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
1 other identifier
interventional
24
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2012
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 26, 2012
CompletedStudy Start
First participant enrolled
May 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2013
CompletedResults Posted
Study results publicly available
July 31, 2014
CompletedJune 8, 2021
May 1, 2021
1.1 years
January 18, 2012
July 3, 2014
May 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Midodrine HCl
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female subjects must be 18 years of age or older and ambulatory.
- Females of child-bearing potential (FOCP) must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test.
- 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.
- 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.
You may not qualify if:
- The subject is a pregnant or lactating female.
- 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.
- 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.
- The Principal Investigator deems any clinical laboratory test (at the Screening Visit) abnormality to be clinically significant
- 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).
- 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.
- 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.
- Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
- Prior enrollment failure or randomization in this study.
- History of alcohol abuse or other substance abuse within the last year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (13)
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Advance Research Institute Inc
New Port Richey, Florida, 34653, United States
Analab Clinical Research Inc
Lenexa, Kansas, 66219, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Buffalo Clinical Research Center (BCRC)
Buffalo, New York, 14202, United States
NYU Medical Centre
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kidney and Hypertension Center
Roseburg, Oregon, 97471, United States
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920, United States
The Heartbeat Clinic, PA
McKinney, Texas, 75069, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215, United States
Related 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: 10.1007/s10286-016-0363-9. Epub 2016 Jul 2.
PMID: 27372462RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 26, 2012
Study Start
May 14, 2012
Primary Completion
June 22, 2013
Study Completion
June 22, 2013
Last Updated
June 8, 2021
Results First Posted
July 31, 2014
Record last verified: 2021-05