Status:
COMPLETED
A Study for PMS of AZL-M in the Treatment of Adult Participants With Essential Hypertension in South Korea
Lead Sponsor:
Celltrion Pharm, Inc.
Conditions:
Essential Hypertension
Eligibility:
All Genders
18+ years
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), unexpe...
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 effectivenes...
Eligibility Criteria
Inclusion
- 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.
- Newly prescribed and initiates azilsartan medoxomil for the treatment of hypertension, as a monotherapy or taken concomitantly with other anti-hypertension therapies.
Exclusion
- Treated with azilsartan medoxomil outside of the locally approved label in South Korea.
- With known hypersensitivity or presence of any contraindication to azilsartan medoxomil.
- 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).
Key Trial Info
Start Date :
August 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2023
Estimated Enrollment :
3438 Patients enrolled
Trial Details
Trial ID
NCT04470817
Start Date
August 7 2018
End Date
May 25 2023
Last Update
October 26 2023
Active Locations (1)
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1
Myongji Hospital
Goyang-si, Gyeonggi-do, South Korea, 10475