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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 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.

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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.

Conditions Studied

Duchenne Muscular Dystrophy

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

FieldValue
Enrollment Target 52 participants
Start Date 2015-03-20
Est. Completion 2018-05
Phase Phase 3

Sponsor

Ohio State University

552 total trials

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What the Registry Record Tells You About NCT02354352

The ClinicalTrials.gov registry entry for NCT02354352 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 411-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (87% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.