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NCT01430494 · ClinicalTrials.gov registry record

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

A clinical trial of Autosomal Dominant Polycystic Kidney Disease (ADPKD), sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
3,409
Enrollment target
20
Study locations

NCT01430494: Completed study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT01430494 is a study of Autosomal Dominant Polycystic Kidney Disease (ADPKD) that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 3,409 participants, above the 110-participant average among 5 other Autosomal Dominant Polycystic Kidney Disease (ADPKD) trials with a reported enrollment target (2999% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01430494, a study of Autosomal Dominant Polycystic Kidney Disease (ADPKD), has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
3,409 participants
Enrollment target
20
Study locations

Study Summary

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

Study Locations (20)

California

  • Otsuka Investigational Site - Azusa
  • Otsuka Investigational Site - Bakersfield
  • Otsuka Investigational Site - Los Angeles
  • Otsuka Investigational Site - Los Angeles
  • Otsuka Investigational Site - Ontario
  • Otsuka Investigational Site - San Diego

Florida

  • Otsuka Investigational Site - Coral Gables
  • Otsuka Investigational Site - Hudson
  • Otsuka Investigational Site - Jacksonville
  • Otsuka Investigational Site - Melbourne
  • Otsuka Investigational Site - Port Charlotte
  • Otsuka Investigational Site - Tampa

Arizona

  • Otsuka Investigational Site 1 - Peoria
  • Otsuka Investigational Site 2 - Peoria
  • Otsuka Investigational Site - Tempe

Colorado

  • Otsuka Investigational Site - Arvada
  • Otsuka Investigational Site - Aurora
  • Otsuka Investigational Site - Denver

Connecticut

  • Otsuka Investigational Site - New Haven

District of Columbia

  • Otsuka Investigational Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 3,409 participants
Start Date 2011-06
Est. Completion 2014-10

What the finished NCT01430494 record still lists

NCT01430494 is an observational study that tracks outcomes without assigning an intervention. Its 3,409 participants enrollment target places it among the larger protocols in the corpus, above the 110-participant average among 5 other Autosomal Dominant Polycystic Kidney Disease (ADPKD) trials with a reported enrollment target (2999% higher).

The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease (ADPKD) appearing as the primary indexed condition, and to 0 interventions.

NCT01430494 names 20 study sites across 6 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT01430494 about?

NCT01430494 is a clinical study titled "Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease". To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population ...

What is the current status of trial NCT01430494?

This trial is currently completed. The enrollment target is 3,409 participants. The study started on 2011-06. Estimated completion is 2014-10.

What conditions does trial NCT01430494 study?

This clinical trial studies the following conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Who is sponsoring clinical trial NCT01430494?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01430494 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01430494, the US trial registry maintained by the National Library of Medicine. NCT01430494 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.