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Phase II Study of Midodrine for Neurogenic Orthostatic Hypotension

This study has been completed.

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:   300
Study Start Date:   April 2001

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004268

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

Sponsors and Collaborators

Investigators
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

Keywords provided by National Center for Research Resources (NCRR):
cardiovascular and respiratory diseases  
disease-related problem/condition  
orthostatic hypotension  
quality of life  
rare disease  

Study placed in the following topic categories:
Hypotension
Postural hypotension
Hypotension, Orthostatic
Respiration Disorders
Midodrine
Vascular Diseases
Rare Diseases
Quality of Life

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2008




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