Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01515865
First received: January 18, 2012
Last updated: October 16, 2014
Last verified: October 2014
Results First Received: October 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Symptomatic Orthostatic Hypotension
Interventions: Drug: Midodrine HCl
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects received the dose and frequency of Midodrine HCl that they had been receiving during their non-study treatment prior to enrolling in this study.

Reporting Groups
  Description
Midodrine HCl - (Open-label) On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
Midodrine HCl - (Randomized) On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
Placebo - (Randomized) On Day 16 subjects were received matching placebo.

Participant Flow for 3 periods

Period 1:   Part A (Open-label)
    Midodrine HCl - (Open-label)     Midodrine HCl - (Randomized)     Placebo - (Randomized)  
STARTED     98     0     0  
COMPLETED     95     0     0  
NOT COMPLETED     3     0     0  
Not Specified                 3                 0                 0  

Period 2:   Part B (Open-label)
    Midodrine HCl - (Open-label)     Midodrine HCl - (Randomized)     Placebo - (Randomized)  
STARTED     71 [1]   0     0  
COMPLETED     69     0     0  
NOT COMPLETED     2     0     0  
Withdrawal by Subject                 1                 0                 0  
Not Specified                 1                 0                 0  
[1] Twenty-four subjects from Part A did not meet the criteria required to be enrolled into Part B.

Period 3:   Part C (Randomized)
    Midodrine HCl - (Open-label)     Midodrine HCl - (Randomized)     Placebo - (Randomized)  
STARTED     0     33 [1]   34  
COMPLETED     0     33     34  
NOT COMPLETED     0     0     0  
[1] A total of two subjects from Part B did not meet the criteria required to be enrolled into Part C.



  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.
The Enrolled Population consisted of all subjects who participated in Part A baseline procedures starting at Day -1.

Reporting Groups
  Description
Enrolled Population No text entered.

Baseline Measures
    Enrolled Population  
Number of Participants  
[units: participants]
  98  
Age  
[units: years]
Mean ± Standard Deviation
  45.5  ± 17.45  
Gender  
[units: participants]
 
Female     76  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     90  
Slovakia     3  
Poland     5  



  Outcome Measures

1.  Primary:   Percent of Subjects Who Failed to Maintain a Response   [ Time Frame: 30 minutes post-dose on Day 16 ]


  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
No text entered.


  More Information
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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 Development LLC
phone: +1 866 842 5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01515865     History of Changes
Other Study ID Numbers: SPD426-405, 2012-005760-99
Study First Received: January 18, 2012
Results First Received: October 16, 2014
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration