An interventional study of inclisiran and Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) in Primary Aldosteronism, sponsored by Third Military Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Third Military Medical University · Not applicable, Interventional, and Treatment
Primary aldosteronism represents one of the leading causes of resistant hypertension. Circulating cholesterol is established as the exclusive substrate for adrenal aldosterone synthesis, and statins, which suppress cholesterol production, are currently widely applied in clinical settings. Emerging clinical evidence has demonstrated that in patients with essential hypertension, the plasma aldosterone level decreased by 43% (from 13.9 ng/dL to 7.9 ng/dL) after treatment with PCSK9 inhibitors. However, the effect of PCSK9 inhibitors with superior lipid-lowering efficacy combined with amlodipine besylate on aldosterone levels remains elusive. The present clinical trial adopted inclisiran, a PCSK9 inhibitor with well-documented clinical safety and robust lipid-lowering effects, in combination with amlodipine besylate. Through randomized grouping intervention and follow-up, this study aimed to compare the differential effects of two therapeutic regimens-inclisiran-based therapy and statin-based therapy-on plasma aldosterone levels, as well as improvements in a spectrum of clinical parameters including blood pressure , serum potassium and so on in patients with primary aldosteronism. The outcomes of this trial are expected to provide novel and more effective pharmacological strategies for the management of primary aldosteronism.
196 studies on the registry are indexed under Hyperaldosteronism; 88 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 93 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Third Military Medical University is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
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Participants receive inclisiran subcutaneously plus oral amlodipine besylate and spironolactone
Drug: inclisiran · Drug: Spironolactone (drug) · Drug: Amlodipine besylate
Participants receive statin plus oral amlodipine besylate and spironolactone
Drug: Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin) · Drug: Spironolactone (drug) · Drug: Amlodipine besylate
Subcutaneous inclisiran
oral Lipophilic statins (such as Simvastatin, Atorvastatin, Fluvastatin, Lovastatin,Pitavastatin)
oral Spironolactone
oral Amlodipine besylate
Change from baseline in plasma aldosterone level
Time frame: 24 weeks after randomization
Change from baseline in systolic and diastolic blood pressure
Time frame: 24 weeks after randomization
Change from baseline in plasma renin concentration
Time frame: 24 weeks after randomization
Change from baseline in 24-hour urinary aldosterone
Time frame: 24 weeks after randomization
Change from baseline in serum potassium level
Time frame: 24 weeks after randomization
Change from baseline in plasma lipid
Time frame: 24 weeks after randomization
Change from baseline in glucose
Time frame: 24 weeks after randomization
Start is estimated for Oct 2026; primary completion for Aug 2027, 10 months later.
Of 36 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Inclisiran
Third Military Medical University