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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01430494
First received: July 29, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported pain [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • SF-12 Scores [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • ADPKD-Impact Scale Score [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Cost of care [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • EQ-5D Scores [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430494

  Hide Study Locations
Locations
United States, Arizona
Otsuka Investigational Site 1
Peoria, Arizona, United States, 85381
Otsuka Investigational Site 2
Peoria, Arizona, United States, 85381
Otsuka Investigational Site
Tempe, Arizona, United States, 85284
United States, California
Otsuka Investigational Site
Azusa, California, United States, 91702
Otsuka Investigational Site
Bakersfield, California, United States, 93308
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Los Angeles, California, United States, 90022
Otsuka Investigational Site
Los Angeles, California, United States, 90025
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Ontario, California, United States, 91762
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San Diego, California, United States, 92108
United States, Colorado
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Arvada, Colorado, United States, 80002
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Aurora, Colorado, United States, 80045
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Denver, Colorado, United States, 80210
United States, Connecticut
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New Haven, Connecticut, United States, 06510
United States, District of Columbia
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Washington, District of Columbia, United States, 20037
United States, Florida
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Coral Gables, Florida, United States, 33146
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Hudson, Florida, United States, 34667
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Jacksonville, Florida, United States, 32216
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Melbourne, Florida, United States, 32935
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Port Charlotte, Florida, United States, 33952
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Tampa, Florida, United States, 33614
United States, Georgia
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Atlanta, Georgia, United States, 30322
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Augusta, Georgia, United States, 30901
United States, Idaho
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Meridian, Idaho, United States, 83642
United States, Illinois
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Chicago, Illinois, United States, 60637
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Peoria, Illinois, United States, 61602
United States, Indiana
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Mishawaka, Indiana, United States, 46545
United States, Kansas
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Kansas City, Kansas, United States, 66106
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Wichita, Kansas, United States, 67214
United States, Kentucky
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Lexington, Kentucky, United States, 40513
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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New Orleans, Louisiana, United States, 70121
United States, Maryland
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Baltimore, Maryland, United States, 21224
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Baltimore, Maryland, United States, 21201
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Bethesda, Maryland, United States, 20814
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Rockville, Maryland, United States, 20852
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Rockville, Maryland, United States, 20850
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Wheaton, Maryland, United States, 20906
United States, Massachusetts
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Boston, Massachusetts, United States, 02111
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Boston, Massachusetts, United States, 02215
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Holyoke, Massachusetts, United States, 01040
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Plymouth, Massachusetts, United States, 02360
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Springfield, Massachusetts, United States, 01107
United States, Michigan
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Detroit, Michigan, United States, 48236
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Kalamazoo, Michigan, United States, 49007
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Pontiac, Michigan, United States, 48341
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Royal Oak, Michigan, United States, 48073
United States, Minnesota
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Brooklyn Center, Minnesota, United States, 55430
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Rochester, Minnesota, United States, 55905
United States, Missouri
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St. Louis, Missouri, United States, 63110
United States, Nevada
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89115
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Reno, Nevada, United States, 89511
United States, New Jersey
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Mount Laurel, New Jersey, United States, 08054
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Princeton Junction, New Jersey, United States, 08550
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Voorhees, New Jersey, United States, 08043
United States, New Mexico
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Alburquerque, New Mexico, United States, 87109
United States, New York
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Albany, New York, United States, 12208
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Bronx, New York, United States, 10467
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Brooklyn, New York, United States, 11215
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Buffalo, New York, United States, 14215
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Flushing, New York, United States, 11355
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Forest Hills, New York, United States, 11375
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Great Neck, New York, United States, 11021
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Mineola, New York, United States, 11501
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New York, New York, United States, 10016
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New York, New York, United States, 10033
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New York, New York, United States, 10021
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Port Washington, New York, United States, 11050
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Rochester, New York, United States, 14642
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Rosedale, New York, United States, 11422
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Durham, North Carolina, United States, 27705
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Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
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Devils Lake, North Dakota, United States, 58301
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Fargo, North Dakota, United States, 58122
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Cincinnati, Ohio, United States, 45267
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Cleveland, Ohio, United States, 44106
