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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 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 1,083 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01214421
The ClinicalTrials.gov registry entry for NCT01214421 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,083 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tolvaptan is the first listed.
NCT01214421 reports 0 study locations.
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.
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