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

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518946
• Other study ID #: SPD426-406
• Status: Completed
• Phase: Phase 4
• Start date: May 14, 2012
• Est. completion date: June 22, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 22, 2013
• Est. primary completion date: June 22, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Drug:
• Midodrine HCl
dose at the subject's current dose level
• Placebo
single dose of matching placebo

Locations

Country	Name	City	State
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	Buffalo Clinical Research Center (BCRC)	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	New Orleans Center for Clinical Research - Knoxville	Knoxville	Tennessee
United States	Analab Clinical Research Inc	Lenexa	Kansas
United States	The Heartbeat Clinic, PA	McKinney	Texas
United States	Aurora Cardiovascular Services	Milwaukee	Wisconsin
United States	Advance Research Institute Inc	New Port Richey	Florida
United States	Columbia University	New York	New York
United States	NYU Medical Centre	New York	New York
United States	Aspen Clinical Research	Orem	Utah
United States	Mayo Clinic	Rochester	Minnesota
United States	Kidney and Hypertension Center	Roseburg	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith W, Wan H, Much D, Robinson AG, Martin P. Clinical benefit of midodrine hydrochloride in symptomatic orthostatic hypotension: a phase 4, double-blind, placebo-controlled, randomized, tilt-table study. Clin Auton Res. 2016 Aug;26(4):269-77. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Onset of Syncope/Near Syncope While on Tilt Table	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