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Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01518946
First received: January 18, 2012
Last updated: October 10, 2014
Last verified: July 2014
Results First Received: July 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: 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
No text entered.

Reporting Groups
  Description
Midodrine HCl (Open-label Phase) 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.
Placebo First, Then Midodrine HCl (Randomized Phase) Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
Midodrine HCl First, Then Placebo (Randomized Phase) Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.

Participant Flow for 3 periods

Period 1:   Open-label Phase
    Midodrine HCl (Open-label Phase)     Placebo First, Then Midodrine HCl (Randomized Phase)     Midodrine HCl First, Then Placebo (Randomized Phase)  
STARTED     24     0     0  
COMPLETED     20     0     0  
NOT COMPLETED     4     0     0  
Not specified                 4                 0                 0  

Period 2:   Randomized Phase (First Intervention)
    Midodrine HCl (Open-label Phase)     Placebo First, Then Midodrine HCl (Randomized Phase)     Midodrine HCl First, Then Placebo (Randomized Phase)  
STARTED     0     10     10  
COMPLETED     0     9     10  
NOT COMPLETED     0     1     0  
Not specified                 0                 1                 0  

Period 3:   Randomized Phase (Second Intervention)
    Midodrine HCl (Open-label Phase)     Placebo First, Then Midodrine HCl (Randomized Phase)     Midodrine HCl First, Then Placebo (Randomized Phase)  
STARTED     0     9     10  
COMPLETED     0     9     10  
NOT COMPLETED     0     0     0  



  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.
Randomized Safety Analysis Set defined as all subjects who received at least 1 dose of randomized investigational product.

Reporting Groups
  Description
Placebo First, Then Midodrine HCl (Randomized Phase) Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
Midodrine HCl First, Then Placebo (Randomized Phase) Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
Total Total of all reporting groups

Baseline Measures
    Placebo First, Then Midodrine HCl (Randomized Phase)     Midodrine HCl First, Then Placebo (Randomized Phase)     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Mean ± Standard Deviation
  48.0  ± 19.52     42.1  ± 18.64     45.1  ± 18.82  
Age, Customized  
[units: participants]
     
18 to 65 years, inclusive     8     8     16  
>= 66 years     2     2     4  
Gender  
[units: participants]
     
Female     8     10     18  
Male     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures

1.  Primary:   Time to Onset of Syncope/Near Syncope While on Tilt Table   [ Time Frame: 1 hour post-dose ]


  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
phone: +1 866-842-5335


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01518946     History of Changes
Other Study ID Numbers: SPD426-406
Study First Received: January 18, 2012
Results First Received: July 3, 2014
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration