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

NCT ID: NCT04470817

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3438 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2023-05-25

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants With Essential Hypertension

Participants diagnosed with essential hypertension and whom have been prescribed azilsartan medoxomil as a monotherapy or taken concomitantly with other anti-hypertension therapies in a routine clinical practical setting, will be observed prospectively over a period of 6 years.

Azilsartan Medoxomil

Intervention Type: DRUG

Azilsartan Medoxomil

Interventions

Azilsartan Medoxomil

Azilsartan Medoxomil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. With Essential Hypertension.

• Newly diagnosed with essential hypertension or who have no long-term history of hypertension medication after diagnosis (The participant has a SBP or DBP >=140 or 90 mmHG, respectively).
• Receiving treatment with other hypertension medications.

2. Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.

Exclusion Criteria

1. Treated with azilsartan medoxomil outside of the locally approved label in South Korea.

2. With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.

3. Use of aliskiren in combination with azilsartan medoxomil in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate [GFR ] < 60 milliliter per minute [mL/min]/1.73 m^2).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion Pharm, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Celltrion Pharm, Inc.

Locations

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

U1111-1252-3589

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-491-4001

Identifier Type: -

Identifier Source: org_study_id