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NCT06381323CompletedPhase 4

The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism

Study on the Clinical Efficacy and Safety of the New Mineralocorticoid Receptor Antagonist Finerenone in the Treatment of Primary Aldosteronism: a Multicenter, Prospective, Open-label Clinical Study

Source: ClinicalTrials.gov · Last updated 10 Sept 2025

Brief summary (registry, in English)

The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
55 (actual)
First submitted
16 Apr 2024
Start date
1 Mar 2024
Primary completion date
1 Jun 2025
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT number
NCT06381323

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 55
  • From 1 Mar 2024 to the primary completion date, 1 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of spironolactone, hydralazine, or minoxidil within 30 days prior to enrollment.
  • Concurrent use of potent CYP3A4 inhibitors or inducers for treatment.
  • Pregnancy or planning pregnancy within 3 months before or after treatment, and breastfeeding women.

Other illness

  • Other secondary hypertension (such as renal vascular hypertension, Cushing's syndrome, subclinical Cushing's syndrome, and pheochromocytoma) or hypertensive crisis.
  • Heart failure, acute myocardial infarction, stroke, transient ischemic attack, or other acute cardiovascular events within the past 6 months.
  • History of adrenal surgery within the past 6 months.
  • History of carotid artery surgery within the past 6 months.
  • History of arterial vascular reconstruction surgery within the past 6 months.
  • Known or suspected tumors; other autoimmune diseases, uncontrolled infectious diseases, severe respiratory, blood, and neurological diseases.
  • Mental illness, alcohol or drug abuse, inability to cooperate with treatment.

Lab values

  • Hospitalization within the past year due to severe hyperkalemia, with serum potassium levels \<2.5 or ≥5.0 mmol/L.
  • Abnormal liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5× upper limit of normal (ULN), total bilirubin (TBIL) \> 1.5× ULN.

Other

  • Orthostatic hypotension.
  • Patients with pacemakers.
  • Participation in other clinical trials.

Who the study is looking for

  • Age:18-75 years old.
  • History of hypertension, with a sitting SBP ≥140 and \<180 mmHg, and a sitting DBP ≥90 and \<120 mmHg during the last two evaluations within the observation period.
  • Patients with PA who are eligible for drug treatment.
  • Diagnostic criteria for primary aldosteronism: (1) Hypertension or use of antihypertensive medications, with or without hypokalemia; (2) Screening test: Baseline plasma aldosterone to renin ratio (ARR) \>30 (ng/dl)/(ng/ml/h) or ARR \>2.4 (ng/dl)/(mU/L), with plasma aldosterone \>15 ng/dl and plasma renin activity \<1.0 ng/ml/h; (3) At least one confirmed test is positive: ① After a captopril test, plasma aldosterone decreases by \<30% or plasma aldosterone is ≥11 ng/dl, with suppressed renin activity; ② Sitting saline infusion test results in a plasma aldosterone ≥10 ng/dl.
  • eGFR ≥60 ml/ (min\*1.73m2).
  • Signed informed consent form.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.