Trial · NCT02525796
Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
NCT02525796, Phase 2, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2023-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism. Trials, record NCT02525796. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02525796
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Alternative Medical Therapies in Primary Hyperparathyroidism
- NCT number
- NCT02525796
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Primary Hyperparathyroidism
- Interventions
- eplerenone, amiloride, Placebo, Cinacalcet
- First posted
- 2015-08-17
- Last updated
- 2023-05-03
- Results first posted
- 2023-05-03
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Parathyroid Hormone Levels | Change in circulating PTH levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (PTH at 4 weeks minus PTH at baseline) | Change in circulating PTH levels before and after 4 weeks of double-blinded intervention when compared to placebo |
| Secondary | Change in Calcium Levels | Change in serum calcium levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (calcium at 4 weeks minus calcium at baseline) | Change in serum calcium levels before and after intervention when compared to placebo |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Parathyroid Hormone Levels | Change in circulating PTH levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (PTH at 4 weeks minus PTH at baseline) | Number of participants who completed the 4 week double-blinded monotherapy intervention | pg/mL | MEDIAN |
| SECONDARY | Change in Calcium Levels | Change in serum calcium levels before and after 4 weeks of double-blinded monotherapy intervention when compared to placebo (calcium at 4 weeks minus calcium at baseline) | patients with primary hyperparathyroidism receiving double-blinded monotherapy for 4 weeks | mg/dL | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Parathyroid Hormone Levels | Eplerenone | 4.0 | Inter-Quartile Range -10.4 to 10.4 | pg/mL | |
| Change in Parathyroid Hormone Levels | Amiloride | -3.7 | Inter-Quartile Range -11.4 to 8.7 | pg/mL | |
| Change in Parathyroid Hormone Levels | Placebo | 0.8 | Inter-Quartile Range -3.6 to 8.3 | pg/mL | |
| Change in Calcium Levels | Eplerenone | 0.1 | Inter-Quartile Range -0.1 to 03 | mg/dL | |
| Change in Calcium Levels | Amiloride | 0.0 | Inter-Quartile Range -0.3 to 0.1 | mg/dL | |
| Change in Calcium Levels | Placebo | 0.1 | Inter-Quartile Range -0.1 to 0.4 | mg/dL |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization to Monotherapy for 4 Weeks | STARTED | Eplerenone | 14 | |
| Randomization to Monotherapy for 4 Weeks | STARTED | Amiloride | 14 | |
| Randomization to Monotherapy for 4 Weeks | STARTED | Placebo | 13 | |
| Randomization to Monotherapy for 4 Weeks | COMPLETED | Eplerenone | 12 | |
| Randomization to Monotherapy for 4 Weeks | COMPLETED | Amiloride | 12 | |
| Randomization to Monotherapy for 4 Weeks | COMPLETED | Placebo | 12 | |
| Randomization to Monotherapy for 4 Weeks | NOT COMPLETED | Eplerenone | 2 | |
| Randomization to Monotherapy for 4 Weeks | NOT COMPLETED | Amiloride | 2 | |
| Randomization to Monotherapy for 4 Weeks | NOT COMPLETED | Placebo | 1 | |
| Open-label Addition of Cinacalcet | STARTED | Eplerenone | 12 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events24
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 | low egfr | Renal and urinary disorders | Eplerenone | 0 | 14 | 0 |
| other | low egfr | Renal and urinary disorders | Amiloride | 0 | 14 | 0 |
| other | low egfr | Renal and urinary disorders | Placebo | 1 | 13 | 1 |
| other | low egfr | Renal and urinary disorders | Eplerenone + Cinacalcet | 1 | 12 | 1 |
| other | low egfr | Renal and urinary disorders | Amiloride + Cinacalcet | 0 | 12 | 0 |
| other | low egfr | Renal and urinary disorders | Placebo + Cinacalcet | 0 | 12 | 0 |
| other | hyperkalemia | General disorders | Eplerenone | 1 | 14 | 1 |
| other | hyperkalemia | General disorders | Amiloride | 1 | 14 | 1 |
| other | hyperkalemia | General disorders | Placebo | 0 | 13 | 0 |
| other | hyperkalemia | General disorders | Eplerenone + Cinacalcet | 0 | 12 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eplerenone | 0 | 14 |
| Total, all-cause mortality | Amiloride | 0 | 14 |
| Total, all-cause mortality | Placebo | 0 | 13 |
| Total, all-cause mortality | Eplerenone + Cinacalcet | 0 | 12 |
| Total, all-cause mortality | Amiloride + Cinacalcet | 0 | 12 |
| Total, all-cause mortality | Placebo + Cinacalcet | 0 | 12 |
| Total, other adverse events | Eplerenone | 1 | 14 |
| Total, other adverse events | Amiloride | 1 | 14 |
| Total, other adverse events | Placebo | 1 | 13 |
| Total, other adverse events | Eplerenone + Cinacalcet | 2 | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT02525796
GET https://conductscience.org/api/trials/v1/NCT02525796/flow?page=2