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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Roberts Pharmaceutical |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00004268 |
Purpose
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.
| Condition | Intervention | Phase |
|
Orthostatic Hypotension |
Drug: midodrine |
Phase II |
| MedlinePlus related topics: | Low Blood Pressure |
| Drug Information available for: | Midodrine Midodrine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2001 |
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |||||
| Mount Sinai School of Medicine | |||||
| New York, New York, United States, 10029 | |||||
| National Center for Research Resources (NCRR) |
| Roberts Pharmaceutical |
| Study Chair: | Horacio Kaufmann | Roberts Pharmaceutical |
More Information
| Study ID Numbers: | 199/11645, RLI-5894009 |
| First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004268 |
| Health Authority: | United States: Federal Government |
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