Primary AldosteronismPhase 4STOP-PANCT06523465
Statin Combined with Amlodipine Treats Primary Aldosteronism
A Phase 4 study testing Simvastatin combined with Amlodipine besylate, Simvastatin combined with Spironolactone and Amlodipine besylate. and Amlodipine besylate combined Spironolactone in people with Primary Aldosteronism and Statin, run by Third Military Medical University at 1 site in China.
Trial summary
The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Aldosteronism, Statin, Mineralocorticoid Receptor Antagonist
- What is being tested?
- Simvastatin combined with Amlodipine besylate, Simvastatin combined with Spironolactone and Amlodipine besylate. and Amlodipine besylate combined Spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2024to 30 Sep 2026
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary aldosteronism
Who cannot join
- Allergy to drugs in this study
- Pregnancy
- Severe liver and kidney dysfunction
- Mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
No. 10 Changjiang River Branch, Yuzhong District，Chongqing, China
Chongqing, Chongqing Municipality, 400042
Jingjing Wang, +86-02368757140, wii1017@163.com
About this study
Official title: A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment
The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.
- Being tested
- Simvastatin combined with Amlodipine besylate, Simvastatin combined with Spironolactone and Amlodipine besylate., Amlodipine besylate combined Spironolactone
- Keywords
- primary aldosteronism, hypertension, Statin
- Medical subject headings
- Hyperaldosteronism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin combined with Amlodipine besylateDrug
6-month treatment of Simvastatin combined with Amlodipine besylate
Simvastatin combined with Spironolactone and Amlodipine besylate.Drug
6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate.
Amlodipine besylate combined SpironolactoneDrug
6-month treatment of Amlodipine besylate combined with Spironolactone
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin combined with Amlodipine besylate | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months Receives: Drug: Simvastatin combined with Amlodipine besylate |
| Simvastatin combined with Spironolactone and Amlodipine besylate. | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months Receives: Drug: Simvastatin combined with Spironolactone and Amlodipine besylate. |
| Amlodipine besylate combined with Spironolactone | Experimental | after 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months Receives: Drug: Amlodipine besylate combined Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in plasma aldosterone levels
blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml)
Measured: 6 month
changes in 24-hour urinary aldosterone levels
24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h)
Measured: 6 month
Secondary outcomes (5)
changes in office blood pressure and home blood pressure
Record office blood pressure at baseline and at follow-up after medical treatment (mmHg), and compare between groups and within groups
Measured: 6 month
changes in serum potassium levels
blood samples are collected at baseline and 6 months after treatment to measure serum potassium levels， and compare between groups and within groups (mmol/L)
Measured: 6 month
changes in serum renin level
blood samples are collected at baseline and 6 months after treatment to measure serum renin levels, and compare between groups and within groups (mU/L)
Measured: 6 month
changes in plasma cholesterol levels
blood samples are collected at baseline and 6 months after treatment to measure plasma cholesterol levels， and compare between groups and within groups (mmol/L)
Measured: 6 month
changes in blood glucose
blood samples are collected at baseline and 6 months after treatment to measure blood glucose， and compare between groups and within groups (mmol/L)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start10 Sep 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Sep 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiming Zhu, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523465
- Sponsor's protocol ID
- STOP-PA
- Acronym
- STOP-PA
- Status last verified
- Nov 2024
- First submitted
- 17 Jul 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment
- ClinicalTrials.gov ID
- NCT06523465
- Acronym / sponsor ID
- STOP-PA / STOP-PA
- Keywords
- primary aldosteronism, hypertension, Statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Jul 2024 (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 drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simvastatin combined with Amlodipine besylate | Experimental | Drug: Simvastatin combined with Amlodipine besylateafter 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Amlodipine besylate for 6 months |
| Simvastatin combined with Spironolactone and Amlodipine besylate. | Experimental | Drug: Simvastatin combined with Spironolactone and Amlodipine besylate.after 1:1 randomization, 60 patients with primary aldosteronism were treated with Simvastatin combined with Spironolactone and Amlodipine besylate for 6 months |
| Amlodipine besylate combined with Spironolactone | Experimental | Drug: Amlodipine besylate combined Spironolactoneafter 1:1 randomization, 60 patients with primary aldosteronism were treated with Amlodipine besylate combined with Spironolactone for 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of primary aldosteronism
Key exclusion criteria (4 listed)
- Allergy to drugs in this study
- Pregnancy
- Severe liver and kidney dysfunction
- Mental illness
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 |
|---|---|---|
| Simvastatin combined with Amlodipine besylate6-month treatment of Simvastatin combined with Amlodipine besylate | Drug | Simvastatin combined with Amlodipine besylate |
| Simvastatin combined with Spironolactone and Amlodipine besylate.6-month treatment of Simvastatin combined with Spironolactone and Amlodipine besylate. | Drug | Simvastatin combined with Spironolactone and Amlodipine besylate. |
| Amlodipine besylate combined Spironolactone6-month treatment of Amlodipine besylate combined with Spironolactone | Drug | Amlodipine besylate combined with Spironolactone |
Primary outcome
changes in plasma aldosterone levels
Time frame: 6 month
blood samples are collected at baseline and 6 months after treatment to measure plasma aldosterone levels， and compare between groups and within groups (pg/ml)
changes in 24-hour urinary aldosterone levels
Time frame: 6 month
24 hours urine are collected at baseline and 6 months after treatment to measure 24-hour urinary aldosterone， and compare between groups and within groups(pmol/24h)
5 secondary outcomes
changes in office blood pressure and home blood pressure
Time frame: 6 month
changes in serum potassium levels
Time frame: 6 month
changes in serum renin level
Time frame: 6 month
changes in plasma cholesterol levels
Time frame: 6 month
changes in blood glucose
Time frame: 6 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 22 Nov 2024.
- 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.
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 Simvastatin combined with Amlodipine besylate, Simvastatin combined with Spironolactone and Amlodipine besylate. and Amlodipine besylate combined Spironolactone in people with Primary Aldosteronism and Statin, run by Third Military Medical University 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 1 inclusion and 4 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 22 Nov 2024. 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?
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 sun fang (+862368729587, sun_fang2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in plasma aldosterone levels (time frame: 6 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 22 Nov 2024.