Trial · NCT04179019
Calcium Channel Blockade in Primary Aldosteronism
NCT04179019, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2025-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Calcium Channel Blockade in Primary Aldosteronism. Trials, record NCT04179019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04179019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Calcium Channel Blockade in Primary Aldosteronism
- NCT number
- NCT04179019
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Primary Aldosteronism, Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
- Interventions
- Amlodipine
- First posted
- 2019-11-26
- Last updated
- 2025-04-15
- Results first posted
- 2025-04-15
- Limitations and caveats
The major limitations of this pilot study was that it was intended to be a small proof-of-concept study in 15 people with advanced primary aldosteronism given the multi-morbidity nature of this population and difficulty in enrolling them. Further, this was a single-arm study without a control group. Finally, largely influenced by the concurrent COVID pandemic in 2020-2022, only 2 participants completed the pilot study, therefore validity of the results is low.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 24-hour Urinary Aldosterone Excretion Rate | Baseline and 2 weeks of amlodipine therapy | Change in 24h urinary aldosterone excretion rate in response to maximal amlodipine therapy |
| Primary | Change in Plasma Aldosterone Concentration | Baseline and 2 weeks of amlodipine therapy | Change in plasma aldosterone concentration in response to maximal amlodipine therapy |
| Secondary | Acute Change in Plasma Aldosterone Concentration | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in 24-hour Urinary Aldosterone Excretion Rate | Baseline and 2 weeks of amlodipine therapy | mcg/24h | MEAN | |
| PRIMARY | Change in Plasma Aldosterone Concentration | Baseline and 2 weeks of amlodipine therapy | ng/dL | MEAN | |
| SECONDARY | Acute Change in Plasma Aldosterone Concentration | 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. | ng/dL | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in 24-hour Urinary Aldosterone Excretion Rate | Amlodipine | 0.21 | Standard Deviation 4.94 | mcg/24h | |
| Change in Plasma Aldosterone Concentration | Amlodipine | 9.81 | Standard Deviation 6.87 | ng/dL | |
| Acute Change in Plasma Aldosterone Concentration | Amlodipine | -0.86 | Standard Deviation 4.51 | ng/dL |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amlodipine | 15 | |
| Overall Study | COMPLETED | Amlodipine | 2 | |
| Overall Study | NOT COMPLETED | Amlodipine | 13 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | elevated blood pressure | Vascular disorders | Amlodipine | 1 | 15 | 1 |
| other | incidental abnormal labs | Endocrine disorders | Amlodipine | 2 | 15 | 2 |
| other | atypical chest pain unrelated to study protocol | Cardiac disorders | Amlodipine | 1 | 15 | 1 |
| other | hematuria unrelated to the study protocol or procedures | Renal and urinary disorders | Amlodipine | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amlodipine | 0 | 15 |
| Total, other adverse events | Amlodipine | 4 | 15 |
| Total, serious adverse events | Amlodipine | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04179019
GET https://conductscience.org/api/trials/v1/NCT04179019/registered