Safety and Efficacy of L-NAME and Midodrine to Increase MAP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00835224
First received: January 30, 2009
Last updated: March 21, 2014
Last verified: March 2014
Results First Received: September 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Orthostatic Hypotension
Spinal Cord Injury
Interventions: Drug: L-NAME
Drug: Midodrine
Drug: Placebo

  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
34 subjects were consented 24 completed testing. Subjects were recruited through the Center of Excellence for the Medical Consequences of Spinal Cord Injury (SCI) from June 2010 to August of 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility criteria were covered by the study coordinator prior to enrollment.

Reporting Groups
  Description
All Participants All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.

Participant Flow:   Overall Study
    All Participants  
STARTED     34  
COMPLETED     24  
NOT COMPLETED     10  



  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.
30 subjects were anticipated but 34 were enrolled following an IRB approval to expand the n. Increased recruitment was due to a number of subjects withdrawing from participation for various reasons listed below.

Reporting Groups
  Description
All Participants All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 12  
Gender  
[units: participants]
 
Female     7  
Male     27  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures

1.  Primary:   Blood Pressure   [ Time Frame: Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration ]


  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
Study population was relatively small and were not blinded to the interventions.


  More Information
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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: Dr. Jill M. Wecht
Organization: James J Peters VAMC
phone: 718 584-9000 ext 3122
e-mail: jm.wecht@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00835224     History of Changes
Other Study ID Numbers: A6161-W, VA Project #5481-08-017
Study First Received: January 30, 2009
Results First Received: September 12, 2013
Last Updated: March 21, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration