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
  Purpose

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.


Condition Intervention Phase
Hypotension, Orthostatic
Drug: Midodrine hydrochloride
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: September 2004
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: 1 Drug: Midodrine hydrochloride
one dose, 10-30mg, given orally
Other Name: ProAmatine
Placebo Comparator: 2 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555880

Locations
United States, Indiana
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States, 46805
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Minnesota VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Forest Park Neurophysiology
Saint Louis, Missouri, United States, 63139
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Raleigh Neurology Associates
Raleigh, North Carolina, United States, 27607
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, South Carolina
Absher Neurology, PA
Greenville, South Carolina, United States, 29615
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Texas
Diabetes and Glandular Disease research Associates, PA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Richard Malamut, MD Crozer Chester Medical Center, Pennsylvania, USA
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00555880     History of Changes
Other Study ID Numbers: SPD426-404
Study First Received: November 8, 2007
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Midodrine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014