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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 12 weeks (up to 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinic systolic and diastolic blood pressure | Change in clinic systolic and diastolic blood pressure from baseline. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yun Jeong Kong | Contact | 82-10-3206-5162 | yjkong246@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple centers in Republic of Korea | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| At 12 weeks (up to 20 weeks) |
| Change in mean 24-hour diastolic blood pressure | Baseline to 12 weeks (up to 20 weeks) |
| Change in nocturnal systolic and diastolic blood pressure | Baseline to 12 weeks (up to 20 weeks) |
| Change in daytime systolic and diastolic blood pressure | 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. | Baseline to 12 weeks (up to 20 weeks) |
| Change in dipping status (dipper/non-dipper proportion) | Baseline to 12 weeks (up to 20 weeks) |
| Dipper conversion rate | At 12 weeks (up to 20 weeks) |
| Change in morning blood pressure surge (MBPS) | Baseline to 12 weeks (up to 20 weeks) |
| Change in pulse pressure | Baseline to 12 weeks (up to 20 weeks) |