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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ballou Skies
Information provided by (Responsible Party):
Subha Raman, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01521546
First received: January 26, 2012
Last updated: June 26, 2015
Last verified: June 2015
Results First Received: April 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Duchenne Muscular Dystrophy
Interventions: Drug: eplerenone
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment was required prior to assignment.

Reporting Groups
  Description
Placebo

placebo

placebo: one tablet by mouth daily for 12 months

Eplerenone

active study drug

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


Participant Flow:   Overall Study
    Placebo     Eplerenone  
STARTED     22     20  
COMPLETED     20     20  
NOT COMPLETED     2     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Males with Duchenne Muscular Dystrophy

Reporting Groups
  Description
Eplerenone

active study drug

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

Placebo

placebo

placebo: one tablet by mouth daily for 12 months

Total Total of all reporting groups

Baseline Measures
    Eplerenone     Placebo     Total  
Number of Participants  
[units: participants]
  20     22     42  
Age  
[units: years]
Median (Inter-Quartile Range)
     
Age     14.5  
  (12.0 to 18.5)  
  15.0  
  (11.0 to 19.0)  
  15.0  
  (11.75 to 19.0)  
Gender [1]
[units: participants]
     
Female     0     0     0  
Male     20     22     42  
[1] The study was approved for 42 participants and 42 participants were enrolled.



  Outcome Measures

1.  Primary:   12-month Change in Myocardial Strain   [ Time Frame: baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Subha V. Raman, MD
Organization: The Ohio State University
phone: (614)293-8963
e-mail: raman.1@osu.edu


No publications provided by Ohio State University

Publications automatically indexed to this study:

Responsible Party: Subha Raman, The Ohio State University
ClinicalTrials.gov Identifier: NCT01521546     History of Changes
Other Study ID Numbers: 2011H0251
Study First Received: January 26, 2012
Results First Received: April 21, 2015
Last Updated: June 26, 2015
Health Authority: United States: Institutional Review Board