Phase 2
N=15
Calcium Channel Blockade in Primary Aldosteronism
Primary Aldosteronism · Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Bottom Line
View on ClinicalTrials.gov: NCT04179019 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in 24-hour Urinary Aldosterone Excretion Rate — 0.21 mcg/24h — p=0.96
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amlodipine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 24-hour Urinary Aldosterone Excretion Rate |
0.21 | 0.96 |
| PRIMARY Change in Plasma Aldosterone Concentration |
9.81 | 0.29 |
| SECONDARY Acute Change in Plasma Aldosterone Concentration |
-0.86 | 0.83 |
Summary
This pilot study explore whether the calcium channel blocker amlodipine can lower aldosterone levels in people with primary aldosteronism.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of primary aldosteronism
- Idiopathic bilateral hyperaldosteronism subtype based on adrenal venous sampling
- Primary aldosteronism treated with medical therapy (not surgery)
- Plasma renin activity 1.0 ng/mL/h
- Anemia
- leukopenia
- thrombocytopenia
- pregnant
- breastfeeding
Data sourced from ClinicalTrials.gov (NCT04179019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.