criteria (5 listed)
- Adults aged ≥19 years
- Patients diagnosed with stage 1 hypertension according to clinical guidelines
- Patients who are newly prescribed Olmetec® or Olmetec Plus® in routine -clinical practice
- Patients who are able to undergo ambulatory blood pressure monitoring (ABPM)
- Patients who voluntarily agree to participate and provide written informed consent
Key exclusion criteria (7 listed)
- Patients with secondary hypertension
- Patients with severe hypertension requiring immediate pharmacological i-ntervention
- Patients with known hypersensitivity to olmesartan medoxomil, hydrochlorothiazide, or any component of the study drugs
- Patients who are pregnant, planning to become pregnant, or breastfeeding
- Patients with severe renal impairment or severe hepatic impairment
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
Change in mean 24-hour systolic blood pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) from baseline to 12 weeks (up to 20 weeks).
10 secondary outcomes
Change in clinic systolic and diastolic blood pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
Responder rate
Time frame: At 12 weeks (up to 20 weeks)
Change in mean 24-hour diastolic blood pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in nocturnal systolic and diastolic blood pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in daytime systolic and diastolic blood pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in blood pressure variability
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in dipping status (dipper/non-dipper proportion)
Time frame: Baseline to 12 weeks (up to 20 weeks)
Dipper conversion rate
Time frame: At 12 weeks (up to 20 weeks)
Change in morning blood pressure surge (MBPS)
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in pulse pressure
Time frame: Baseline to 12 weeks (up to 20 weeks)
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 7 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Stage 1 Hypertension, run by Daewoong Pharmaceutical 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 5 inclusion and 7 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 7 Apr 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?
Contact Yun Jeong Kong (82-10-3206-5162, yjkong246@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean 24-hour systolic blood pressure (time frame: Baseline to 12 weeks (up to 20 weeks)). 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 7 Apr 2026.