Finerenone for Patients With Primary Aldosteronism (FAIRY)

Sponsor
Qifu Li
Study ID
NCT06457074
Phase
PHASE4
Status
Recruiting
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Conditions

  • Primary Aldosteronism

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Finerenone Oral Tablet — DRUG
    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 — DRUG
    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).

Study Details

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

Key Dates

Start date
Jun 4, 2024
Status verified
Aug 2024
Primary completion
Jun 1, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Finerenone
    Patients divided into Finerenone group need to be treated with finerenone.
  • Active Comparator: Spironolactone
    Patients divided into Spironolactone group need to be treated with spironolactone.

Primary Outcome Measure

Change from baseline in 24-hour SBP [ Time Frame: 12 weeks ]

Central Contacts

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