Observational study to investigate the effectiveness and safety of Sevikar HCT in Korean hypertensive patients with cardiovascular risk factor

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0003401
• Lead Sponsor: Hanyang University Seoul Hospital

Brief Summary

this observational study demonstrated the significant BP lowering effect of Sevikar HCT® Tab. in hypertension patients with cardiovascular risk factors in routine clinical practice. In addition, safety assessment results showed expected AEs with no particular findings of safety concern that are consistent with previous safety reports.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-01-27
• Last Update Posted: 2 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3145

Inclusion Criteria

1) Aged = 19 years
2) Naïve patients for Sevikar HCT® tablet and who are eligible for the treatment of Sevikar HCT® tablet according to the approved product label
3) Patients who are willing to be prescribed Sevikar HCT® tablet at physician's discretion
4) Hypertensive patients who have at least one of following CV risk factor
?- Age(men=45, women=55)
?- Smoking
?- Dyslipidemia
?- Diabetes mellitus
?- Chronic kidney disease
?- CVD history
5) Patients who give voluntary written informed consent to participate in the study

Exclusion Criteria

1) Patients who are simultaneously participating in the interventional studies could influence the processes and results of this study
2) Patients who were previously administered Sevikar HCT® tablet

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients achieving target BP (<130/80 mmHg) according to 2017 ACC/AHA guideline at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving target BP according to 2013 KSH guideline at 24 weeks;Percentage of patients achieving target BP by risk factor;BP responder* rate (reduction in SBP or DBP (>20/10 mm Hg) );Change in systolic/diastolic BP from baseline;Factors associated with achieving target BP