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

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ClinicalTrials.gov Identifier: NCT00426842
Recruitment Status : Completed
First Posted : January 25, 2007
Results First Posted : May 12, 2015
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Jill M. Wecht, Ed.D., James J. Peters Veterans Affairs Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Orthostatic Hypotension
Spinal Cord Injury
Intervention Drug: Midodrine Hydrochloride
Enrollment 11
Recruitment Details 2008-2010
Pre-assignment Details no subject was excluded from study participate prior to group assignment.
Arm/Group Title All Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Arm 1
Hide Arm/Group Description Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
42  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title Systolic Blood Pressure
Hide Description brachial artery systolic blood pressure (mmHg)
Time Frame The difference between the average supine systolic blood pressure and the average systolic blood pressure at 45 degree head-up tilt position.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No-drug Midodrine 5 mg Midodrine 10 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 11 10 10
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline Blood Pressure 98  (5) 97  (5) 102  (12)
Head-up Tilt Blood Pressure 87  (15) 96  (19) 109  (22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/11 (0.00%) 
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.
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: 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 )
First Submitted: January 24, 2007
First Posted: January 25, 2007
Results First Submitted: September 17, 2013
Results First Posted: May 12, 2015
Last Update Posted: October 10, 2016