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Home > "A" Clinical Trials Conditions > A Study for Patients with Neurogenic Orthostatic Hypotension  A Study for Patients with Neurogenic Orthostatic Hypotension
A Study for Patients with Neurogenic Orthostatic Hypotension
For Condition: Hypotension, Orthostatic
Status: Recruiting
Sponsor(s): Shire Pharmaceutical Development ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 120
Location and Contact Information:
Johns Hopkins Hospital *Recruiting*
Baltimore, Maryland,
United States
Recruiting Janice Stack 410-614-4576
Monarch Medical Research *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting David Vendt 757-466-7263
Economou & Associates, LTD *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Study Coordinator 312-829-3532
NY Presbyterian Hospital *Recruiting*
New York City, New York, 10032
United States
Recruiting Daniel Bloomfield 212-305-6634
Medical College of Ohio *Recruiting*
Toledo, Ohio, 43614
United States
Recruiting Dyan Serna 419-383-3697
Dr. Harry Pepe & Associates, Inc. *Recruiting*
Miramar, Florida, 33023
United States
Recruiting Donna Regula 954-981-4811
West Virginia University *Recruiting*
Morgantown, West Virginia, 26506
United States
Recruiting Connie Bolyard 304-293-4117
Diabetes & Glandular Disease Research Associates, PA *Recruiting*
San Antonio, Texas,
United States
Recruiting Laurel Greg 210-615-5565
Suncoast Neuroscience Associates, Inc. *Recruiting*
St. Petersburg, Florida,
United States
Recruiting Suzanne Lash 727-824-7135
North Alabama Neuroscience Research *Recruiting*
Huntsville, Alabama, 35801
United States
Recruiting George Morgan 256-533-3552
COR Clinical Research, LLC *Recruiting*
Oklahoma City, Oklahoma, 73103
United States
Recruiting Clinton Corder 405-272-8481
Neurological Associates of Delaware Valley *Recruiting*
Upland, Pennsylvania, 19013
United States
Recruiting Barbara Dick 610-876-4800
Dartmouth Hitchcock Medical Center *Recruiting*
Lebanon, New Hampshire, 03756
United States
Recruiting Pauline LeBlanc 603-650-4165
Westmoreland Neurology Associates Inc. *Recruiting*
Greensburg, Pennsylvania, 15601
United States
Recruiting Norma Skillings 724-835-1921
Michigan Pain and Neurological Institute *Recruiting*
Ann Arbor, Michigan,
United States
Recruiting Study Coordinator 734-677-6000
Additional Information:
Study ID Numbers: 20,762-401;
Study Start Date: January 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046475
Other Hypotension, Orthostatic Studies:
1. A Study for Patients with Neurogenic Orthostatic Hypotension
2. A Phase IV Study in Subjects with Neurogenic Orthostatic Hypotension
Related Studies:
Other Hypotension, Orthostatic Clinical Trials
Other Florida Clinical Trials
Other St. Petersburg Clinical Trials
A Study for Patients with Neurogenic Orthostatic Hypotension
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