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NCT01214421 · ClinicalTrials.gov registry record · Phase 3
Tolvaptan Extension Study in Participants With ADPKD
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,083
- Enrollment target
NCT01214421: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01214421 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,083 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01214421, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,083 participants
- Enrollment target
Study Summary
To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
Primary Outcome
Total kidney volume is a measure of disease progression in the ADPKD participants. Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, radiologists used proprietary software to measure the volume of both kidneys in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously tre
Interventions
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,083 participants |
| Start Date | 2010-05-26 |
| Est. Completion | 2016-02-29 |
| Phase | Phase 3 |
What the finished NCT01214421 record still lists
NCT01214421 is an interventional study that assigns participants to a tested intervention. Its 1,083 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT01214421 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01214421 about?
NCT01214421 is a clinical study titled "Tolvaptan Extension Study in Participants With ADPKD". To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.
What is the current status of trial NCT01214421?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,083 participants. The study started on 2010-05-26. Estimated completion is 2016-02-29.
What interventions are being tested in trial NCT01214421?
The interventions under investigation include: Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT01214421?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01214421's enrollment target sits among peer trials
1,083 269th of 2000 higher than 1,732 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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