Droxidopa in Treating Patients With Neurogenic Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

Study of Droxidopa in Patients With Neurologic Hypotension

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Orthostatic Hypotension
• Shy-Drager Syndrome

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