Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00555880
First received: November 8, 2007
Last updated: May 5, 2015
Last verified: June 2010
Results First Received: April 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypotension, Orthostatic
Interventions: Drug: Midodrine hydrochloride
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Midodrine/Placebo Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
Placebo/Midodrine Participants received Placebo followed by a single oral dose of Midodrine HCl the next day

Participant Flow for 3 periods

Period 1:   Treatment Period 1 (1 Day)
    Midodrine/Placebo     Placebo/Midodrine  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  

Period 2:   Washout (1 Day)
    Midodrine/Placebo     Placebo/Midodrine  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2 (1 Day)
    Midodrine/Placebo     Placebo/Midodrine  
STARTED     13     11  
COMPLETED     13     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide 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.
The Safety and Full Analysis Set (FAS) populations, defined as all participants who received at least one dose of investigational product (Safety) and all participants who were randomized, received at least one dose of investigational product, and had at least one measurement of the time to near syncope during a tilt table test (FAS).

Reporting Groups
  Description
Midodrine/Placebo Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
Placebo/Midodrine Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
Total Total of all reporting groups

Baseline Measures
    Midodrine/Placebo     Placebo/Midodrine     Total  
Number of Participants  
[units: participants]
  13     11     24  
Age  
[units: years]
Mean (Standard Deviation)
  59.4  (17.84)     60.8  (12.91)     60.0  (15.46)  
Gender  
[units: participants]
     
Female     7     5     12  
Male     6     6     12  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     13     11     24  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     1     3  
White     11     10     21  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Onset of Near-syncopal Symptoms During Tilt Table Testing   [ Time Frame: 1 hour post-dose ]

2.  Primary:   Time to Onset of Near-syncopal Symptoms During Tilt Table Testing Analysis #2   [ Time Frame: 1 hour post-dose ]

3.  Primary:   Time to Onset of Near-syncopal Symptoms During Tilt Table Testing-Re-analysis With The Koch Procedure   [ Time Frame: 1 hour post-dose ]

4.  Secondary:   Time to Onset of Near-syncopal Symptoms in The Per-protocol Population   [ Time Frame: 1 hour post-dose ]

5.  Secondary:   Time to Onset of Near-syncopal Symptoms in The Per-protocol Population Analysis #2   [ Time Frame: 1 hour post-dose ]

6.  Secondary:   Time to Near-syncopal Symptoms at Treatment Visit 1   [ Time Frame: 1 hour post-dose ]

7.  Secondary:   Duration of The Effect of Treatment at 3 Hours Post-dose   [ Time Frame: 1 and 3 hours post-dose ]

8.  Secondary:   Total Score of the Orthostatic Hypotension Symptom Assessment (OHSA)   [ Time Frame: Approximately 1 hour post-dose ]

9.  Secondary:   Scores for 6 Items of The OHSA   [ Time Frame: Approximately 1 hour post-dose ]

10.  Secondary:   Number of Participants With Improvement of Clinician Clinician's Global Impression- Improvement (CGI-I) Scores After Tilt Table Test   [ Time Frame: 1 and 3 hours post-dose ]

11.  Secondary:   Number of Participants With Improvement of Patient CGI-I Scores After Tilt Table Test   [ Time Frame: 1 and 3 hours post-dose ]

12.  Secondary:   Final Blood Pressure During Tilt Table Testing   [ Time Frame: 1 hour post-dose ]

13.  Secondary:   Systolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2   [ Time Frame: 1 and 3 hours post-dose ]

14.  Secondary:   Diastolic Blood Pressure at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2   [ Time Frame: 1 and 3 hours post-dose ]

15.  Secondary:   Heart Rate at 1 Minute and 10 Minutes Into The Tilt Table Test Conducted 1 and 3 Hours Post-dose at Treatment Visit 2   [ Time Frame: 1 and 3 hours post-dose ]

16.  Secondary:   Number of Participants With Shifts in Reference to Normal Range For Hematology Analytes at Discharge   [ Time Frame: Baseline to discharge ]

17.  Secondary:   Number of Participants With Shifts in Reference to Normal Range For Clinical Chemistry at Discharge   [ Time Frame: Baseline to discharge ]

18.  Secondary:   Number of Participants With Shifts in Reference to Normal Range For Urinalysis at Discharge   [ Time Frame: Baseline to discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire
phone: +1 866 842 5335


No publications provided


ClinicalTrials.gov Identifier: NCT00555880     History of Changes
Other Study ID Numbers: SPD426-404
Study First Received: November 8, 2007
Results First Received: April 13, 2015
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration