Trial · NCT02354352
Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
NCT02354352, Phase 3, Completed, Ohio State University; results first posted 2019-09-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy. Trials, record NCT02354352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02354352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
- NCT number
- NCT02354352
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 52 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- Eplerenone, Spironolactone
- First posted
- 2015-02-03
- Last updated
- 2019-10-07
- Results first posted
- 2019-09-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Left Ventricular Strain | 12 months | a sensitive measure of heart muscle function |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Left Ventricular Strain | 12 months | One patient in the spironolactone group did not receive a follow-up MRI. | Percent change in circumference | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Left Ventricular Strain | Eplerenone | 0.2 | Inter-Quartile Range -0.2 to 0.7 | Percent change in circumference | |
| Left Ventricular Strain | Spironolactone | 0.4 | Inter-Quartile Range -0.4 to 1.0 | Percent change in circumference |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eplerenone | 26 | |
| Overall Study | STARTED | Spironolactone | 26 | |
| Overall Study | 2 Weeks | Eplerenone | 26 | |
| Overall Study | 2 Weeks | Spironolactone | 25 | |
| Overall Study | 1 Month | Eplerenone | 24 | |
| Overall Study | 1 Month | Spironolactone | 23 | |
| Overall Study | 2 Months | Eplerenone | 24 | |
| Overall Study | 2 Months | Spironolactone | 22 | |
| Overall Study | 3 Months | Eplerenone | 25 | |
| Overall Study | 3 Months | Spironolactone | 23 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events14
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 | Rash | Skin and subcutaneous tissue disorders | Eplerenone | 1 | 26 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Spironolactone | 0 | 26 | 0 |
| other | Nausea | Gastrointestinal disorders | Eplerenone | 0 | 26 | 0 |
| other | Nausea | Gastrointestinal disorders | Spironolactone | 2 | 26 | 2 |
| other | Gynecomastia | Endocrine disorders | Eplerenone | 0 | 26 | 0 |
| other | Gynecomastia | Endocrine disorders | Spironolactone | 1 | 26 | 1 |
| other | Nephrolithiasis | Renal and urinary disorders | Eplerenone | 1 | 26 | 1 |
| other | Nephrolithiasis | Renal and urinary disorders | Spironolactone | 0 | 26 | 0 |
| serious | Accidental Drowning | Injury, poisoning and procedural complications | Eplerenone | 1 | 26 | 1 |
| serious | Accidental Drowning | Injury, poisoning and procedural complications | Spironolactone | 0 | 26 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eplerenone | 2 | 26 |
| Total, all-cause mortality | Spironolactone | 0 | 26 |
| Total, other adverse events | Eplerenone | 2 | 26 |
| Total, other adverse events | Spironolactone | 3 | 26 |
| Total, serious adverse events | Eplerenone | 3 | 26 |
| Total, serious adverse events | Spironolactone | 2 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31549577 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eplerenone vs Spironolactone: deaths from any cause | Trial comparisons |
| Eplerenone vs Spironolactone: serious adverse events | Trial comparisons |
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/NCT02354352
GET https://conductscience.org/api/trials/v1/NCT02354352/registered