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NCT01451827 · ClinicalTrials.gov registry record · Phase 2
8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 178
- Enrollment target
NCT01451827: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01451827 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 178 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451827, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 178 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
Primary Outcome
The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.
Interventions
- DRUG Placebo
- DRUG Tolvaptan MR
- DRUG Tolvaptan IR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 2 |
What the finished NCT01451827 record still lists
NCT01451827 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01451827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01451827 about?
NCT01451827 is a clinical study titled "8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD)". The purpose of this study is to compare the short-term effects of two tolvaptan formulations in patients with ADPKD.
What is the current status of trial NCT01451827?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2011-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01451827?
The interventions under investigation include: Placebo (DRUG), Tolvaptan MR (DRUG), Tolvaptan IR (DRUG).
Who is sponsoring clinical trial NCT01451827?
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 NCT01451827's enrollment target sits among peer trials
178 391st of 2000 higher than 1,607 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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