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Columbus, Ohio, United States, 43210
United States, Oregon
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Portland, Oregon, United States, 97210
United States, Pennsylvania
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Altoona, Pennsylvania, United States, 16601
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Bethleham, Pennsylvania, United States, 18017
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Doylestown, Pennsylvania, United States, 18901
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Lancaster, Pennsylvania, United States, 17604
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Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
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Providence, Rhode Island, United States, 02904
United States, South Carolina
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Aiken, South Carolina, United States, 29801
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Anderson, South Carolina, United States, 29621
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Columbia, South Carolina, United States, 29209
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Columbia, South Carolina, United States, 29203
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Knoxville, Tennessee, United States, 37923
United States, Texas
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Arlington, Texas, United States, 76015
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77004
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Houston, Texas, United States, 77030
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Mission, Texas, United States, 78572
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San Antonio, Texas, United States, 78215
United States, Vermont
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Burlington, Vermont, United States, 05401
United States, Virginia
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Fairfax, Virginia, United States, 22030
United States, West Virginia
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Bluefield, West Virginia, United States, 24701
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Morgantown, West Virginia, United States, 26506
United States, Wisconsin
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Madison, Wisconsin, United States, 53713
Argentina
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Avellaneda, Buenos Aires, Argentina, 1872
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Junin, Buenos Aires, Argentina, 6000
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La Plata, Buenos Aires, Argentina, B1902AWL
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Pergamino, Buenos Aires, Argentina, 2700
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Pilar, Buenos Aires, Argentina, B16260DT
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Ciudad Autónoma de Buenos Aires, C.a.b.a., Argentina, C1429BWN
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Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
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Ciudad Autonoma de Buenos Aires, Argentina, C1425APQ
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Ciudad de Buenos Aires, Argentina, C1431FWO
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Ciudad de Buenos Aires, Argentina, C1155AHD
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Cordoba, Argentina, X5002HWE
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Cordoba, Argentina, X5016KEH
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Sante Fe, Argentina, 3000
Australia, New South Wales
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Liverpool, New South Wales, Australia, 2170
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Newcastle, New South Wales, Australia, 2305
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Sydney, New South Wales, Australia, 2065
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Sydney, New South Wales, Australia, 2031
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Sydney, New South Wales, Australia, 2050
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Sydney, New South Wales, Australia, 2139
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Westmead, New South Wales, Australia, 2145
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Tasmania
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Launceston, Tasmania, Australia, 7250
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Melbourne, Victoria, Australia, 3073
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Parkville, Victoria, Australia, 3050
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Richmond, Victoria, Australia, 3121
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Belgium
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Brussels, Belgium, 1200
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
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Belo Horizonte, MG, Brazil, 30180-060
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Juiz De Fora, MG, Brazil, 36036-330
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Curitiba, PR, Brazil, 80440-020
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Porto Alegre, RS, Brazil, 90610-000
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Porto Alegre, RS, Brazil, 90020-090
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Porto Alegre, RS, Brazil, 90035-003
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Joinville, SC, Brazil, 89227-680
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São José do Rio Preto, SP, Brazil, 15015-200
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São Paulo, SP, Brazil, 01323-001
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São Paulo, SP, Brazil, 01246-903
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São Paulo, Brazil, 04038-002
Canada, British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y2
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Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
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Brampton, Ontario, Canada, L6Z 4N5
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Edmonton, Ontario, Canada, T6G2B7
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Oakville, Ontario, Canada, L6J 3M5
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Scarborough, Ontario, Canada, M1H 3G4
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Toronto, Ontario, Canada, M4C 5T2
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Toronto, Ontario, Canada, M5B 1W8
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Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H3G 1A4
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Montreal, Quebec, Canada, H4J 1C5
Czech Republic
Otsuka Investigational Site
Ceske Budejovice, Czech Republic, 370 01
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Hradec Kralove, Czech Republic, 500 05
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Jihlava, Czech Republic, 586 33
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Liberec, Czech Republic, 460 63
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Praha 2, Czech Republic, 128 08
France
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Caen cedex 9, France, 14033
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Grenoble cedex, France, 38043
Otsuka Investigational Site
Lyon cedex 03, France, 69473
Otuska Investigational Site
Lyon cedex 3, France, 69437
Otsuka Investigational Site
Montpellier cedex, France, 34295
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Pierre-Bénite cedex, France, 69495
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Vandoeuvre-lès-Nancy cedex, France, 54511
Germany
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Berlin, Germany, 10117
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Dresden, Germany, 01307
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Düsseldorf, Germany, 40210
