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Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01515865
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : October 22, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Symptomatic Orthostatic Hypotension
Interventions Drug: Midodrine HCl
Drug: Placebo
Enrollment 67
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Midodrine HCl - (Open-label) Midodrine HCl - (Randomized) Placebo - (Randomized)
Hide Arm/Group Description 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. On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose). On Day 16 subjects received matching placebo.
Period Title: Part A (Open-label)
Started 98 0 0
Completed 95 0 0
Not Completed 3 0 0
Reason Not Completed
Other             3             0             0
Period Title: Part B (Open-label)
Started 71 [1] 0 0
Completed 69 0 0
Not Completed 2 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Other             1             0             0
[1]
Twenty-four subjects from Part A did not meet the criteria required to be enrolled into Part B.
Period Title: Part C (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.
Arm/Group Title Enrolled Population
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 98
Hide Baseline Analysis Population Description
The Enrolled Population consisted of all subjects who participated in Part A baseline procedures starting at Day -1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants
45.5  (17.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants
Female
76
  77.6%
Male
22
  22.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants
United States 90
Slovakia 3
Poland 5
1.Primary Outcome
Title Percent of Subjects Who Failed to Maintain a Response
Hide Description

Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:

  1. The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.
  2. There was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness.
Time Frame 30 minutes post-dose on Day 16
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.
Arm/Group Title Midodrine HCl Placebo
Hide Arm/Group Description:
Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
Overall Number of Participants Analyzed 33 34
Measure Type: Number
Unit of Measure: percentage of participants
30.3 44.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Midodrine HCl, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3145
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.8
Confidence Interval (2-Sided) 95%
-37.6 to 9.8
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Midodrine HCl - Open-label (Part A) Midodrine HCl - Open-label (Part B) Midodrine HCl - Randomized (Part C) Placebo - Randomized (Part C)
Hide Arm/Group Description dose at the subjects current dose level open-label study-supplied (Part B) dose at subjects current dose level over-encapsulated randomized dose (Part C) at subjects current dose level over-encapsulated randomized matching placebo
All-Cause Mortality
Midodrine HCl - Open-label (Part A) Midodrine HCl - Open-label (Part B) Midodrine HCl - Randomized (Part C) Placebo - Randomized (Part C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Midodrine HCl - Open-label (Part A) Midodrine HCl - Open-label (Part B) Midodrine HCl - Randomized (Part C) Placebo - Randomized (Part C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/98 (0.00%)      0/71 (0.00%)      0/33 (0.00%)      0/34 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Midodrine HCl - Open-label (Part A) Midodrine HCl - Open-label (Part B) Midodrine HCl - Randomized (Part C) Placebo - Randomized (Part C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/98 (5.10%)      2/71 (2.82%)      0/33 (0.00%)      0/34 (0.00%)    
Nervous system disorders         
Headache  5/98 (5.10%)  5 2/71 (2.82%)  2 0/33 (0.00%)  0 0/34 (0.00%)  0
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01515865    
Other Study ID Numbers: SPD426-405
2012-005760-99 ( EudraCT Number )
First Submitted: January 18, 2012
First Posted: January 24, 2012
Results First Submitted: October 16, 2014
Results First Posted: October 22, 2014
Last Update Posted: November 21, 2014