CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 263 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00782340
NCT00782340Phase 3Completed

Phase III, Multi-Center, Study to Assess the Clinical Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic NOH

Chelsea Therapeutics·interventional·Posted Oct 31, 2008·Updated May 16, 2014

In Brief

A Phase 3 clinical trial evaluating Placebo and Droxidopa for Symptomatic Neurogenic Orthostatic Hypotension (NOH) and 3 related conditions. Completed, enrolled 263 participants across 21 sites in 2 countries.

Detailed Summary

The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartSep 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.7 years ago

Interventions

Placebodrug

100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day

Droxidopadrug

100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day