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NCT00324376 · ClinicalTrials.gov registry record · Phase 2
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
A Phase 2 study, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00324376 is a Phase 2 study that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 24 participants.
The verdict
NCT00324376, a Phase 2 study, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.
Interventions
- DRUG Sevelamer hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2003-03 |
| Est. Completion | 2004-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00324376
The ClinicalTrials.gov registry entry for NCT00324376 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sevelamer hydrochloride is the first listed.
NCT00324376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00324376 about?
NCT00324376 is a clinical study titled "Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing". A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two wee...
What is the current status of trial NCT00324376?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2003-03. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00324376?
The interventions under investigation include: Sevelamer hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00324376?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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