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COMPLETED

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT01430494 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01430494

The ClinicalTrials.gov registry entry for NCT01430494 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,409 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 79 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Autosomal Dominant Polycystic Kidney Disease (ADPKD) appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01430494 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT01430494?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 79 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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