Status:
COMPLETED
A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN 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 assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters inclu...
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 safet...
Eligibility Criteria
Inclusion
- Has a SBP or DBP \>=140 or 90 mmHg, respectively.
- Newly prescribed azilsartan medoxomil/chlorthalidone FDC as an early therapy for participants whose blood pressure is not properly controlled by monotherapy with azilsartan medoxomil or who require administration of multiple drugs in order to reach the target blood pressure in participants with stage 2 hypertension.
Exclusion
- With anuria.
- With refractory hypokalemia.
- With severe hepatic or renal impairment (estimate glomerular filtration rate \[eGFR\] \<30 milliliter per minute per 1.73 square meter \[mL/min/1.73 m\^2\]).
- With hyponatremia, hypercalcemia.
- With symptomatic hyperuricemia (history of gout and urate stone).
- With untreated Addison's disease.
- Receiving lithium therapy.
- Administrating terfenadine and/or astemizole.
- Use of aliskiren in combination with study drug in participants with diabetes or with moderate to severe renal impairment (glomerular filtration rate \[GFR\] \<60 mL/min/1.73m\^2).
- Participating in a clinical trial evaluating a hypertension treatment.
- Treated with azilsartan medoxomil / chlorthalidone FDC outside of the locally approved label in South Korea.
Key Trial Info
Start Date :
September 11 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2023
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT04470830
Start Date
September 11 2019
End Date
May 25 2023
Last Update
October 26 2023
Active Locations (1)
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1
Yeungnam University Medical Center
Daegu, Gyeongsangbuk-do, South Korea, 42415