CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Eplerenone +1 moredrug
Likely dose
Eplerenone 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02354352
NCT02354352Phase 3Completed
CompareCT.gov

Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy

Ohio State University·interventional·Posted Feb 3, 2015·Updated Oct 7, 2019

In Brief

A Phase 3 clinical trial evaluating Eplerenone and Spironolactone for Duchenne Muscular Dystrophy. Completed, enrolled 52 participants across 6 sites.

Detailed Summary

The study is to demonstrate non-inferiority of spironolactone vs. eplerenone in preserving cardiac and pulmonary function in patients with preserved LV ejection fraction. Males with Duchenne muscular dystrophy (DMD) confirmed clinically and by mutation analysis will be enrolled. Subjects will be randomized to either eplerenone or spironolactone. Subjects will use a drug diary to record daily compliance of taking the study medication as well as any concerns they may have during the study period. Subjects will undergo cardiac magnetic resonance imaging (CMR) and pulmonary function tests (PFT) at baseline and then again at 12 months post enrollment. Subjects will also complete a quality of life questionnaire at baseline and 12 months. Degree of elbow contracture will be measured using a goniometer at baseline and 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles, University of Utah, University of Colorado, Denver, University of Kansas Medical Center, Vanderbilt University Medical Center

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartMar 20, 2015
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.4 years ago

Interventions

Eplerenonedrug

26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.

Spironolactonedrug

26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.