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Tilt-Table Study of the Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT01518946•Shire

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (13)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Advance Research Institute Inc

New Port Richey, Florida, United States

Analab Clinical Research Inc

Lenexa, Kansas, United States

Mayo Clinic

Rochester, Minnesota, United States

Buffalo Clinical Research Center (BCRC)

Buffalo, New York, United States

NYU Medical Centre

New York, New York, United States

Columbia University

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Kidney and Hypertension Center

Roseburg, Oregon, United States

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, United States

Key Dates

Start Date

May 14, 2012

Primary Completion Date

June 22, 2013

Completion Date

June 22, 2013

Last Updated

June 8, 2021

Enrollment

ACTUAL participants

Conditions

Orthostatic Hypotension

Interventions

Midodrine HCl

DRUG

Placebo

DRUG

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

NCT02429557

Orthostatic HypotensionPure Autonomic Failure+2 more

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RECRUITINGPHASE1

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

NCT02897063

Autonomic FailurePure Autonomic Failure+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure

POLish Registry of CArdioneuroablation and CArdioneuromodulation

The Effect of Water Carbonation on Orthostatic Tolerance

The Effect of Rehabilitation Training on Orthostatic Hypotension in Parkinson's Patients

Water and the Gastropressor Response - Tachyphylaxis