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A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00426842
First received: January 24, 2007
Last updated: August 29, 2016
Last verified: August 2016
Results First Received: September 17, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Orthostatic Hypotension
Spinal Cord Injury
Intervention: Drug: Midodrine Hydrochloride

  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
2008-2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
no subject was excluded from study participate prior to group assignment.

Reporting Groups
  Description
All Participants All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.

Participant Flow:   Overall Study
    All Participants
STARTED   11 
COMPLETED   10 
NOT COMPLETED   1 
Lost to Follow-up                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.
No text entered.

Reporting Groups
  Description
Arm 1 Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.

Baseline Measures
   Arm 1 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (9) 
Gender 
[Units: Participants]
 
Female   2 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Systolic Blood Pressure   [ Time Frame: The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position. ]


  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
A matching placebo tablet was not used and the order of testing was not randomized. The total number of subjects recruited was relatively small and extrapolation to a broader group of individuals with chronic SCI may not be appropriate.


  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: Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00426842     History of Changes
Other Study ID Numbers: 00893
VA Project #5481-06-051 ( Other Identifier: JJPVAMC IRB )
Study First Received: January 24, 2007
Results First Received: September 17, 2013
Last Updated: August 29, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration