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Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430494
First Posted: September 8, 2011
Last Update Posted: April 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
July 29, 2011
September 8, 2011
April 23, 2015
June 2011
October 2014   (Final data collection date for primary outcome measure)
Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ]
Same as current
Complete list of historical versions of study NCT01430494 on ClinicalTrials.gov Archive Site
  • Patient-reported pain [ Time Frame: every 6 months ]
  • SF-12 Scores [ Time Frame: every 6 months ]
  • ADPKD-Impact Scale Score [ Time Frame: every 6 months ]
  • Cost of care [ Time Frame: every 6 months ]
  • EQ-5D Scores [ Time Frame: Every 6 months ]
Same as current
Not Provided
Not Provided
 
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Not Provided
No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3409
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • existing diagnosis of ADPKD by modified-Ravine criteria
  • Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

Exclusion Criteria:

  • Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
Sexes Eligible for Study: All
12 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Italy,   Japan,   Netherlands,   Norway,   Poland,   Romania,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
 
 
NCT01430494
156-10-291
No
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization, Inc.
April 2015