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Erlangen, Germany, 91054
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Hannover, Germany, 30625
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Heidelburg, Germany, 69120
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Munich, Germany, 81675
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Wiesbaden, Germany, 65191
Italy
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Rozzano, Milano, Italy, 20089
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Bologna, Italy, 40138
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Lecco, Italy, 23900
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Modena, Italy, 41100
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Montichiari, (Brescia), Italy, 25018
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Napoli, Italy, 80131
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Pavia, Italy, 27100
Japan
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Sagamihara-shi, Kanagawa, Japan, 252-0375
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Kurashiki-city, Okayama, Japan, 701-0192
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Chiba, Japan, 260-8712
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Fukuoka, Japan, 812-8582
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Hokkaido, Japan, 060-8638
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Niigata, Japan, 951-8520
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Osaka, Japan, 545-8586
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Osaka, Japan, 565-0871
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Tochigi, Japan, 329-0498
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Tokyo, Japan, 173-8606
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Tokyo, Japan, 113-8603
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Tokyo, Japan, 162-8666
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Tokyo, Japan, 113-8510
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Tokyo, Japan, 181-8611
Netherlands
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Groningen, Netherlands, 9700RB
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Leiden, Netherlands, 2333 ZA
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Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3015 CE
Norway
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Drammen, Norway, 3004
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Lillehammer, Norway, 2609
Poland
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Ciechanow, Poland, 06-400
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Golub-Dobrzyn, Poland, 87-400
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Krakow, Poland, 30-663
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Lodz, Poland, 93-338
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Radom, Poland, 26-610
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Rzeszów, Poland, 35-055
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Szczecin, Poland, 70-111
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Warsaw, Poland, 04-730
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Warszawa, Poland, 04-749
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Wroclaw, Poland, 50-556
Romania
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Oradea, Bihor, Romania, 410469
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Timisoara, Timis, Romania, 300736
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Bucuresti, Romania, 010731
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Bucuresti, Romania, 022328
Spain
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Alicante, Spain, 03010
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Barcelona, Spain, 08036
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Ciudad Real, Spain, 13005
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Hospitalet de Ilobre, Spain, 08907
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Madrid, Spain, 28046
Sweden
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Malmö, Sweden, 20502
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Stockholm, Sweden, 14186
Switzerland
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Zürich, Switzerland, 8091
Turkey
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Istanbul, Capa, Turkey, 34390
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Inciralti, Izmir, Turkey, 35340
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Balcali-Adana, Turkey, 1330
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Bornova-Izmir, Turkey, 35100
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Izmir, Turkey, 35100
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Sihhiye-Ankara, Turkey, 6100
United Kingdom
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Exeter, Devon, United Kingdom, EX2 5DW
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York, North Yorkshire, United Kingdom, YO31 8HE
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Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
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Carshalton, Surrey, United Kingdom, SM5 1AA
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Birmingham, West Midlands, United Kingdom, B4 6NH
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Belfast, United Kingdom, BT9 7AB
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Bradford, United Kingdom, BD5 0NA
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Bristol, United Kingdom, BS2 8BJ
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Cambridge, United Kingdom, CB2 0QQ
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Chelmsford, United Kingdom, CM1 7ET
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Coventry, United Kingdom, CV2 2DX
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Dorchester, United Kingdom, DT1 2JY
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Edinburgh, United Kingdom, EH16 4SA
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Hull, United Kingdom, HU3 2JZ
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Inverness, United Kingdom, IV2 3UJ
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Kirkcaldy, United Kingdom, KY2 5AH
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Leicester, United Kingdom, LE5 4PW
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, SW17 0QT
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London, United Kingdom, WC1N 3JH
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London, United Kingdom, NW3 2QG
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Manchester, United Kingdom, M13 9WL
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Middlesbrough, United Kingdom, TS4 3BW
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
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Oxford, United Kingdom, OX3 7LJ
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Portsmouth, United Kingdom, PO6 3LY
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Preston, United Kingdom, PR2 9HT
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Salford, United Kingdom, M6 8HD
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Sheffield, United Kingdom, S5 7AU
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Southampton, United Kingdom, SO16 6YD
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Stevenage, United Kingdom, SG1 4AB
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Westcliff-on-Sea, United Kingdom, SS0 0RY
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Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Frank Czerwiec, MD, PhD Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01430494     History of Changes
Other Study ID Numbers: 156-10-291
Study First Received: July 29, 2011
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Disease Progression
Urologic Diseases
Kidney Diseases, Cystic
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014