Comparison of efficacy in renoprotection between Azilsartan medoxomil and Enalapril : A randomized, open-labeled controlled trial

Phase 4

Completed

• Conditions: hypertension, antihypertensive therapy, Azilsartan medoxomil, Enalapril microalbuminuria, macroalbuminuria, renoprotective effect; Hypertension, albuminuria

• Registration Number: TCTR20220426002
• Lead Sponsor: Phramongkutklao Medicine Foundation

Brief Summary

A total of 50 patients with hypertension and albuminuria were recruited. At the end of treatment, systolic blood pressure level was significantly reduction in the azilsartan group compared with the enalapril group. In addition, at 24-week, significant reduction in median UACR of azilsartan group compared to the enalapril group was observed. There was no statistically significant difference between the two groups in hyperkalemia, estimated GFR, acute kidney injury and serious adverse events.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-05-01
• Study Start: 2022-04-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

hypertensive subjects age > 18 years old with albuminuria >30 mg/g Creatinine

Exclusion Criteria

1.pregnancy or planned pregnancy
2. hyperkalemia (K > 5 meq/L) after medication treatment
3.serum creatinine increase > 50% after ACEi/ARB use
4.hypotension
5.intolerable side effects of ACEi
6.anaphylaxis , angioedema

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urine albumin creatinine ratio 24 weeks mg/L, immunoturbid method

Secondary Outcome Measures

Name	Time	Method
change in eGFR, safety outcomes 24 weeks ml/min/1.73 m2 (CKD-EPI),