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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004478
Other study ID # 199/14180
Secondary ID MTS-GCO-98-243-3
Status Completed
Phase N/A
First received October 18, 1999
Last updated September 17, 2008
Start date March 1999
Est. completion date March 2006

Study information

Verified date September 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment


Intervention

Drug:
droxidopa


Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Epub 2003 Jul 28. — View Citation

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