Status:

COMPLETED

Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

Lead Sponsor:

National Center for Research Resources (NCRR)

Collaborating Sponsors:

Roberts Pharmaceutical

Conditions:

Orthostatic Hypotension

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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...

Detailed Description

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. Qua...

Eligibility 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

Key Trial Info

Start Date :

April 1 2001

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT00004268

Start Date

April 1 2001

Last Update

June 24 2005

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Mount Sinai School of Medicine

New York, New York, United States, 10029

Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension | DecenTrialz