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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorDaewoong Pharmaceutical Co. LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

12,000 Participants
are grouped into 1 trial group
Group A: Olmetec-Based Treatment Cohort

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline to 12 weeks (up to 20 weeks)

Secondary outcomes

1

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)
2

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)
3

Change in mean 24-hour diastolic blood pressure

Time frame
Baseline to 12 weeks (up to 20 weeks)
4

Change in nocturnal systolic and diastolic blood pressure

Time frame
Baseline to 12 weeks (up to 20 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.