Amlodipine for Primary Aldosteronism (CCB-PA Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByAnand Vaidya, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests if the drug amlodipine can help lower aldosterone levels in patients with a type of high blood pressure called primary aldosteronism. These patients have a condition where their adrenal glands produce too much aldosterone due to calcium channel mutations. By blocking these channels, amlodipine may reduce aldosterone production and improve blood pressure control. Amlodipine is a long-acting medication widely used for lowering elevated blood pressure and has shown cardiovascular benefits when combined with other blood pressure-lowering agents.

Eligibility Criteria

This trial is for adults with primary aldosteronism, a condition causing high blood pressure due to excess hormone production. Participants must have low plasma renin activity and be diagnosed with idiopathic bilateral hyperaldosteronism. They should be on medical therapy, not surgery, and able to switch from current calcium channel blockers or mineralocorticoid receptor antagonists if needed.

Participant Groups

The study tests Amlodipine, a calcium channel blocker, as a potential targeted treatment for reducing aldosterone production in patients with specific genetic mutations associated with primary aldosteronism.

1Treatment groups

Experimental Treatment

Group I: AmlodipineExperimental Treatment1 Intervention

Amlodipine (dose 10 mg, once daily)

Amlodipine is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸 Approved in United States as Norvasc for: