Cardiomyopathy in DMD: Lisinopril vs. Losartan

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. Identifier: NCT01982695
Recruitment Status : Completed
First Posted : November 13, 2013
Results First Posted : March 21, 2017
Last Update Posted : March 21, 2017
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

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)
Interventions: Drug: Losartan
Drug: Lisinopril

  Participant Flow

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
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 

  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.
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Reporting Groups
Lisinopril Lisinopril
Lospartan Lisinopril
Total Total of all reporting groups

Baseline Measures
   Lisinopril   Lospartan   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
[Units: Years]
Median (Full Range)
 (10 to 21) 
 (7 to 27) 
 (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

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

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

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

Responsible Party: Jerry R. Mendell, Nationwide Children's Hospital 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