Droxidopa in Treating Patients With Neurogenic Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

1999-03-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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PROTOCOL OUTLINE:

Patients receive escalating doses of droxidopa or placebo for 7-14 days. Patients undergo blood pressure measurements hourly in both supine and standing positions.

Conditions

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Shy-Drager Syndrome Orthostatic Hypotension

Keywords

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Shy-Drager Syndrome cardiovascular and respiratory diseases neurologic and psychiatric disorders orthostatic hypotension rare disease

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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droxidopa

Intervention Type DRUG

Eligibility Criteria

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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 Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Horacio Kaufmann, MD

Role: STUDY_CHAIR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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Kaufmann H, Saadia D, Voustianiouk A, Goldstein DS, Holmes C, Yahr MD, Nardin R, Freeman R. Norepinephrine precursor therapy in neurogenic orthostatic hypotension. Circulation. 2003 Aug 12;108(6):724-8. doi: 10.1161/01.CIR.0000083721.49847.D7. Epub 2003 Jul 28.

Reference Type RESULT

PMID: 12885750 (View on PubMed)

Goldstein DS, Holmes C, Kaufmann H, Freeman R. Clinical pharmacokinetics of the norepinephrine precursor L-threo-DOPS in primary chronic autonomic failure. Clin Auton Res. 2004 Dec;14(6):363-8. doi: 10.1007/s10286-004-0221-z.