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

History of Changes

Results First Received: July 3, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Participant, Care Provider, 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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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)

	Placebo First, Then Midodrine HCl (Randomized Phase)	Midodrine HCl First, Then Placebo (Randomized Phase)
STARTED	10	10
COMPLETED	9	10
NOT COMPLETED	1	0
Not specified	1	0

Period 3: Randomized Phase (Second Intervention)

	Placebo First, Then Midodrine HCl (Randomized Phase)	Midodrine HCl First, Then Placebo (Randomized Phase)
STARTED	9	10
COMPLETED	9	10
NOT COMPLETED	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
Overall Participants Analyzed [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 ]

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Serious Adverse Events

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Other Adverse Events

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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
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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:

	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
phone: +1 866-842-5335

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

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