Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02251275 · ClinicalTrials.gov registry record · Phase 3
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,803
- Enrollment target
NCT02251275: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02251275 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,803 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (134% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02251275, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,803 participants
- Enrollment target
Study Summary
The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
Primary Outcome
An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapac
Interventions
- DRUG Tolvaptan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,803 participants |
| Start Date | 2014-10-17 |
| Est. Completion | 2018-11-09 |
| Phase | Phase 3 |
What the finished NCT02251275 record still lists
NCT02251275 is an interventional study that assigns participants to a tested intervention. Its 1,803 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 (134% higher).
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT02251275 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02251275 about?
NCT02251275 is a clinical study titled "Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease". The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).
What is the current status of trial NCT02251275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,803 participants. The study started on 2014-10-17. Estimated completion is 2018-11-09.
What interventions are being tested in trial NCT02251275?
The interventions under investigation include: Tolvaptan (DRUG).
Who is sponsoring clinical trial NCT02251275?
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 NCT02251275's enrollment target sits among peer trials
1,803 118th of 2000 higher than 1,883 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05935007 · 1,805 participants
Aveir DR Real-World Evidence Post-Approval Study
- NCT03630055 · 1,800 participants · Phase 3
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
- NCT04475640 · 1,800 participants · NA
Cancer Genetic Testing in Ethnic Populations
- NCT04980794 · 1,800 participants · NA
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI