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NCT01210560 · ClinicalTrials.gov registry record · Phase 2
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
A Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 6
- Study locations
NCT01210560 is a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 25 participants, below the 159-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (84% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT01210560, a Phase 2 study of Autosomal Dominant Polycystic Kidney Disease, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 6
- Study locations
Study Summary
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1. To directly compare the immediate release (IR) and MR formulations 2. To determine the dose range and dose regimen for MR (dose finding)
Conditions Studied
Interventions
- DRUG Tolvaptan MR
- DRUG Tolvaptan IR
Study Locations (6)
Minnesota
- Davita Clinical Research - Minneapolis
- Mayo Medical Center - Rochester
Massachusetts
- Tufts-New England Medical Center - Boston
Ohio
- University Hospitals of Cleveland/Case - Cleveland
Oregon
- Northwest Renal Clinic Inc. - Portland
Pennsylvania
- University of Pennsylvania Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01210560
The ClinicalTrials.gov registry entry for NCT01210560 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 159-participant average among 9 other Autosomal Dominant Polycystic Kidney Disease trials with a reported enrollment target (84% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease appearing as the primary indexed condition, and to 2 interventions - of which Tolvaptan MR is the first listed.
NCT01210560 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Minnesota, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01210560 about?
NCT01210560 is a clinical study titled "Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD". To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1. To directly compare the immediate release (IR) and MR formulations 2. To determine...
What is the current status of trial NCT01210560?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2010-10. Estimated completion is 2011-06.
What conditions does trial NCT01210560 study?
This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney Disease.
What interventions are being tested in trial NCT01210560?
The interventions under investigation include: Tolvaptan MR (DRUG), Tolvaptan IR (DRUG).
Who is sponsoring clinical trial NCT01210560?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01210560 being conducted?
This trial has 6 study locations across Massachusetts, Minnesota, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.