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NCT00413777 · ClinicalTrials.gov registry record · Phase 2

Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target

NCT00413777 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 46 participants.

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The verdict

NCT00413777, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target

Study Summary

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Interventions

  • DRUG Tolvaptan

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2005-12
Est. Completion 2010-06
Phase Phase 2

What the Registry Record Tells You About NCT00413777

The ClinicalTrials.gov registry entry for NCT00413777 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 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.

NCT00413777 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00413777 about?

NCT00413777 is a clinical study titled "Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)". This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

What is the current status of trial NCT00413777?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2005-12. Estimated completion is 2010-06.

What interventions are being tested in trial NCT00413777?

The interventions under investigation include: Tolvaptan (DRUG).

Who is sponsoring clinical trial NCT00413777?

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.