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Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

Primary Purpose

Orthostatic Hypotension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
midodrine
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring cardiovascular and respiratory diseases, disease-related problem/condition, orthostatic hypotension, quality of life, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
Roberts Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00004268
Brief Title
Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
Roberts Pharmaceutical

4. Oversight

5. Study Description

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 this treatment regimen.
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. Quality of life is assessed at weeks 3, 6, and 8.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthostatic Hypotension
Keywords
cardiovascular and respiratory diseases, disease-related problem/condition, orthostatic hypotension, quality of life, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
midodrine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann
Organizational Affiliation
Roberts Pharmaceutical
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

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