Clinical trial NCT01430494: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2011-09-08
Enrollment: 3409
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.

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.


Eligibility 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

Primary outcomes:
measure: Correlation of change in total kidney volume with ADPKD-related outcomes
timeFrame: 1 year
Secondary outcomes:
measure: Patient-reported pain
timeFrame: every 6 months
measure: SF-12 Scores
timeFrame: every 6 months
measure: ADPKD-Impact Scale Score
timeFrame: every 6 months
measure: Cost of care
timeFrame: every 6 months
measure: EQ-5D Scores
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Otsuka Investigational Site 1
state: Arizona
city: Peoria
country: United States
facility: Otsuka Investigational Site 2
state: Arizona
city: Tempe
country: United States
facility: Otsuka Investigational Site
state: Arizona
city: Azusa
country: United States
facility: Otsuka Investigational Site
state: California
city: Bakersfield
country: United States
facility: Otsuka Investigational Site
state: California
city: Los Angeles
country: United States
facility: Otsuka Investigational Site
state: California
city: Los Angeles
country: United States
facility: Otsuka Investigational Site
state: California
city: Ontario
country: United States
facility: Otsuka Investigational Site
state: California
city: San Diego
country: United States
facility: Otsuka Investigational Site
state: California
city: Arvada
country: United States
facility: Otsuka Investigational Site
state: Colorado
city: Aurora
country: United States
facility: Otsuka Investigational Site
state: Colorado
city: Denver
country: United States
facility: Otsuka Investigational Site
state: Colorado
city: New Haven
country: United States
facility: Otsuka Investigational Site
state: Connecticut
city: Washington
country: United States
facility: Otsuka Investigational Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Hudson
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Tampa
country: United States
facility: Otsuka Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Otsuka Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Otsuka Investigational Site
state: Georgia
city: Meridian
country: United States
facility: Otsuka Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Otsuka Investigational Site
state: Illinois
city: Peoria
country: United States
facility: Otsuka Investigational Site
state: Illinois
city: Mishawaka
country: United States
facility: Otsuka Investigational Site
state: Indiana
city: Kansas City
country: United States
facility: Otsuka Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Otsuka Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Otsuka Investigational Site
state: Kentucky
city: Paducah
country: United States
facility: Otsuka Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Otsuka Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Rockville
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Otsuka Investigational Site
state: Maryland
city: Boston
country: United States
facility: Otsuka Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Otsuka Investigational Site
state: Massachusetts
city: Holyoke
country: United States
facility: Otuska Investigational Site
state: Massachusetts
city: Plymouth
country: United States
facility: Otsuka Investigational Site
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city: Springfield
country: United States
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state: Massachusetts
city: Detroit
country: United States
facility: Otsuka Investigational Site
state: Michigan
city: Kalamazoo
country: United States
facility: Otsuka Investigational Site
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city: Pontiac
country: United States
facility: Otsuka Investigational Site
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city: Royal Oak
country: United States
facility: Otsuka Investigational Site
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city: Brooklyn Center
country: United States
facility: Otsuka Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Otsuka Investigational Site
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city: St. Louis
country: United States
facility: Otsuka Investigational Site
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city: Las Vegas
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facility: Otsuka Investigational Site
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city: Las Vegas
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city: Reno
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state: New Jersey
city: Princeton Junction
country: United States
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city: Voorhees
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state: New Mexico
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city: Bronx
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city: Buffalo
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state: New York
city: Flushing
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state: New York
city: Forest Hills
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state: New York
city: Great Neck
country: United States
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state: New York
city: Mineola
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
facility: Otsuka Investigational Site
state: New York
city: Port Washington
country: United States
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state: New York
city: Rochester
country: United States
facility: Otsuka Investigational Site
state: New York
city: Rosedale
country: United States
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state: New York
city: Chapel Hill
country: United States
facility: Otsuka Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Otsuka Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Otsuka Investigational Site
state: North Carolina
city: Devils Lake
country: United States
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city: Fargo
country: United States
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state: Rhode Island
city: Aiken
country: United States
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city: Anderson
country: United States
facility: Otsuka Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Otsuka Investigational Site
state: South Carolina
city: Columbia
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
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country: United States
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state: Tennessee
city: Arlington
country: United States
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state: Texas
city: Fort Worth
country: United States
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country: United States
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state: Texas
city: Mission
country: United States
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country: United States
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country: United States
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country: United States
facility: Otsuka Investigational Site
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country: United States
facility: Otsuka Investigational Site
state: West Virginia
city: Morgantown
country: United States
facility: Otsuka Investigational Site
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country: United States
facility: Otsuka Investigational Site
state: Wisconsin
city: Avellaneda
country: Argentina
facility: Otsuka Investigational Site
state: Buenos Aires
city: Junin
country: Argentina
facility: Otsuka Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Otsuka Investigational Site
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city: Pergamino
country: Argentina
facility: Otsuka Investigational Sites
state: Buenos Aires
city: Pilar
country: Argentina
facility: Otsuka Investigational Site
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Otsuka Investigational Site
state: C.a.b.a.
