Olmetec (with or without hydrochlorothiazide) for nighttime blood pressure control in stage 1 hypertension
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
Run by Daewoong Pharmaceutical Co. LTD. · NCT07515599 · Data updated 2026-11-12
This will try Olmetec or Olmetec Plus to see if they help control nighttime blood pressure in adults with stage 1 hypertension in Korea.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 12000 (estimated) |
| Sponsor | Daewoong Pharmaceutical Co. LTD. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 17, 2025 |
| Main results expected | July 31, 2026 |
| Study ends | January 31, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT07515599 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥19 years) in Korea with guideline-defined stage 1 hypertension who are newly prescribed Olmetec or Olmetec Plus and can undergo ABPM are ideal candidates.
✕Probably not a fit
Patients with secondary or severe hypertension, pregnant or breastfeeding individuals, those with severe renal or hepatic impairment, or people not starting Olmetec-based therapy are unlikely to benefit from this observational program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter observational registry of Korean adults with stage 1 hypertension who are newly prescribed Olmetec or Olmetec Plus during routine care. No additional interventions beyond standard medical care will be applied, and ambulatory blood pressure monitoring (ABPM) will be performed at baseline and after treatment to capture 24-hour, daytime, nocturnal blood pressures and variability. The primary endpoint is change in mean systolic blood pressure from baseline to 12 weeks (up to 20 weeks); secondary endpoints include diastolic pressure, nocturnal BP, BP variability, responder rates, and dipping pattern changes. Safety will be monitored through recording of adverse events to generate real-world evidence on effectiveness and tolerability of olmesartan-based therapy.
Why it matters
Potential benefit: If successful, Olmetec-based therapy might improve nighttime blood pressure control and reduce blood pressure variability, potentially lowering cardiovascular risk.
How similar studies have gone: Previous randomized and real-world studies of olmesartan and ARB/thiazide combinations have demonstrated reductions in 24-hour and nocturnal blood pressure, so this study applies those approaches in Korean routine practice.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Multiple centers in Republic of Korea
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Yun Jeong Kong
- Email: yjkong246@daewoong.co.kr
- Phone: 82-10-3206-5162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.