Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT06164379
Phase
PHASE4
Status
Unknown

Conditions

  • Primary Aldosteronism

Eligibility Criteria

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

Interventions

  • Finerenone — DRUG
    At every visit, the clinic and ambulatory blood pressure will be measured. The levels of serum potassium, creatinine, renin, aldosterone will be examined. The urinary microalbumin creatinine ratio will be also examined.
  • Spironolactone — DRUG
    At every visit, the clinic and ambulatory blood pressure will be measured. The levels of serum potassium, creatinine, renin, aldosterone will be examined. The urinary microalbumin creatinine ratio will be also examined.

Study Details

To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism

Key Dates

Start date
Dec 16, 2023
Status verified
Dec 2023
Primary completion
Dec 16, 2024
Completion
Dec 16, 2024

Study Design

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

Arms

  • Experimental: Finerenone group
    After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive finerenone 10mg once daily. Patients received the initial dose (10mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of finerenone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP \< 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone would be increased to 20mg once daily for the second 2 weeks later (week 2) and 30 mg 4 weeks later (week 4), respectively. The whole treatment period was 8 weeks. if blood pressure \> 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.
  • Active Comparator: Spironolactone group
    After the induction period of two weeks, the patients with primary aldosteronism were randomized in an equal ratio to receive spironolactone 20mg once daily. Patients received the initial dose (20mg, week 0) of drug for the first two weeks of randomized treatments period. Thereafter, the dose of spironolactone would not be changed for the adequate blood pressure (BP) control and the normal serum potassium. For patients not meeting BP \< 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finernone would be increased to 40mg once daily for the second 2 weeks later (week 2) and 60 mg 4 weeks later (week 4), respectively. the whole treatment period was 8 weeks. if blood pressure \> 160/110 mmHg during the clinical trial, amlodipine 5 mg once was added.

Primary Outcome Measure

The change of 24-hour ambulatory systolic blood pressure from the baseline level. [ Time Frame: 8 weeks ]

Central Contacts

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