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New treatment option for Primary Aldosteronism
Official title Finerenone for Patients With Primary Aldosteronism (FAIRY)
ClinicalTrials.gov ID: NCT06457074
What this study is testing
What is Finerenone Oral Tablet?
Finerenone Oral Tablet is an investigational medicine, being studied as a potential treatment for primary aldosteronism.
Also referred to as Finerenone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Using spironolactone as the control, to assess the efficacy and safety of finerenone in patients with primary aldosteronism(PA).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- . Aged between 18-75, male or female;
- . With confirmed PA diagnosis (screening positive and at least one confirmatory test is positive); NOTE: Screening positive was defined as plasma...
- . Not taking any antihypertensive drugs or on a stable regimen of antihypertensive agents(Limited to alpha-adrenergic receptor blockers and calcium...
- . With a mean seated office SBP≥140 or DBP≥90 mmHg;
- . Able and willing to give informed consent for participation in the clinical study;
You likely can't join if
- Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
- Has planned surgery within 3 months;
- With a mean seated office SBP ≥ 180mmHg or DBP ≥ 110mmHg before randomization; Note: Mean seated BP is defined as the average of 3 seated BP...
- Night shift workers;
- Has a body mass index(BMI) ≥30 kg/m2 at screening;
- Has uncontrolled diabetes with fasting blood glucose(FBG)≥13.3mmol/L at screening;
See the full eligibility criteria
- . Aged between 18-75, male or female;
- . With confirmed PA diagnosis (screening positive and at least one confirmatory test is positive); NOTE: Screening positive was defined as plasma aldosterone-to-renin ratio (ARR) ≥ 20(pg/ml)/(μIU/ml) or...
- . Not taking any antihypertensive drugs or on a stable regimen of antihypertensive agents(Limited to alpha-adrenergic receptor blockers and calcium channel blockers.) for more than four weeks before screening;
- . With a mean seated office SBP≥140 or DBP≥90 mmHg;
- . Able and willing to give informed consent for participation in the clinical study;
- Has a plan to conduct PA subtype classification(eg. Adrenal vein sampling, PET-CT) in 3 months；
- Has planned surgery within 3 months;
- With a mean seated office SBP ≥ 180mmHg or DBP ≥ 110mmHg before randomization; Note: Mean seated BP is defined as the average of 3 seated BP measurements at any single clinical site visit. If the patient did not take...
- Night shift workers;
- Has a body mass index(BMI) ≥30 kg/m2 at screening;
- Has uncontrolled diabetes with fasting blood glucose(FBG)≥13.3mmol/L at screening;
- Has uncontrolled chronic diseases;
- Has known other secondary hypertension (eg, renal artery stenosis, Cushing's syndrome, pheochromocytoma, or aortic coarctation) except subclinical Cushing's syndrome;
- Has known and documented heart failure (New York Heart Association (NYHA) class III or IV), liver transaminase levels were more than 2 times higher than the upper limit of normal;
- Has had CABG or other major cardiac surgery (eg, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
- Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
- Has poor compliance that can not fully participating in the study;
- Has hyperkalemia with serum potassium \> 5.0mmol/L without potassium supplementation;
- Has a history of uncontrolled malignant tumor;
- Has more than 20mmHg difference of seated office SBP in both arms;
- Is not willing or not able to stop taking sex hormones, glucocorticoids, non-steroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or antidepressants;
- Is pregnant, breastfeeding, or planning to become pregnant during the study;
- Complicated with severe mental illness;
- Has had prior solid organ transplant and/or cell transplants;
- Has a history of allergy to Finerenone or spironolactone;
- Has typical consumption of ≥15 alcoholic drinks weekly. Note: 1 drink of alcohol is equivalent to 360ml beer, 45ml spirits, or 150ml wine;
- Has participated in another clinical study involving any investigational drug within 30 days prior to screening；
- Female of childbearing potential refuses to use non-hormonal contraception methods during the study period;
- Refuse to stop eating grapefruit or grapefruit juice during treatment with Finerenone;
- Other situations that the investigator assesses the subject as unable to complete the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.