Observational Study to Evaluate the Efficacy of OLMETEC Tab on Nocturnal Blood Pressure Control in Patients With Stage Ⅰ Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Stage 1 Hypertension

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 Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Yun Jeong Kong; Phone Number: 82-10-3206-5162; Email: yjkong246@daewoong.co.kr

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Multiple centers in Republic of Korea
    • Contact: Yun Jeong Kong; Phone Number: 82-10-3206-5162; Email: yjkong246@daewoong.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: DW_OMT_DB_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No