Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-22 @ 3:05 PM
Study NCT ID:
NCT01430494
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2011-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Organization:
Study Overview
Official Title:
A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OVERTURE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: