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NCT00581477 · ClinicalTrials.gov registry record · Phase 2

Treatment of Orthostatic Hypotension

A Phase 2 study, sponsored by Vanderbilt University.

Terminated
Registry status
Phase 2
Development phase
8
Enrollment target

NCT00581477: Clinical Trial Phase 2 study, sponsored by Vanderbilt University.

NCT00581477 is a Phase 2 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00581477, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University.

TERMINATED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study Summary

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.

Primary Outcome

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 a

Interventions

  • DRUG Droxidopa Oral Product

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2004-01
Est. Completion 2020-12
Phase Phase 2
Vanderbilt University

430 total trials

Why NCT00581477 stopped before completion

NCT00581477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Droxidopa Oral Product is the first listed.

NCT00581477 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00581477 about?

NCT00581477 is a clinical study titled "Treatment of Orthostatic Hypotension". 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-s...

What is the current status of trial NCT00581477?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2004-01. Estimated completion is 2020-12.

What interventions are being tested in trial NCT00581477?

The interventions under investigation include: Droxidopa Oral Product (DRUG).

Who is sponsoring clinical trial NCT00581477?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00581477's enrollment target sits among peer trials

8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00581477, the US trial registry maintained by the National Library of Medicine. NCT00581477 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.