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: July 3, 2014
Last verified: July 2014

January 18, 2012
July 3, 2014
May 2012
June 2013   (final data collection date for primary outcome measure)
Time to Onset of Syncope/Near Syncope While on Tilt Table [ Time Frame: 1 hour post-dose ] [ Designated as safety issue: No ]
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.
Time to onset of syncope/near syncope while on tilt table [ Time Frame: 1 hour post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01518946 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Orthostatic Hypotension
  • Drug: Midodrine HCl
    dose at the subject's current dose level
    Other Name: ProAmatine®
  • Drug: Placebo
    single dose of matching placebo
  • Active Comparator: Midodrine HCl
    Intervention: Drug: Midodrine HCl
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01518946
SPD426-406
Yes
Shire
Shire
Not Provided
Not Provided
Shire
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP