Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01430494 |
Recruitment Status
:
Completed
First Posted
: September 8, 2011
Last Update Posted
: April 23, 2015
|
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | July 29, 2011 | |||
First Posted Date | September 8, 2011 | |||
Last Update Posted Date | April 23, 2015 | |||
Study Start Date | June 2011 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01430494 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
|
|||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease | |||
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 | |||
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 | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD. | |||
Condition | Autosomal Dominant Polycystic Kidney Disease (ADPKD) | |||
Intervention | Not Provided | |||
Study Groups/Cohorts | No treatment | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
3409 | |||
Original Estimated Enrollment |
3000 | |||
Actual Study Completion Date | October 2014 | |||
Actual Primary Completion Date | October 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 12 Years to 70 Years (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01430494 | |||
Other Study ID Numbers | 156-10-291 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Otsuka Pharmaceutical Development & Commercialization, Inc. | |||
Study Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. | |||
Collaborators | Otsuka Pharmaceutical Co., Ltd. | |||
Investigators |
|
|||
PRS Account | Otsuka Pharmaceutical Development & Commercialization, Inc. | |||
Verification Date | April 2015 |