Primary AldosteronismNCT07688928
Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
A study testing Finerenone in people with Primary Aldosteronism and Endocrine Hypertension, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism. It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism, Endocrine Hypertension
- What is being tested?
- Finerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Apr 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- History of hypertension (blood pressure >140/90 mm Hg), both newly detected and already established patients.
- Diagnosed case of primary aldosteronism (PA) based on a screening test (increased aldosterone renin ration (ARR) >70pmol/L) and confirmed by saline suppression test (post-saline PAC >170pmol/L, where PAC measured by immunoassay).
- Serum potassium ≥2.5 mmol/L.
Who cannot join
- Uncontrolled hypertension (>180/120 mm Hg).
- Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
- Participants already with mineralocorticoid receptor antagonist treatment.
- Patients receiving medications confounding PAC or PRC (glucocorticoids, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, clarithromycin, rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz) that cannot be discontinued 14 days prior to randomization or for the duration of treatment period.
- Abnormal renal function test: eGFR <60 ml/min-1.73m2.
- Serum potassium level >5 mmol/L.
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- Recent cardiovascular events like acute myocardial ischemia, heart failure with hospitalization, stroke or transient ischemic attack ≤3 months before the screening visit.
- Uncontrolled DM (HbA1C >12%)
- Hepatic insufficiency (Child-Pugh C)
- Addison's disease
- Pregnant and lactating women. Women with child bearing potential must agree to use adequate contraception during and until 2 month of the end of study period.
- Patient with other form of secondary HTN (e.g. renovascular HTN, Cushing syndrome, pheochromocytoma, coarctation of aorta etc.)
- Known hypersensitivity to the study drugs.
- Patients unwilling to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Endocrine HTN Clinic
Dhaka, 1000
Sharmin Jahan, PhD, +8801731061056, sharminendo@bsmmmu.edu.bd
Sharmin Jahan, PhD
About this study
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism.
It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.
- Conditions
- Primary Aldosteronism, Endocrine Hypertension
- Being tested
- Finerenone
- Keywords
- Primary Aldosteronism, Finerenone, Spironolactone
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
All participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Tab. Finerenone 10-40mg daily Receives: Drug: Finerenone |
| Spironolactone | Active comparator | Tab. Spironolactone 25-100mg daily Receives: Drug: Finerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Finerenone
daily dose of finerenone required for attainment of composite endpoints of target blood pressure (<140/90 mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
Measured: 12 month
Time required
Time required for attainment of composite endpoints of target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
Measured: 12 month
Secondary outcomes (2)
Change in Systolic and Diastolic Blood Pressure
Change in mean clinic systolic and diastolic blood pressure from baseline to the end of 48 weeks treatment period.
Measured: 12 month
Change in Blood pressure in ABPM
Change in mean systolic and diastolic blood pressure on ambulatory blood pressure monitoring (ABPM).
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start15 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharmin Jahan, Bangladesh Medical University
- Investigators
- Sharmin Jahan, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688928
- Sponsor's protocol ID
- PR-1418
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Finerenone Compared to Spironolactone in Treatment of Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT07688928
- Acronym / sponsor ID
- PR-1418
- Conditions
- Primary Aldosteronism, Endocrine Hypertension
- Keywords
- Primary Aldosteronism, Finerenone, Spironolactone
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the efficacy and safety of finerenone versus spironolactone in the treatment of hypertension due to primary aldosteronism.
It will be a randomized, double-blind, active-controlled, parallel-group clinical trial conducted at the Endocrine Hypertension Clinic, Department of Endocrinology, BSMMU. A total of 104 adult patients with confirmed primary aldosteronism will be enrolled and randomized equally to receive either finerenone (10-40 mg/day) or spironolactone (25-100mg/day) for 48 weeks. Study drugs will be titrated to achieve target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L). The primary efficacy outcome will be the time and daily dose required to attain this composite endpoint. Secondary outcomes include changes in clinic and ambulatory blood pressure, plasma aldosterone and renin levels, renal function (eGFR), urinary albumin excretion, left ventricular mass index, and quality of life. Safety outcomes will include adverse events, particularly hyperkalaemia and deterioration of renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneTab. Finerenone 10-40mg daily |
| Spironolactone | Active comparator | Drug: FinerenoneTab. Spironolactone 25-100mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years.
- History of hypertension (blood pressure >140/90 mm Hg), both newly detected and already established patients.
- Diagnosed case of primary aldosteronism (PA) based on a screening test (increased aldosterone renin ration (ARR) >70pmol/L) and confirmed by saline suppression test (post-saline PAC >170pmol/L, where PAC measured by immunoassay).
- Serum potassium ≥2.5 mmol/L.
Key exclusion criteria (14 listed)
- Uncontrolled hypertension (>180/120 mm Hg).
- Lateralized PA patients (aldosterone producing adenoma or unilateral hyperplasia) who want to undergo adrenalectomy or having aldosterone producing carcinoma.
- Participants already with mineralocorticoid receptor antagonist treatment.
- Patients receiving medications confounding PAC or PRC (glucocorticoids, sodium glucose co-transporter 2 inhibitors (SGLT-2i) or systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g. itraconazole, clarithromycin, rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz) that cannot be discontinued 14 days prior to randomization or for the duration of treatment period.
- Abnormal renal function test: eGFR <60 ml/min-1.73m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAll participants in Finerenone group will get Tab. Finerenone started at 10mg daily and titrated upto 40mg daily | Drug | Finerenone, Spironolactone |
Primary outcome
Dose of Finerenone
Time frame: 12 month
daily dose of finerenone required for attainment of composite endpoints of target blood pressure (<140/90 mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
Time required
Time frame: 12 month
Time required for attainment of composite endpoints of target blood pressure (<140/90mmHg) and unsuppressed plasma renin concentration (>15 mU/L) from baseline in participants with PA
2 secondary outcomes
Change in Systolic and Diastolic Blood Pressure
Time frame: 12 month
Change in Blood pressure in ABPM
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharmin Jahan, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Finerenone in people with Primary Aldosteronism and Endocrine Hypertension, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharmin Jahan, PhD (+8801731061056, sharminendo@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Finerenone (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.