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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06457074
Other study ID # FAIRY Study
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 4, 2024
Est. completion date June 1, 2026

Study information

Verified date May 2024
Source Chongqing Medical University
Contact Shumin Yang
Phone 02389011552
Email 443068494@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).


Description:

This is a multicenter, randomized study designed to evaluate efficacy and safety of finerenone in patients with PA. PA patients are randomly divided into two groups and treated with finerenone or spironolactone for 12 weeks. Spironolactone will be used as the control, while outcome will be assessed after 12-week treatment. Both drugs will be started at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Finerenone Oral Tablet
Eligible patients will be started finerenone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure <140/90 mmHg).
Spironolactone Oral Tablet
Eligible patients will be started spironolactone at 20mg per day, Dose will be adjusted every four weeks to achieve the targeted blood pressure (the mean office blood pressure <140/90 mmHg).

Locations

Country Name City State
China the first affiliated hospital of Chongqing medical university Chongqing Chongqing

Sponsors (5)

Lead Sponsor Collaborator
Qifu Li Changzhi Medical College, Second Affiliated Hospital, School of Medicine, Zhejiang University, The Affiliated Hospital Of Southwest Medical University, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (15)

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Outcome

Type Measure Description Time frame Safety issue
Other Proportion of subjects with AEs Adverse events(AEs) defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. 12 weeks
Other Proportion of subjects with SAEs and AEs leading to discontinuation of treatment with study drug Serious adverse events(SAEs) results in any of the following outcomes:Death;A life-threatening AE;Requires hospitalization or prolongation of existing hospitalizations;A persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions. 12 weeks
Other Change in eGFR from baseline. Blood was drawn to measure eGFR(mL/min/1.73m2) 12 weeks
Other Change from baseline in urinary albumin-to-creatinine ratio(UACR) Urine will be collected to measure UACR 12 weeks
Other Change from baseline in urinary Change in the UACR from baseline>30(mg/g Cr). Urine will be collected to measure UACR 12 weeks
Primary Change from baseline in 24-hour SBP Change from baseline in 24-hour systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Change from baseline in 24-hour DBP Change from baseline in 24-hour diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Change from baseline in daytime SBP Change from baseline in daytime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Change from baseline in daytime DBP Change from baseline in daytime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Change from baseline in nighttime SBP Change from baseline in nighttime systolic blood pressure (SBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Change from baseline in nighttime DBP Change from baseline in nighttime diastolic blood pressure (DBP) assessed by 24-hour ambulatory blood pressure monitoring compared to spironolactone after 12 weeks of finerenone therapy in patients with PA. 12 weeks
Secondary Blood pressure control rate at the end of the study Blood pressure control rate was defined as the number of patients with blood pressure controlled (with mean seated office BP<140/90mmHg at the end of the study)/ total number of patients in each group × 100%. 12 weeks
Secondary Serum potassium Change from baseline in Serum potassium, Blood was drawn to measure potassium. 12 weeks
Secondary Hypokalemia control rate at the end of the study Hypokalemia control rate was defined as the number of hypokalemic patients with serum potassium>3.5mmol/l at the end of the study/number of hypokalemic patients at baseline× 100%. 12 weeks
Secondary Plasma renin concentration Change from baseline in plasma renin concentration,Blood was drawn to measure renin. 12 weeks
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