A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism
Status: Not_yet_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age: 18-75 years old.
• History of hypertension, Clinic DBP \<110 mmHg, SBP \<180 mmHg without any antihypertensive drugs for 2 weeks.
• Primary Aldosteronism diagnosed and confirmed by captopril inhibition test or Saline infusion test.
• At the end of induction, Serum potassium level ≥ 3 mmol/L but less than 5 mmol/L.
• Signed the informed consent
Locations
Other Locations
China
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Contact Information
Primary
Jiguang Wang, MD. PhD
jiguangw@163.com
+86-2164370045
Backup
Yuanyuan Kang, MD. PhD
kangyuanyuan@163.com
+86-2164370045
Time Frame
Start Date: 2023-12-16
Completion Date: 2024-12-16
Participants
Target number of participants: 150
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiao Tong University School of Medicine