Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00555880
First received: November 8, 2007
Last updated: December 10, 2010
Last verified: June 2010

November 8, 2007
December 10, 2010
September 2004
Not Provided
Measuring the time to onset of near-syncopal symptoms (of sufficient severity that would cause the subject to ask that the tilt table be returned to the horizontal position) during a protocolized tilt table test. [ Time Frame: 10 minutes ]
Same as current
Complete list of historical versions of study NCT00555880 on ClinicalTrials.gov Archive Site
  • To evaluate the clinical benefit of midodrine by the use of the Orthostatic Hypotension Symptom Assessment and Clinical Global Impression Scales [ Time Frame: 2 days ]
  • To evaluate the safety of midodrine by assessing heart rate, blood pressure, ECG, laboratory findings and physical examination. [ Time Frame: 2 days ]
Same as current
Not Provided
Not Provided
 
Study to Assess the Benefit of Midodrine in the Treatment of Patients With Neurogenic Orthostatic Hypotension
A Multi-Center, Double-Blind, Randomized, Placebo-controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Subjects With Moderate to Severe Neurogenic Orthostatic Hypotension

The purpose of this clinical study is to evaluate the clinical effect of midodrine hydrochloride (ProAmatine®) compared to placebo in patients with orthostatic hypotension by measuring the time to onset of near syncopal symptoms and assessing several cardiovascular measurements, such as heart rate, blood pressure, and ECG, using the tilt table test.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypotension, Orthostatic
  • Drug: Midodrine hydrochloride
    one dose, 10-30mg, given orally
    Other Name: ProAmatine
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: Midodrine hydrochloride
  • Placebo Comparator: 2
    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
March 2005
Not Provided

Inclusion Criteria:

  • The male or female subjects must be 18 years of age or older and ambulatory. (Subjects must not require assistance with a walker or wheelchair to perform regular daily activities at all times.)
  • Women of childbearing potential must have a negative serum beta HCG pregnancy test at screening and baseline.
  • The subject has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathy (i.e. neurogenic orthostatic hypotension).
  • The subject manifests one of the following symptoms while standing or has a history of one of the following when not treated for orthostatic hypotension: dizziness, lightheadedness, feeling faint or feeling like they may black out.
  • The subject is willing and able to undergo the procedures required by this protocol including morning office visits, assessment completion, protocol compliance and participation in the wash-out period.
  • The subject has signed an Institutional-Review-Board approved written informed consent form prior to any study procedures taking place.

Exclusion Criteria:

  • The subject is a pregnant or lactating female.
  • The subject has pre-existing sustained supine hypertension greater than 180 mm Hg systolic and 110 mm Hg diastolic.
  • The subject is taking medications such as vasodilators, pressors, diuretics, ACE inhibitors, angiotensin receptor blockers, beta-blockers, combined alpha and beta-blockers, MAOI's, herbals or specific mixed effect medications.
  • The Principal Investigator deems any laboratory test abnormality clinical significant.
  • The subject has a diagnosis of any of the following disorders at the time of screening: pheochromocytoma; cardiac conditions including: congestive heart failure within the previous 6 months, myocardial infarction within the previous 6 months, symptomatic coronary artery disease, history of ventricular tachycardia, or uncontrolled cardiac arrhythmias; thyrotoxicosis; uncontrolled diabetes mellitus (uncontrolled defined as a HgbA1c greater than or equal to 10%); history of cerebrovascular accident, transient ischemic attack (TIA) or symptomatic carotid artery stenosis within the previous 6 months; history of coagulopathies; pulmonary hypertension; severe psychiatric disorders; renal failure (Creatinine equal to or greater than 2 times the upper limit of normal)
  • The subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of the tests and/or measurements administered in this trial, or that might increase the risk to the subject.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555880
SPD426-404
Not Provided
Not Provided
Shire
Not Provided
Principal Investigator: Richard Malamut, MD Crozer Chester Medical Center, Pennsylvania, USA
Shire
June 2010

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