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Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension



Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

For Condition: Orthostatic Hypotension
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Roberts Pharmaceutical
Synopsis: OBJECTIVES: I. Study further the safety and efficacy of the alpha-receptor agonist midodrine in patients with neurogenic orthostatic hypotension. II. Assess the quality of life in these patients with this treatment regimen.
Details: PROTOCOL OUTLINE: This is a partially randomized, multicenter study. Patients receive oral midodrine three times a day during weeks 1 and 3-5, then either oral midodrine or placebo for weeks 6-8. Quality of life is assessed at weeks 3, 6, and 8.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Orthostatic hypotension due to autonomic nervous system failure, i.e.: Fall in systolic blood pressure (supine to standing) of at least 15 mm Hg AND Symptoms of dizziness, lightheadedness, unsteadiness with a severity of 4.5 or less on a 10 point scale in 2 of 3 evaluations over a 3 day period --Prior/Concurrent Therapy-- No concurrent sympathomimetics or alpha-receptor agonists or antagonists No concurrent drug with significant smooth muscle relaxant or constrictive properties e.g., calcium channel blockers At least 30 days since other prior investigational agents --Patient Characteristics-- Hepatic: No coagulopathy Renal: No acute nephritis or chronic renal failure Cardiovascular: No sustained supine hypertension greater than 180/110 mm Hg No congestive heart failure No myocardial infarction within the last 6 months No uncontrolled arrhythmia (ventricular tachycardia or second or third degree heart block not treated with pacemaker) No unstable angina pectoris No history of cerebral vascular accident Other: No pheochromocytoma No thyrotoxicosis No seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
Total Enrollment: 300

Location and Contact Information:

Overall Study Official:
HoracioKaufmann,  Study Chair,  Roberts Pharmaceutical

Mount Sinai School of Medicine
New York City,  New York,  10029
United States
 


Additional Information:
Study ID Numbers:  199/11645;  RLI-5894009
Study Start Date: April 2001
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004268

Other Orthostatic Hypotension Studies:
1. Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

2. Droxidopa in Treating Patients With Neurogenic Hypotension

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