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Otsuka Investigational Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Otsuka Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Otsuka Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
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city: Cordoba
country: Argentina
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city: Cordoba
country: Argentina
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city: Sante Fe
country: Argentina
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city: Liverpool
country: Australia
facility: Otsuka Investigational Site
state: New South Wales
city: Newcastle
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Sydney
country: Australia
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state: New South Wales
city: Westmead
country: Australia
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state: New South Wales
city: Adelaide
country: Australia
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state: South Australia
city: Launceston
country: Australia
facility: Otsuka Investigational Site
state: Tasmania
city: Clayton
country: Australia
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state: Victoria
city: Melbourne
country: Australia
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state: Victoria
city: Parkville
country: Australia
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state: Victoria
city: Richmond
country: Australia
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state: Victoria
city: Perth
country: Australia
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state: Western Australia
city: Brussels
country: Belgium
facility: Otsuka Investigational Site
city: Gent
country: Belgium
facility: Otsuka Investigational Site
city: Leuven
country: Belgium
facility: Otsuka Investigational Site
city: Belo Horizonte
country: Brazil
facility: Otsuka Investigational Site
state: MG
city: Juiz De Fora
country: Brazil
facility: Otsuka Investigational Site
state: MG
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country: Brazil
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state: PR
city: Porto Alegre
country: Brazil
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state: RS
city: Porto Alegre
country: Brazil
facility: Otsuka Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Otsuka Investigational Site
state: RS
city: Joinville
country: Brazil
facility: Otsuka Investigational Site
state: SC
city: São José do Rio Preto
country: Brazil
facility: Otsuka Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Otsuka Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Otsuka Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Otsuka Investigational Site
city: Vancouver
country: Canada
facility: Otsuka Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Otsuka Investigational Site
state: British Columbia
city: St. John's
country: Canada
facility: Otsuka Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Otsuka Investigational Site
state: Nova Scotia
city: Brampton
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Edmonton
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Otsuka Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
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state: Quebec
city: Montreal
country: Canada
facility: Otsuka Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Otsuka Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Otsuka Investigational Site
state: Quebec
city: Ceske Budejovice
country: Czech Republic
facility: Otsuka Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Otsuka Investigational Site
city: Jihlava
country: Czech Republic
facility: Otsuka Investigational Site
city: Liberec
country: Czech Republic
facility: Otsuka Investigational Site
city: Praha 2
country: Czech Republic
facility: Otsuka Investigational Site
city: Caen cedex 9
country: France
facility: Otsuka Investigational Site
city: Grenoble cedex
country: France
facility: Otsuka Investigational Site
city: Lyon cedex 03
country: France
facility: Otsuka Investigational Site
city: Lyon cedex 3
country: France
facility: Otuska Investigational Site
city: Montpellier cedex
country: France
facility: Otsuka Investigational Site
city: Pierre-Bénite cedex
country: France
facility: Otsuka Investigational Site
city: Vandoeuvre-lès-Nancy cedex
country: France
facility: Otsuka Investigational Site
city: Berlin
country: Germany
facility: Otsuka Investigational Site
city: Dresden
country: Germany
facility: Otsuka Investigational Site
city: Düsseldorf
country: Germany
facility: Otsuka Investigational Site
city: Erlangen
country: Germany
facility: Otsuka Investigational Site
city: Hannover
country: Germany
facility: Otsuka Investigational Site
city: Heidelburg
country: Germany
facility: Otsuka Investigational Site
city: Munich
country: Germany
facility: Otsuka Investigational Site
city: Wiesbaden
country: Germany
facility: Otsuka Investigational Site
city: Rozzano
country: Italy
facility: Otsuka Investigational Site
state: Milano
city: Bologna
country: Italy
facility: Otsuka Investigational Site
city: Lecco
country: Italy
facility: Otsuka Investigational Site
city: Modena
country: Italy
facility: Otsuka Investigational Site
city: Montichiari, (Brescia)
country: Italy
facility: Otsuka Investigational Site
city: Napoli
country: Italy
facility: Otsuka Investigational Site
city: Pavia
country: Italy
facility: Otsuka Investigational Site
city: Sagamihara-shi
country: Japan
facility: Otsuka Investigational Site
state: Kanagawa
city: Kurashiki-city
country: Japan
facility: Otsuka Investigational Site
state: Okayama
city: Chiba
country: Japan
facility: Otsuka Investigational Site
city: Fukuoka
country: Japan
facility: Otsuka Investigational Site
