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Trial record 31 of 1002 for:    BMD

Eplerenone for Subclinical Cardiomyopathy in Duchenne Muscular Dystrophy (E-SCAR DMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01521546
Recruitment Status : Completed
First Posted : January 30, 2012
Results First Posted : May 27, 2015
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
Ballou Skies
Information provided by (Responsible Party):
Subha Raman, Ohio State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Duchenne Muscular Dystrophy
Interventions Drug: eplerenone
Drug: placebo
Enrollment 42
Recruitment Details  
Pre-assignment Details Enrollment was required prior to assignment.
Arm/Group Title Placebo Eplerenone
Hide Arm/Group Description

placebo

placebo: one tablet by mouth daily for 12 months

active study drug

eplerenone: 25mg tablet, once daily by mouth for 12 months

Period Title: Overall Study
Started 22 20
Completed 20 20
Not Completed 2 0
Arm/Group Title Eplerenone Placebo Total
Hide Arm/Group Description

active study drug

eplerenone: 25mg tablet, once daily by mouth for 12 months

placebo

placebo: one tablet by mouth daily for 12 months

Total of all reporting groups
Overall Number of Baseline Participants 20 22 42
Hide Baseline Analysis Population Description
Males with Duchenne Muscular Dystrophy
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Age Number Analyzed 20 participants 22 participants 42 participants
14.5
(12.0 to 18.5)
15.0
(11.0 to 19.0)
15.0
(11.75 to 19.0)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 22 participants 42 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
20
 100.0%
22
 100.0%
42
 100.0%
[1]
Measure Description: The study was approved for 42 participants and 42 participants were enrolled.
1.Primary Outcome
Title 12-month Change in Myocardial Strain
Hide Description a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.
Time Frame baseline and 12 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Eplerenone
Hide Arm/Group Description:
placebo: one tablet by mouth daily for 12 months
eplerenone one tablet by mouth daily for 12 months
Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: percent change in heart dimension
2.2
(1.3 to 3.1)
1.0
(0.3 to 2.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Eplerenone
Hide Arm/Group Description placebo one tablet daily for 12 months eplerenone one tablet daily for 12 months
All-Cause Mortality
Placebo Eplerenone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Eplerenone
Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   0/20 (0.00%) 
Vascular disorders     
death due to fat embolism  1/22 (4.55%)  0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Eplerenone
Affected / at Risk (%) Affected / at Risk (%)
Total   2/22 (9.09%)   1/20 (5.00%) 
Nervous system disorders     
headache coincident with seasonal allergies  0/22 (0.00%)  1/20 (5.00%) 
Psychiatric disorders     
anxiety  1/22 (4.55%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders     
flushing  1/22 (4.55%)  0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Subha V. Raman, MD
Organization: The Ohio State University
Phone: (614)293-8963
EMail: raman.1@osu.edu
Layout table for additonal information
Responsible Party: Subha Raman, Ohio State University
ClinicalTrials.gov Identifier: NCT01521546     History of Changes
Other Study ID Numbers: 2011H0251
First Submitted: January 26, 2012
First Posted: January 30, 2012
Results First Submitted: April 21, 2015
Results First Posted: May 27, 2015
Last Update Posted: November 8, 2016