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

May 16, 2021 updated by: Shire

A Phase 4, Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Clinical Benefit of Midodrine Hydrochloride in Male and Female Subjects With Symptomatic Orthostatic Hypotension

The purpose of this study is to determine whether midodrine works against the symptoms of orthostatic hypotension caused by being on a tilt table.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 4 overnight stays.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • New Port Richey, Florida, United States, 34653
        • Advance Research Institute Inc
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Analab Clinical Research Inc
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Buffalo, New York, United States, 14202
        • Buffalo Clinical Research Center (BCRC)
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10016
        • NYU Medical Centre
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Roseburg, Oregon, United States, 97471
        • Kidney and Hypertension Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center For Clinical Research - Knoxville
    • Texas
      • McKinney, Texas, United States, 75069
        • The Heartbeat Clinic, PA
    • Utah
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects must be 18 years of age or older and ambulatory.
  2. Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.
  3. A documented history of severe Symptomatic Orthostatic Hypotension (SOH) that, in the judgment of the treating physician, has required treatment with midodrine HCl , and has been at a stable dose for at least 3 months.
  4. The subject has manifested at least 1 of the following symptoms while standing or had a medical history of 1 of the following when not treated for orthostatic hypotension (OH): dizziness, lightheadedness, feeling faint, or feeling like they might black out.

Exclusion Criteria:

  1. The subject is a pregnant or lactating female.
  2. The subject has pre-existing sustained supine hypertension greater than 180mmHg systolic and 110mmHg diastolic BP or had these measurements at the Screening Visit. Sustained is defined as persistently greater at 2 separate measurements at least 5 minutes apart with the subject supine and at rest for the 5 minutes.
  3. Subjects taking concomitant medications of interest are excluded unless those medications are reviewed and discussed with the Medical Monitor or Study Physician and documented prior to enrolling the subject. If agreement is reached between the Investigator and Sponsor for the subject to continue in the study, all allowed medications should be maintained at a constant dose throughout the study.
  4. The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant
  5. The subject has participated in other studies of investigational drugs or devices within 30 days prior to enrollment in this study (other than Study SPD426-406).
  6. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  7. The subject has a concurrent chronic or acute illness, disability, or other condition (including significant unexpected laboratory or electrocardiogram [ECG] findings) that might confound the results of the tests and/or measurements administered in this study, or that might have increased the risk to the subject.
  8. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
  9. Prior enrollment failure or randomization in this study.
  10. History of alcohol abuse or other substance abuse within the last year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
single dose of matching placebo
ACTIVE_COMPARATOR: Midodrine HCl
Drug: Midodrine HCl
dose at the subject's current dose level
Other Names:
  • ProAmatine®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Onset of Syncope/Near Syncope While on Tilt Table
Time Frame: 1 hour post-dose
After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.
1 hour post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2012

Primary Completion (ACTUAL)

June 22, 2013

Study Completion (ACTUAL)

June 22, 2013

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (ESTIMATE)

January 26, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD426-406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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