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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Roberts Pharmaceutical |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004268 |
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 |
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Orthostatic Hypotension |
Drug: midodrine |
Phase II |
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.
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
Study ID Numbers: | 199/11645, RLI-5894009 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004268 History of Changes |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases disease-related problem/condition orthostatic hypotension quality of life rare disease |
Hypotension Neurotransmitter Agents Hypotension, Orthostatic Adrenergic alpha-Agonists Adrenergic Agents Respiration Disorders Rare Diseases Vascular Diseases |
Quality of Life Cardiovascular Agents Adrenergic Agonists Vasoconstrictor Agents Midodrine Postural Hypotension Peripheral Nervous System Agents |
Hypotension Neurotransmitter Agents Hypotension, Orthostatic Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Physiological Effects of Drugs Vascular Diseases |
Cardiovascular Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Midodrine Cardiovascular Diseases Peripheral Nervous System Agents |