NCT04179019: CCB-PA

Calcium Channel Blockade in Primary Aldosteronism

Completed Phase 2 Results posted Last updated 15 April 2025

What this trial tests

Phase 2 trial testing Amlodipine in Primary Aldosteronism in 15 participants. Completed in 30 December 2023.

Timeline

1 September 2020

Primary endpoint
30 December 2023

30 December 2023

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 September 2020
Primary completion	30 December 2023
Estimated completion	30 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Amlodipine (amlodipine) — full drug profile →

Conditions studied

• Primary Aldosteronism — all drugs for Primary Aldosteronism →
• Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) — all drugs for Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral) →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 80, any sex, with Primary Aldosteronism or Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in 24-hour Urinary Aldosterone Excretion Rate Primary · Baseline and 2 weeks of amlodipine therapy

Change in 24h urinary aldosterone excretion rate in response to maximal amlodipine therapy

Group	Value	95% CI
Amlodipine	0.21	± 4.94

Change in Plasma Aldosterone Concentration Primary · Baseline and 2 weeks of amlodipine therapy

Change in plasma aldosterone concentration in response to maximal amlodipine therapy

Group	Value	95% CI
Amlodipine	9.81	± 6.87

Acute Change in Plasma Aldosterone Concentration Secondary · Baseline plasma aldosterone concentration before amlodipine therapy and 6 hours post-amlodipine dose, compared to baseline plasma aldosterone after 2 weeks of amlodipine therapy and 6 hours post-amlodipine therapy.

Change in plasma aldosterone concentration after a single dose of amlodipine, before and after 2 weeks of amlodipine therapy

Group	Value	95% CI
Amlodipine	-0.86	± 4.51

Adverse events — posted to ClinicalTrials.gov

Time frame: During the course of the study, ranging from 2-8 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Amlodipine

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (4 terms — click to expand)

Reaction	System	Amlodipine
incidental abnormal labs	Endocrine disorders	—
elevated blood pressure	Vascular disorders	—
atypical chest pain unrelated to study protocol	Cardiac disorders	—
hematuria unrelated to the study protocol or procedures	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT04179019 adverse events section.

Sponsor's own description

This pilot study explore whether the calcium channel blocker amlodipine can lower aldosterone levels in people with primary aldosteronism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.