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: March 13, 2013
Last verified: March 2013
  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: June 2014
Estimated Primary Completion Date: June 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430494

  Hide Study Locations
Locations
United States, Alabama
Otsuka Investigational Site
Mobile, Alabama, United States, 36617
United States, Arizona
Otsuka Investigational Site 1
Peoria, Arizona, United States, 85381
Otsuka Investigational Site 2
Peoria, Arizona, United States, 85381
Otsuka Investigational Site
Phoenix, Arizona, United States, 85012
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
Otsuka Investigational Site
Los Angeles, California, United States, 90022
Otsuka Investigational Site
Los Angeles, California, United States, 90025
Otsuka Investigational Site
Los Angeles, California, United States, 90033
Otsuka Investigational Site
Ontario, California, United States, 91762
Otsuka Investigational Site
Whittier, California, United States, 90603
United States, Colorado
Otsuka Investigational Site
Arvada, Colorado, United States, 80002
Otsuka Investigational Site
Aurora, Colorado, United States, 80045
Otsuka Investigational Site
Denver, Colorado, United States, 80210
United States, Connecticut
Otsuka Investigational Site
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
Otsuka Investigational Site
Coral Gables, Florida, United States, 33146
Otsuka Investigational Site
Coral Springs, Florida, United States, 33071
Otsuka Investigational Site
Hudson, Florida, United States, 34667
Otsuka Investigational Site
Jacksonville, Florida, United States, 32216
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Port Charlotte, Florida, United States, 33952
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Tampa, Florida, United States, 33614-7151
United States, Georgia
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Atlanta, Georgia, United States, 30322
Otsuka Investigational Site
Augusta, Georgia, United States, 30901
United States, Idaho
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Meridian, Idaho, United States, 83642
United States, Illinois
Otsuka Investigational Site
Chicago, Illinois, United States, 60637
United States, Kansas
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Kansas City, Kansas, United States, 66160
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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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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, 48073-6710
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, 89502
United States, New Jersey
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Mount Laurel, New Jersey, United States, 08054-4103
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Paterson, New Jersey, United States, 07503
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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, 87102
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, 11021-5501
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Mineola, New York, United States, 11501-4237
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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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Fargo, North Dakota, United States, 58122
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Grand Forks, North Dakota, United States, 58201
United States, Ohio
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Cincinnati, Ohio, United States, 45267-0585
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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, 18901-2554
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Erie, Pennsylvania, United States, 16507
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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, 02904-2611
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, 26506-9165
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, C1425APQ
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Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
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Ciudad de Buenos Aires, Argentina, C1431FWO
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Ciudad de Buenos Aires, Argentina, 1155
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Cordoba, Argentina, X5002HWE
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Cordoba, Argentina, 5016
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Sante Fe, Argentina, 3000
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Concord, New South Wales, Australia, 2139
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Liverpool, New South Wales, Australia, 2170
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Newcastle, New South Wales, Australia, 2305
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Randwick, New South Wales, Australia, 2031
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St. Leonards, New South Wales, Australia, 2065
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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, 3131
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Melbourne, Victoria, Australia, 3073
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Parkville, Victoria, Australia, 3050
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Belgium
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Leuven, Belgium, 3000
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Sint Lambrechts Woluwe, Belgium, 1200
Brazil
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Salvador, BA, Brazil, 40110-160
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São Luíz, MA, Brazil, 65070-905
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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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Rio de Janeiro, RJ, Brazil, 21041-070
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Rio de Janeiro, RJ, Brazil, 20551-030
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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, 04039-000
Canada, Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
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Brampton, Ontario, Canada, L6Z 4N5
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Edmonton, Ontario, Canada, T662B7
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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
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H4J 1C5
Czech Republic
Otsuka Investigational Site
Ceske Budejovice, Czech Republic, 370 01
Otsuka Investigational Site
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
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Tábor, Czech Republic, 390 03
France
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Caen, France, 14000
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Grenoble, France, 38100
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Lyon, France, 69437
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Montpellier, France, 34000
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Pierre-Benite, France, 69495
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Vandoeuvre les nancy, France, 54511
Germany
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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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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Brescia, Italy
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Cremona, Italy, 26100
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Lecco, Italy, 23900
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Modena, Italy, 41100
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Napoli, Italy, 80131
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Pavia, Italy, 27100
Netherlands
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Groningen, Netherlands, 9700RB
Norway
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Drammen, Norway, 3004
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Lillehammer, Norway, 2629
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, 70111
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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, 410159
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Timisoara, Timis, Romania, 300736
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Bucharest, Romania, 10701
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Bucharest, Romania, 22328
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Bucuresti, Romania, 022328
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Iasi, Romania
Spain
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Alicante, Spain, 3010
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Barcelona, Spain, 8036
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Ciudad Real, Spain, 13005
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Hospitalet de Ilobre, Spain, 8907
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Madrid, Spain, 28046
Sweden
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Malmö, Sweden, 20502
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Stockholm, Sweden, 14186
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Värnamo, Sweden, 33185
Switzerland
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Zürich, Switzerland, 8091
Turkey
Otsuka Investigational Site
Balcali, Adana, Turkey, 1330
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Istanbul, Capa, Turkey, 34390
Otsuka Investigational Site
Kadıköy, Istanbul, Turkey, 34722
Otsuka Investigational Site
Inciralti, Izmir, Turkey, 35340
Otsuka Investigational Site
Balcali-Adana, Turkey, 1330
Otsuka Investigational Site
Bornova-Izmir, Turkey, 35100
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Izmir, Turkey, 35100
Otsuka Investigational Site
Sihhiye-Ankara, Turkey, 6100
United Kingdom
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Exeter, Devon, United Kingdom, EX2 5DW
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Edinburgh, Scotland, United Kingdom, EH16 4SA
Otsuka Investigational Site
Carshalton, Surrey, United Kingdom, SM5 1AA
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Belfast, United Kingdom, BT9 7ABB
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Cambridge, United Kingdom, CB2 0QQ
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Coventry, United Kingdom, CV2 2DX
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Dorchester, United Kingdom, DT1 2JY
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Dunfermline, United Kingdom, KY12 0SU
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Inverness, United Kingdom, IV2 3UJ
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Leicester, United Kingdom, LE5 4PW
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London, United Kingdom, NW3 2PF
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London, United Kingdom, WC1N 3JH
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
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Oxford, United Kingdom, OX3 7LJ
Otsuka Investigational Site
Salford, United Kingdom, M6 8HD
Otsuka Investigational Site
Sheffield, United Kingdom, S5 7AU
Otsuka Investigational Site
Shirley, United Kingdom, SO16 6YD
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: March 13, 2013
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 May 23, 2013