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NCT00738062 · ClinicalTrials.gov registry record · Phase 3
Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
A Phase 3 study, sponsored by Chelsea Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
NCT00738062: Completed Phase 3 study, sponsored by Chelsea Therapeutics.
NCT00738062 is a Phase 3 study that has completed, run by Chelsea Therapeutics. The registered enrollment target is 103 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00738062, a Phase 3 study, has completed, sponsored by Chelsea Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 103 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the durability of effect of Droxidopa 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.
Primary Outcome
The OHQ is the average of two sub-scales, the Orthostatic Hypotension Symptom Assessment Scale (OHSA) and the Orthostatic Hypotension Daily Activities Scale (OHDAS). Each asks the patient to rate their symptoms or disease impact over the past week. The OHSA sub-scale is the average of six items: 1) Dizziness, lightheadedness, feeling faint or feeling like you might black out; 2) Problems with vision; 3) Weakness; 4) Fatigue; 5) Trouble concentrating; and 6) Head/neck discomfort. The OHDAS sub-sc
Interventions
- DRUG Placebo
- DRUG Droxidopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00738062 record still lists
NCT00738062 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00738062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00738062 about?
NCT00738062 is a clinical study titled "Open-Label Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)". The purpose of this study is to assess the durability of effect of Droxidopa 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 defi...
What is the current status of trial NCT00738062?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2008-01. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00738062?
The interventions under investigation include: Placebo (DRUG), Droxidopa (DRUG).
Who is sponsoring clinical trial NCT00738062?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00738062's enrollment target sits among peer trials
103 1674th of 2000 higher than 325 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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