city: Hokkaido
country: Japan
facility: Otsuka Investigational Site
city: Niigata
country: Japan
facility: Otsuka Investigational Site
city: Osaka
country: Japan
facility: Otsuka Investigational Site
city: Osaka
country: Japan
facility: Otsuka Investigational Site
city: Tochigi
country: Japan
facility: Otsuka Investigational Site
city: Tokyo
country: Japan
facility: Otsuka Investigational Site
city: Tokyo
country: Japan
facility: Otsuka Investigational Site
city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
facility: Otsuka Investigational Site
city: Groningen
country: Netherlands
facility: Otsuka Investigational Site
city: Leiden
country: Netherlands
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city: Nijmegen
country: Netherlands
facility: Otsuka Investigational Site
city: Rotterdam
country: Netherlands
facility: Otsuka Investigational Site
city: Drammen
country: Norway
facility: Otsuka Investigational Site
city: Lillehammer
country: Norway
facility: Otsuka Investigational Site
city: Ciechanow
country: Poland
facility: Otsuka Investigational Site
city: Golub-Dobrzyn
country: Poland
facility: Otsuka Investigational Site
city: Krakow
country: Poland
facility: Otsuka Investigational Site
city: Lodz
country: Poland
facility: Otsuka Investigational Site
city: Radom
country: Poland
facility: Otsuka Investigational Site
city: Rzeszów
country: Poland
facility: Otsuka Investigational Site
city: Szczecin
country: Poland
facility: Otsuka Investigational Site
city: Warsaw
country: Poland
facility: Otsuka Investigational Site
city: Warszawa
country: Poland
facility: Otsuka Investigational Site
city: Wroclaw
country: Poland
facility: Otsuka Investigational Site
city: Oradea
country: Romania
facility: Otsuka Investigational Site
state: Bihor
city: Timisoara
country: Romania
facility: Otsuka Investigational Site
state: Timis
city: Bucuresti
country: Romania
facility: Otsuka Investigational Site
city: Bucuresti
country: Romania
facility: Otsuka Investigational Site
city: Alicante
country: Spain
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city: Barcelona
country: Spain
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city: Ciudad Real
country: Spain
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city: Hospitalet de Ilobre
country: Spain
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city: Madrid
country: Spain
facility: Otsuka Investigational Site
city: Malmö
country: Sweden
facility: Otsuka Investigational Site
city: Stockholm
country: Sweden
facility: Otsuka Investigational Site
city: Zürich
country: Switzerland
facility: Otsuka Investigational Site
city: Istanbul
country: Turkey
facility: Otsuka Investigational Site
state: Capa
city: Inciralti
country: Turkey
facility: Otsuka Investigational Site
state: Izmir
city: Balcali-Adana
country: Turkey
facility: Otsuka Investigational Site
city: Bornova-Izmir
country: Turkey
facility: Otsuka Investigational Site
city: Izmir
country: Turkey
facility: Otsuka Investigational Site
city: Sihhiye-Ankara
country: Turkey
facility: Otsuka Investigational Site
city: Exeter
country: United Kingdom
facility: Otsuka Investigational Site
state: Devon
city: York
country: United Kingdom
facility: Otsuka Investigational Site
state: North Yorkshire
city: Stoke-on-Trent
country: United Kingdom
facility: Otsuka Investigational Site
state: Staffordshire
city: Carshalton
country: United Kingdom
facility: Otsuka Investigational Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Otsuka Investigational Site
state: West Midlands
city: Belfast
country: United Kingdom
facility: Otsuka Investigational Site
city: Bradford
country: United Kingdom
facility: Otsuka Investigational Site
city: Bristol
country: United Kingdom
facility: Otsuka Investigational Site
city: Cambridge
country: United Kingdom
facility: Otsuka Investigational Site
city: Chelmsford
country: United Kingdom
facility: Otsuka Investigational Site
city: Coventry
country: United Kingdom
facility: Otsuka Investigational Site
city: Dorchester
country: United Kingdom
facility: Otsuka Investigational Site
city: Edinburgh
country: United Kingdom
facility: Otsuka Investigational Site
city: Hull
country: United Kingdom
facility: Otsuka Investigational Site
city: Inverness
country: United Kingdom
facility: Otsuka Investigational Site
city: Kirkcaldy
country: United Kingdom
facility: Otsuka Investigational Site
city: Leicester
country: United Kingdom
facility: Otsuka Investigational Site
city: Liverpool
country: United Kingdom
facility: Otsuka Investigational Site
city: London
country: United Kingdom
facility: Otsuka Investigational Site
city: London
country: United Kingdom
facility: Otsuka Investigational Site
city: London
country: United Kingdom
facility: Otsuka Investigational Site
city: Manchester
country: United Kingdom
facility: Otsuka Investigational Site
city: Middlesbrough
country: United Kingdom
facility: Otsuka Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Otsuka Investigational Site
city: Oxford
country: United Kingdom
facility: Otsuka Investigational Site
city: Portsmouth
country: United Kingdom
facility: Otsuka Investigational Site
city: Preston
country: United Kingdom
facility: Otsuka Investigational Site
city: Salford
country: United Kingdom
facility: Otsuka Investigational Site
city: Sheffield
country: United Kingdom
facility: Otsuka Investigational Site
city: Southampton
country: United Kingdom
facility: Otsuka Investigational Site
city: Stevenage
country: United Kingdom
facility: Otsuka Investigational Site
city: Westcliff-on-Sea
country: United Kingdom
facility: Otsuka Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Otsuka Investigational Site
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Frank Czerwiec, MD, PhD
role: STUDY_DIRECTOR
References: