A Study for Patients With Neurogenic Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00046475
First received: September 30, 2002
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

We are seeking male and female patients to voluntarily take part in a clinical research study. Patients must be aged 18 or older and diagnosed with symptomatic orthostatic hypotension (low blood pressure while in the upright position) due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension). Symptoms of low blood pressure include dizziness, lightheadedness, changes in vision and generalized weakness upon standing. The main effect of the drug being studied is to increase blood pressure in the upright position so symptoms will decrease.

The purpose of this clinical study is to further assess the clinical benefit of midodrine hydrochloride (ProAmatine®), an approved treatment for orthostatic hypotension. During the course of the study, participants will receive either ProAmatine® or a placebo. Assessments will be made using questionnaires that measure symptom and activity levels. Blood pressure in the lying down and standing positions will be measured at each visit.


Condition Intervention Phase
Hypotension, Orthostatic
Drug: Midodrine Hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Assess the Clinical Benefit of Midodrine Hydrochloride in Patients With Neurogenic Orthostatic Hypotension

Resource links provided by NLM:


Further study details as provided by Shire:

Estimated Enrollment: 120
Study Start Date: January 2002
Study Completion Date: October 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The male or female patient must be 18 years of age or older and ambulatory.
  • Female patients must be: without menses for at least 12 months prior to screening; surgically sterilized (bilateral tubal ligation or hysterectomy); or practicing adequate means of birth control. Adequate means of birth control is defined as the use of prescribed birth control pills, IUD, or hormonal injections from at least one month prior to screening. Double-barrier methods and abstinence are also acceptable forms of birth control.
  • The patient has been diagnosed with symptomatic orthostatic hypotension due to Parkinson's disease, multiple system atrophy, pure autonomic failure or autonomic neuropathies (i.e. neurogenic orthostatic hypotension).
  • The patient manifests at least 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 patient 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 patient signs an Institutional-Review-Board approved written Informed Consent form prior to any study procedures taking place.

Exclusion Criteria:

  • The patient is pregnant or lactating female.
  • The patient has pre-existing sustained supine hypertension greater than 180 systolic and 110 diastolic mmHg.
  • The patient 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 clinically significant.
  • The patient 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 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 patient 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 patient.
  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: NCT00046475

Locations
United States, Alabama
North Alabama Neuroscience Research
Huntsville, Alabama, United States, 35801
United States, Florida
Dr. Harry Pepe & Associates, Inc.
Miramar, Florida, United States, 33023
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
United States, Illinois
Economou & Associates, LTD
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States
United States, Michigan
Michigan Pain and Neurological Institute
Ann Arbor, Michigan, United States
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
NY Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Medical College of Ohio
Toledo, Ohio, United States, 43614
United States, Oklahoma
COR Clinical Research, LLC
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Westmoreland Neurology Associates Inc.
Greensburg, Pennsylvania, United States, 15601
Neurological Associates of Delaware Valley
Upland, Pennsylvania, United States, 19013
United States, Texas
Diabetes & Glandular Disease Research Associates, PA
San Antonio, Texas, United States
United States, Virginia
Monarch Medical Research
Norfolk, Virginia, United States, 23502
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Shire
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00046475     History of Changes
Other Study ID Numbers: 20,762-401
Study First Received: September 30, 2002
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Orthostatic Intolerance
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Agents
Vascular Diseases
Cardiovascular Diseases
Primary Dysautonomias
Midodrine
Sympathomimetics
Autonomic 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 July 20, 2014