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Calcium Channel Blocker

Amlodipine for Primary Aldosteronism (CCB-PA Trial)

Phase 2
Waitlist Available
Led By Anand Vaidya, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights

Summary

This trial is testing whether a calcium channel blocker can help people with a certain type of hypertension caused by an excess of aldosterone.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Amlodipine may cause swelling of the legs or ankles, fatigue, stomach pain, dizziness, flushing (feeling warm), palpitations (irregular heartbeat), and in rare cases more serious heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24-hour Urinary Aldosterone Excretion Rate
Change in Plasma Aldosterone Concentration
Secondary outcome measures
Acute change in Plasma Aldosterone Concentration
Acute change in Systolic Blood pressure

Side effects data

From 2019 Phase 4 trial • 44 Patients • NCT02034435
13%
IV infiltration or malfunction
6%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aim 2- Amlodipine
Aim 1- Low Sodium
Aim 2- Eplerenone
Aim 1- High Sodium

Trial Design

1Treatment groups
Experimental Treatment
Group I: AmlodipineExperimental Treatment1 Intervention
Amlodipine (dose 10 mg, once daily)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amlodipine
2004
Completed Phase 4
~40680

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Conn Syndrome, or primary aldosteronism, is treated by reducing aldosterone production or blocking its effects. Common treatments include mineralocorticoid receptor antagonists like spironolactone and eplerenone, which block aldosterone's action, reducing sodium retention and potassium loss. Calcium channel antagonists, such as verapamil, inhibit calcium channels in the adrenal gland's zona glomerulosa, reducing aldosterone synthesis. This approach is crucial for Conn Syndrome patients as it targets the root cause, improving blood pressure control and electrolyte balance.
Hemodynamic responses to verapamil monotherapy in patients with renal disease.Calcium antagonists and stimulus-secretion coupling of aldosterone.Tolvaptan for Primary Aldosteronism and Autosomal Dominant Polycystic Kidney Disease: A Case Report.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,628 Previous Clinical Trials
11,474,625 Total Patients Enrolled
University of MichiganOTHER
1,817 Previous Clinical Trials
6,387,347 Total Patients Enrolled
Anand Vaidya, MDPrincipal Investigator - Brigham and Women's Hospital
Boston Children's Hospital, Dana-Farber Cancer Institute
Harvard Medical Sch (Medical School)
Brigham & Women'S Hospital (Residency)
2 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Amlodipine (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04179019 — Phase 2
Conn Syndrome Research Study Groups: Amlodipine
Conn Syndrome Clinical Trial 2023: Amlodipine Highlights & Side Effects. Trial Name: NCT04179019 — Phase 2
Amlodipine (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04179019 — Phase 2
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