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Droxidopa in Treating Patients With Neurogenic Hypotension

Study of Droxidopa in Patients With Neurologic Hypotension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004478
Enrollment
Unknown
Registered
1999-10-19
Start date
1999-03-31
Completion date
2006-03-31
Last updated
2008-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension, Shy-Drager Syndrome

Keywords

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

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.

Detailed description

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.

Interventions

DRUGdroxidopa

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026