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.
Study Type
OBSERVATIONAL
Enrollment
12,000
Multiple centers in Republic of Korea
Seoul, South Korea
RECRUITINGChange 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).
Time frame: Baseline to 12 weeks (up to 20 weeks)
Change in clinic systolic and diastolic blood pressure
Change in clinic systolic and diastolic blood pressure from baseline.
Time frame: 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.
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
Change in variability indices of 24-hour, daytime, and nocturnal blood pressure.
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.