Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02354352 · ClinicalTrials.gov registry record · Phase 3
Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy
A Phase 3 study of Duchenne Muscular Dystrophy, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
- 6
- Study locations
NCT02354352: Completed Phase 3 study of Duchenne Muscular Dystrophy, sponsored by Ohio State University.
NCT02354352 is a Phase 3 study of Duchenne Muscular Dystrophy that has completed, run by Ohio State University. The registered enrollment target is 52 participants, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02354352, a Phase 3 study of Duchenne Muscular Dystrophy, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
a sensitive measure of heart muscle function
Conditions Studied
Interventions
- DRUG Spironolactone
- DRUG Eplerenone
Study Locations (6)
California
- Mattel Children's Hospital and David Geffen School of Medicine at UCLA - Los Angeles
Colorado
- University of Colorado - Aurora
Kansas
- University of Kansas Medical Center - Kansas City
Ohio
- The Ohio State University Medical Center - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-03-20 |
| Est. Completion | 2018-05 |
| Phase | Phase 3 |
What the finished NCT02354352 record still lists
NCT02354352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Spironolactone is the first listed.
NCT02354352 lists 6 locations in 6 states (California, Colorado, Kansas).
Frequently Asked Questions
What is clinical trial NCT02354352 about?
NCT02354352 is a clinical study titled "Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy". 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 ran...
What is the current status of trial NCT02354352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2015-03-20. Estimated completion is 2018-05.
What conditions does trial NCT02354352 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy.
What interventions are being tested in trial NCT02354352?
The interventions under investigation include: Spironolactone (DRUG), Eplerenone (DRUG).
Who is sponsoring clinical trial NCT02354352?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02354352 being conducted?
This trial has 6 study locations across California, Colorado, Kansas, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02354352's enrollment target sits among peer trials
52 23rd of 48 higher than 26 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)
ACTIVE NOT RECRUITING · Phase 3
-
Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy
ACTIVE NOT RECRUITING · Phase 3
-
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)
COMPLETED · Phase 3
-
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
RECRUITING · Phase 1
-
AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)
RECRUITING · Phase 2
-
A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD)
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI