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Cardiomyopathy in DMD: Lisinopril vs. Losartan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01982695
First Posted: November 13, 2013
Last Update Posted: March 21, 2017
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.
Collaborators:
Boston Children’s Hospital
University of California, Davis
Unverisity of Kansas Medical Center
University of Minnesota - Clinical and Translational Science Institute
St. Louis Children's Hospital
Information provided by (Responsible Party):
Jerry R. Mendell, Nationwide Children's Hospital
Results First Submitted: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Duchenne Muscular Dystrophy (DMD)
Cardiomyopathy
Interventions: Drug: Losartan
Drug: Lisinopril

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lisinopril Approximately 0.07 mg/kg/day in oral capsules
Losartan Approximately 0.7 mg/kg/day in oral capsules

Participant Flow:   Overall Study
    Lisinopril   Losartan
STARTED   12   11 
COMPLETED   12   10 
NOT COMPLETED   0   1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Lisinopril Lisinopril
Lospartan Lisinopril
Total Total of all reporting groups

Baseline Measures
   Lisinopril   Lospartan   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
Age 
[Units: Years]
Median (Full Range)
 12.5 
 (10 to 21) 
 15.5 
 (7 to 27) 
 14 
 (7 to 27) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      12 100.0%      11 100.0%      23 100.0% 
Ejection Fraction 
[Units: Percentage of blood leaving the heart]
Mean (Standard Deviation)
 47.5  (6.25)   47.7  (5.49)   47.6  (5.77) 


  Outcome Measures

1.  Primary:   Cardiac Ejection Fraction as Measured by Echocardiogram   [ Time Frame: 12 month visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Jerry R. Mendell
Organization: Nationwide Children's Hopsital
phone: (614) 722-5615
e-mail: Jerry.Mendell@NationwideChildrens.org


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jerry R. Mendell, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01982695     History of Changes
Other Study ID Numbers: IRB12-00149
First Submitted: October 29, 2013
First Posted: November 13, 2013
Results First Submitted: August 14, 2015
Results First Posted: March 21, 2017
Last Update Posted: March 21, 2017