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NCT00506441 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
A Phase 3 study, sponsored by Tanabe Pharma Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT00506441: Completed Phase 3 study, sponsored by Tanabe Pharma Corporation.
NCT00506441 is a Phase 3 study that has completed, run by Tanabe Pharma Corporation. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00506441, a Phase 3 study, has completed, sponsored by Tanabe Pharma Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study Summary
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
Primary Outcome
The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)
Interventions
- DRUG Placebo
- DRUG MCI-196
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00506441 record still lists
NCT00506441 is an interventional study that assigns participants to a tested intervention. The registered 245 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 (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00506441 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00506441 about?
NCT00506441 is a clinical study titled "A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia". This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.
What is the current status of trial NCT00506441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2007-09. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00506441?
The interventions under investigation include: Placebo (DRUG), MCI-196 (DRUG).
Who is sponsoring clinical trial NCT00506441?
This trial is sponsored by Tanabe Pharma Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00506441's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 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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