Primary AldosteronismPhase 4FAVORNCT06164379
Efficacy and Safety of Finerenone vs. Spironolactone in Patients With Primary Aldosteronism
A Phase 4 study testing Finerenone and Spironolactone in people with Primary Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Finerenone and Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2023to 16 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other kinds of secondary hypertension
- Obesity with BMI>30kg/m²（BMI= kg/㎡）
- Serum potassium > 5.5 mmol/L
- Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）
- Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR < 25 ml/(min * 1.73㎡);
- Abnormal liver function: ALT and AST ≥ 2 × ULN；
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- Cardiac insufficiency, acute myocardial infarction, stroke or other acute cardiovascular events within 6 months;
- Take spironolactone, guanethidine or reserpine 30 days before enrollment;
- Known or suspected tumor; Other autoimmune diseases, uncontrolled infectious diseases, serious respiratory, blood and nervous system diseases;
- There is a pregnancy plan in pregnancy or 3 months before and after treatment. Breast-feeding women;
- Those who have mental illness, alcohol or drug abuse and cannot cooperate with treatment.
- Be allergic to the study drugs
- Without Signed the informed consent
- Anticipating another clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
Read the detailed description
- Study design: This is a multi-center, double-blind, randomized, non-inferiority trial of finerenone vs. spironolactone in hypertensive patients with primary aldosteronism (PA). All patients will be randomized into finerenone group (Intervention group) and spironolactone group (Control group).
- Objective: To compare the antihypertensive effects and Correction of hypokalemia in patients with PA.
- Medicine: Finerenone (10mg tablet) and the matching placebo; Spironolactone (20mg tablet) and the matching placebo.
- Study population: Men or women aged from18 years to 75 years old, with history of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks, were diagnosed PA 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.
- Randomized and treatment: The initial dose of finerenone group is 10mg and spironolactone group is 20mg, respectively (week 0). For patients not meeting clinic blood pressure < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone or spironolactone should be increased one tablet at every visit (week 2, week 4). The whole treatment period was 8 weeks.
- Follow up: After the induction period of two weeks and meeting the inclusion criteria, 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 finernone 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. 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.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Department of Hypertension, Ruijin Hospital, Shanghai, China.
- Conditions
- Primary Aldosteronism
- Being tested
- Finerenone, Spironolactone
- Keywords
- Primary Aldosteronism, Spironolactone, Finerenone
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
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.
SpironolactoneDrug
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 group | Role | What they receive |
|---|---|---|
| Finerenone group | Experimental | 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. Receives: Drug: Finerenone |
| Spironolactone group | Active comparator | 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. Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of 24-hour ambulatory systolic blood pressure from the baseline level.
24-hour ambulatory systolic blood pressure
Measured: 8 weeks
The proportion of patients with normal serum potassium level.
serum potassium level
Measured: 8 weeks
Secondary outcomes (5)
The change of clinic systolic and diastolic blood pressure from the baseline level.
clinic systolic and diastolic blood pressure
Measured: 8 weeks
The change of other components of 24-hour ambulatory blood pressure from the baseline level.
other components of 24-hour ambulatory blood pressure
Measured: 8 weeks
The changes of plasma renin and aldosterone from the baseline levels.
plasma renin and aldosterone
Measured: 8 weeks
The change of urinary microalbumin creatinine ratio (ACR) from the baseline level.
urinary microalbumin creatinine ratio
Measured: 8 weeks
The change of estimate glomerular filtration rate from the baseline level.
estimate glomerular filtration rate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start16 Dec 2023 (estimated)
- Primary completion16 Dec 2024 (estimated)
- Study completion16 Dec 2024 (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.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiguang Wang, MD. PhD, Study director, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164379
- Sponsor's protocol ID
- FAVOR
- Acronym
- FAVOR
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 11 Dec 2023
- 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 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized Controlled Study of Finerenone vs. Spironolactone in Hypertensive Patients With Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT06164379
- Acronym / sponsor ID
- FAVOR / FAVOR
- Conditions
- Primary Aldosteronism
- Keywords
- Primary Aldosteronism, Spironolactone, Finerenone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 16 Dec 2023 (estimated)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 11 Dec 2023 (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.
To study the efficacy and safety of finerenone vs. spironolactone in patients with primary aldosteronism
Detailed description
- Study design: This is a multi-center, double-blind, randomized, non-inferiority trial of finerenone vs. spironolactone in hypertensive patients with primary aldosteronism (PA). All patients will be randomized into finerenone group (Intervention group) and spironolactone group (Control group).
- Objective: To compare the antihypertensive effects and Correction of hypokalemia in patients with PA.
- Medicine: Finerenone (10mg tablet) and the matching placebo; Spironolactone (20mg tablet) and the matching placebo.
- Study population: Men or women aged from18 years to 75 years old, with history of hypertension, Clinic DBP <110 mmHg, SBP <180 mmHg without any antihypertensive drugs for 2 weeks, were diagnosed PA 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.
- Randomized and treatment: The initial dose of finerenone group is 10mg and spironolactone group is 20mg, respectively (week 0). For patients not meeting clinic blood pressure < 140/90mmHg and the serum potassium ≥ 3.5 mmol/L, the dose of finerenone or spironolactone should be increased one tablet at every visit (week 2, week 4). The whole treatment period was 8 weeks.
- Follow up: After the induction period of two weeks and meeting the inclusion criteria, 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 finernone 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. 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.
- Organization: The Centre for Epidemiological Studies and Clinical Trials, Department of Hypertension, Ruijin Hospital, Shanghai, China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Finerenone group | Experimental | Drug: FinerenoneAfter 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. |
| Spironolactone group | Active comparator | Drug: SpironolactoneAfter 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Other kinds of secondary hypertension
- Obesity with BMI>30kg/m²（BMI= kg/㎡）
- Serum potassium > 5.5 mmol/L
- Serious hypertension（msSBP≥180mmHg, and/or msDBP≥110mmHg）
- Abnormal renal function: serum creatinine ≥ 2 × ULN or eGFR < 25 ml/(min * 1.73㎡);
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 |
|---|---|---|
| FinerenoneAt 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. | Drug | Finerenone group |
| SpironolactoneAt 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. | Drug | Spironolactone group |
Primary outcome
The change of 24-hour ambulatory systolic blood pressure from the baseline level.
Time frame: 8 weeks
24-hour ambulatory systolic blood pressure
The proportion of patients with normal serum potassium level.
Time frame: 8 weeks
serum potassium level
5 secondary outcomes
The change of clinic systolic and diastolic blood pressure from the baseline level.
Time frame: 8 weeks
The change of other components of 24-hour ambulatory blood pressure from the baseline level.
Time frame: 8 weeks
The changes of plasma renin and aldosterone from the baseline levels.
Time frame: 8 weeks
The change of urinary microalbumin creatinine ratio (ACR) from the baseline level.
Time frame: 8 weeks
The change of estimate glomerular filtration rate from the baseline level.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- 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. This study is not recruiting at the moment.
Jiguang Wang, MD. PhD study director
Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone and Spironolactone in people with Primary Aldosteronism, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiguang Wang, MD. PhD (+86-2164370045 ext. 610911, jiguangw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of 24-hour ambulatory systolic blood pressure from the baseline level. (time frame: 8 weeks). 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 11 Dec 2023.