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Trial record 3 of 3 for:    "Quadriplegia" | "Adrenergic alpha-Agonists"

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

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ClinicalTrials.gov Identifier: NCT00835224
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Orthostatic Hypotension
Spinal Cord Injury
Interventions Drug: L-NAME
Drug: Midodrine
Drug: Placebo
Enrollment 34
Recruitment Details 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 Eligibility criteria were covered by the study coordinator prior to enrollment.
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 34
Completed 24
Not Completed 10
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
40  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
7
  20.6%
Male
27
  79.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Blood Pressure
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1A Arm 1B Arm 2A Arm 2B Arm 3A Arm 3B
Hide Arm/Group Description:
Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
Overall Number of Participants Analyzed 15 10 15 10 15 10
Mean (Standard Deviation)
Unit of Measure: mmHg
120  (17) 112  (10) 117  (19) 109  (5) 96  (12) 109  (6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1A Arm 1B Arm 2A Arm 2B Arm 3A Arm 3B
Hide Arm/Group Description Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME) Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine. Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
All-Cause Mortality
Arm 1A Arm 1B Arm 2A Arm 2B Arm 3A Arm 3B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1A Arm 1B Arm 2A Arm 2B Arm 3A Arm 3B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/9 (0.00%)   0/15 (0.00%)   0/9 (0.00%)   0/15 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1A Arm 1B Arm 2A Arm 2B Arm 3A Arm 3B
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/9 (0.00%)   0/15 (0.00%)   0/9 (0.00%)   0/15 (0.00%)   0/9 (0.00%) 
Study population was relatively small and were not blinded to the interventions.
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: Dr. Jill M. Wecht
Organization: James J Peters VAMC
Phone: 718 584-9000 ext 3122
EMail: jm.wecht@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00835224     History of Changes
Other Study ID Numbers: A6161-W
VA Project #5481-08-017 ( Other Identifier: JJP VAMC RR&D )
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: September 12, 2013
Results First Posted: April 23, 2014
Last Update Posted: April 23, 2014