NCT04470817

A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea

Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil in the Treatment of Adult Patients With Essential Hypertension in South Korea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,438 (actual)
• Sponsor: Celltrion Pharm, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs already known, non-serious ADRs and other safety related information (laboratory values changes, etc).

Detailed description

This is a long-term prospective, observational post-marketing surveillance study of azilsartan medoxomil in participants with essential hypertension. This study will assess the safety and effectiveness of azilsartan medoxomil prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in real-world clinical practice settings. The study will enroll approximately 3000 participants. The data will be prospectively collected, at the centers from medical files and recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort: * Participants With Essential Hypertension The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits over the surveillance period, scheduled at Visit 1 (Baseline), Visit 2 (6 Weeks), Visit 3 (3 Months or more less than 6 Months) and Visit 4 (6 Months or more \[Month 9\]). The overall duration of the study will be approximately 6 years. All participants will be followed up for 9 months after drug administration.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Azilsartan Medoxomil	Azilsartan Medoxomil

Timeline

• Start date: 2018-08-07
• Primary completion: 2023-05-25
• Completion: 2023-05-25
• First posted: 2020-07-14
• Last updated: 2023-10-26

Locations

1 site across 1 country: South Korea