NCT04470830

A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 718 (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 assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters including laboratory values, 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/chlorthalidone FDC in participants with essential hypertension. The study will assess the safety and effectiveness of azilsartan medoxomil/chlorthalidone FDC prescribed as a monotherapy or taken concomitantly with other anti-hypertension therapies in participants whose blood pressure is not properly controlled by azilsartan medoxomil monotherapy or who require administration of multiple drugs in order to reach the target blood pressure in routine clinical settings. The study will enroll and will consider approximately 600 participants. These participants will be grouped with the ones treated with azilsartan medoximil monotherpy. 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 (at least 3 months to 6 months) and Visit 4 (6 months or more up to 9 months) after drug administration. The overall duration of the study will be approximately 5 years. All participants will be followed up for 9 months after drug administration.

Conditions

• Essential Hypertension

Timeline

• Start date: 2019-09-11
• 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