Treatment of Orthostatic Hypotension

Phase 3TerminatedNCT00581477

Vanderbilt University8 enrolled

Overview

The purpose of this study is to try different medications in patients with low blood pressure and other problems with their involuntary (autonomic) nervous system. The pharmacological trials in this study will perhaps lead to more effective treatment. The protocol includes single dose trials, dose-selection trials, 5-day trials and chronic (approximately 2 months) trials, although only dose-selection trials were consistently performed and have results presented.

We see many patients at the Autonomic Dysfunction Center who can be given a fairly definitive diagnosis, e.g., Orthostatic Intolerance, Pure Autonomic Failure, Multiple System Atrophy, and Baroreflex Failure. However, some patients present with a unique constellation of symptoms of autonomic dysfunction so that they do not fit into a diagnostic category. We hypothesize that a genetic cause exists in some of these patients. We further propose that our comprehensive evaluation of these patients will provide us with information on the pathophysiology of their condition and assist us in optimizing their treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autonomic Nervous System Diseases Orthostatic Hypotension Dopamine Beta-Hydroxylase Deficiency Orthostatic Intolerance

Interventions

Droxidopa Oral ProductDRUG

Droxidopa administered in increasing dosages up to 300 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with severe orthostatic hypotension and other autonomic symptoms who do not meet criteria for one of our standard diagnoses * non-smokers * drug-free * able to give informed consent * free of pulmonary, renal, hematopoietic, hepatic and cardiac disease Exclusion Criteria: * medications affecting the autonomic nervous system * any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) * anemia (Hct \< 30) * women of childbearing age who are pregnant or nursing * smokers

Locations (1)

Vanderbilt University

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure With Standing

The difference between upright and supine systolic blood pressures (dSBP; upright - supine) was calculated for each patient at 60-240 minutes after each dose of droxidopa. For each post-dose timepoint and study day, the average of up to three blood pressure readings per droxidopa dose was calculated. Dosing is individualized for each patient based upon how well the drug is tolerated and the degree of improvement in orthostatic vital signs and symptoms following drug administration. The dosages administered, as well as the number of timepoints and days, therefore, varied between patients.

Time frame: Up to 240 minutes post dose on Study Days 1, 2, 3 and 4.

Data from ClinicalTrials.gov

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