Observational Study to Evaluate the Efficacy of OLMETEC Tab on Nocturnal Blood Pressure Control in Patients With Stage Ⅰ Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stage 1 Hypertension. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Change in mean 24-hour systolic blood pressure [Time frame: Baseline to 12 weeks (up to 20 weeks)]
Secondary outcome measures (10)
- 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Multiple centers in Republic of Korea — Seoul
Identifiers
NCT: NCT07515599 · DW_OMT_DB_01