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NCT00657046 · ClinicalTrials.gov registry record · Phase 2
Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension
A Phase 2 study of Intradialytic Hypotension, sponsored by Chelsea Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT00657046: Completed Phase 2 study of Intradialytic Hypotension, sponsored by Chelsea Therapeutics.
NCT00657046 is a Phase 2 study of Intradialytic Hypotension that has completed, run by Chelsea Therapeutics. The registered enrollment target is 85 participants, roughly in line with the 79-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657046, a Phase 2 study of Intradialytic Hypotension, has completed, sponsored by Chelsea Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well as reducing the severity and frequency of symptoms of orthostatic hypotension in these patients. The efficacy of droxidopa in ameliorating symptoms in patients undergoing dialysis has also been demonstrated in the literature and clinical trials conducted in Japan. The current study will investigate the clinical efficacy of two different doses of droxidopa in patients with intradialytic hypotension over a 4 week treatment period with a placebo control. The clinical efficacy will be evaluated by changes in hypotension- related symptoms, as well as changes in blood pressure prior to, during and following, HD sessions as compared to their pre-treatment baseline values.
Primary Outcome
Change between average baseline (visits 2-7) mean arterial blood pressure during hemodialysis and average treatment (visits 14-19) mean arterial blood pressure during hemodialysis. The calculation of MAP was based on the systolic (SBP) and diastolic (DBP) blood pressure measurements taken during each valid HD session, using the traditional formula: MAP = (SBP+2\*DBP)/3 for each time-point. The mean of the intradialytic measurements was calculated for each valid HD session, and these daily mean
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Droxidopa
Study Locations (1)
Oregon
- Rogue Valley Dialysis - Medford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00657046 record still lists
NCT00657046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, roughly in line with the 79-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target.
The record links to 1 condition, with Intradialytic Hypotension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00657046 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT00657046 about?
NCT00657046 is a clinical study titled "Safety and Benefit Study of Droxidopa to Treat Patients With Intradialytic Hypotension". In clinical trials in Japan, droxidopa has been shown to be effective in affecting blood pressure changes upon orthostatic challenge in patients with autonomic dysfunction, as well as reducing the severity and frequency of symptoms of orthostatic hypotension in these patients. The efficacy of droxid...
What is the current status of trial NCT00657046?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2007-12. Estimated completion is 2009-01.
What conditions does trial NCT00657046 study?
This clinical trial studies the following conditions: Intradialytic Hypotension.
What interventions are being tested in trial NCT00657046?
The interventions under investigation include: Placebo (DRUG), Droxidopa (DRUG).
Who is sponsoring clinical trial NCT00657046?
This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00657046 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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