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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00004478




Registration number
NCT00004478
Ethics application status
Date submitted
18/10/1999
Date registered
19/10/1999
Date last updated
18/09/2008

Titles & IDs
Public title
Droxidopa in Treating Patients With Neurogenic Hypotension
Scientific title
Study of Droxidopa in Patients With Neurologic Hypotension
Secondary ID [1] 0 0
MTS-GCO-98-243-3-NE
Secondary ID [2] 0 0
199/14180
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shy-Drager Syndrome 0 0
Orthostatic Hypotension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Neurological 0 0 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - droxidopa

Treatment: Drugs: droxidopa
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

- Orthostatic hypotension due to autonomic nervous system failure Fall in systolic blood
pressure (supine to standing) of at least 20 mm Hg and diastolic blood pressure of at
least 15 mm Hg AND Symptoms of hypotension such as dizziness, light-headedness,
unsteadiness, dimming or blurred vision

- History of syncope or near-syncope

--Prior/Concurrent Therapy--

- Endocrine therapy: No concurrent adrenergics Concurrent fludrocortisone allowed

- Other: Concurrent indomethacin, support garments, and high salt diets allowed
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2006
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York

Funding & Sponsors
Primary sponsor type
Other
Name
Icahn School of Medicine at Mount Sinai
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Please note that the continuation study can be found at
http://clinicaltrials.gov/show/NCT00633880.

RATIONALE: Neurogenic hypotension is a fall in blood pressure that occurs when one moves from
a lying down to a standing position or after eating a meal. It causes one to feel dizzy,
light headed, and weak. Neurogenic hypotension is caused by a problem in the part of the
nervous system that controls such functions as heart rate and blood pressure. Droxidopa, a
drug that may increase blood pressure, may be an effective treatment for neurogenic
hypotension.

PURPOSE: Clinical trial to study the effectiveness of droxidopa in treating patients who have
neurogenic hypotension.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00004478
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Horacio Kaufmann, MD
Address 0 0
NYU Langone Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries