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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.

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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

FieldValue
Enrollment Target 1,083 participants
Start Date 2010-05-26
Est. Completion 2016-02-29
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.