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: November 10, 2014

Last verified: October 2014

History of Changes

Results First Received: October 16, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Symptomatic Orthostatic Hypotension
Interventions:	Drug: Midodrine HCl 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
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 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 - (Randomized)	Placebo - (Randomized)
STARTED	33 ^[1]	34
COMPLETED	33	34
NOT COMPLETED	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

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 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
Overall Participants Analyzed [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 ]

Show Outcome Measure 1

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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:

Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01515865 History of Changes
Other Study ID Numbers:	SPD426-405 2012-005760-99 ( EudraCT Number )
Study First Received:	January 18, 2012
Results First Received:	October 16, 2014
Last Updated:	November 10, 2014

To Top