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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01458574




Registration number
NCT01458574
Ethics application status
Date submitted
21/10/2011
Date registered
25/10/2011
Date last updated
18/05/2017

Titles & IDs
Public title
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Scientific title
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Secondary ID [1] 0 0
2011-004580-79
Secondary ID [2] 0 0
A3921096
Universal Trial Number (UTN)
Trial acronym
OCTAVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - CP690,550
Treatment: Drugs - CP-690,550

Placebo comparator: Placebo Comparator -

Experimental: CP-690,550 5 mg Arm -

Experimental: CP-690,550 10 mg Arm -


Treatment: Drugs: Placebo
Placebo 10 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)

Treatment: Drugs: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants In Remission at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Percentage of Participants With Mucosal Healing at Week 52
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Timepoint [2] 0 0
Week 24, 52
Secondary outcome [3] 0 0
Percentage of Participants in Remission at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percentage of Participants in Sustained Remission
Timepoint [4] 0 0
Week 24, 52
Secondary outcome [5] 0 0
Percentage of Participants With Mucosal Healing at Week 24
Timepoint [5] 0 0
Week 24
Secondary outcome [6] 0 0
Percentage of Participants With Sustained Mucosal Healing
Timepoint [6] 0 0
Week 24, 52
Secondary outcome [7] 0 0
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Timepoint [7] 0 0
Week 24, 52
Secondary outcome [8] 0 0
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Timepoint [8] 0 0
Week 24, 52
Secondary outcome [9] 0 0
Percentage of Participants With Clinical Response at Week 24 and 52
Timepoint [9] 0 0
Week 24, 52
Secondary outcome [10] 0 0
Percentage of Participants With Sustained Clinical Response
Timepoint [10] 0 0
Week 24, 52
Secondary outcome [11] 0 0
Percentage of Participants in Clinical Remission at Week 24 and 52
Timepoint [11] 0 0
Week 24, 52
Secondary outcome [12] 0 0
Percentage of Participants in Sustained Clinical Remission
Timepoint [12] 0 0
Week 24, 52
Secondary outcome [13] 0 0
Percentage of Participants in Deep Remission at Week 24 and 52
Timepoint [13] 0 0
Week 24, 52
Secondary outcome [14] 0 0
Percentage of Participants in Sustained Deep Remission
Timepoint [14] 0 0
Week 24, 52
Secondary outcome [15] 0 0
Percentage of Participants in Symptomatic Remission at Week 24 and 52
Timepoint [15] 0 0
Week 24, 52
Secondary outcome [16] 0 0
Percentage of Participants in Sustained Symptomatic Remission
Timepoint [16] 0 0
Week 24, 52
Secondary outcome [17] 0 0
Percentage of Participants in Endoscopic Remission at Week 24 and 52
Timepoint [17] 0 0
Week 24, 52
Secondary outcome [18] 0 0
Percentage of Participants in Sustained Endoscopic Remission
Timepoint [18] 0 0
Week 24, 52
Secondary outcome [19] 0 0
Total Mayo Score at Baseline, Week 24 and 52
Timepoint [19] 0 0
Baseline, Week 24, 52
Secondary outcome [20] 0 0
Change From Baseline in Total Mayo Score at Week 24 and 52
Timepoint [20] 0 0
Baseline, Week 24, 52
Secondary outcome [21] 0 0
Percentage of Participants in Remission, Among Participants With Remission at Baseline
Timepoint [21] 0 0
Week 24, 52
Secondary outcome [22] 0 0
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Timepoint [22] 0 0
Week 24, 52
Secondary outcome [23] 0 0
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Timepoint [23] 0 0
Week 24, 52
Secondary outcome [24] 0 0
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Timepoint [24] 0 0
Week 24, 52
Secondary outcome [25] 0 0
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Timepoint [25] 0 0
Week 24, 52

Eligibility
Key inclusion criteria
* Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
* Subjects who achieved clinical response in Study A3921094 or A3921095
* Women of childbearing potential must test negative for pregnancy prior to study enrollment
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
* Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2016
Sample size
Target
Accrual to date
Final
593
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
New Hampshire
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Utah
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
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Belgium
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Antwerpen
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Roeselare
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Brazil
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Rio Grande Do Sul
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Alberta
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Ontario
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Quebec
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Canada
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Saskatchewan
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Colombia
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Antioquia
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Croatia
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Zagreb
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Czech Republic
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Hradec Kralove
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Czech Republic
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Strakonice
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Czech Republic
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Usti nad Labem
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Aalborg
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Aarhus C
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Denmark
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Copenhagen NV
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Hvidovre
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Denmark
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Odense C
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Estonia
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Tallinn
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Estonia
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Tallin
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France
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Amiens Cedex 1
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France
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Bordeaux cedex
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France
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Clichy Cedex
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France
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Nantes cedex 01
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France
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Paris cedex 12
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France
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Paris
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France
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Reims cedex
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France
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Saint Priest en Jarez
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Germany
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Schlewig Holstein
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Germany
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Berlin
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Germany
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Halle
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Germany
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Hannover
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Germany
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Lüneburg
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Germany
State/province [55] 0 0
Minden
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Germany
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Ulm
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Debrecen
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Gyula
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Miskolc
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Mosonmagyarovar
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Hungary
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Pecs
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Szeged
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Vac
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Haifa
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Petah Tikva
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Israel
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Rehovot
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Italy
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Milano
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Italy
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PA
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Italy
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Catanzaro
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Aichi
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Ibaraki
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Kochi
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Miyagi
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Osaka
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Shiga
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Chiba
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Fukuoka
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Republic of Korea
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Netherlands
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Amsterdam
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Groningen
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Netherlands
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Auckland
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Bay of Plenty
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New Zealand
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Canterbury Region
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New Zealand
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Dunedin
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Hamilton
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New Zealand
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Wellington
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Poland
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Iodzkie
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Kujawsko-pomorskie
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Mazowieckie
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Poland
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Slaskie
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Bydgoszcz
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Krakow
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Lodz
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Sopot
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Warszawa
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Wroclaw
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Romania
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Timis
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Romania
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Bucuresti
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Russian Federation
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Russia
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk,
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Russian Federation
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Novosibirsk
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Russian Federation
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Samara
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Russian Federation
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Yaroslavl
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Serbia
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Serbia, Europe
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Serbia
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Zrenjanin
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Nove Mesto nad Vahom
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Slovakia
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Presov
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South Africa
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Cape Town
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Gauteng
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Spain
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Taipei City
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Ukraine
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Ar Krym
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Ukraine
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Chernivtsi
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Ukraine
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Dniepropetrovsk
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odesa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Cambridgeshire
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England
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United Kingdom
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Greater London
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Middlesex
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United Kingdom
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Norfolk
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United Kingdom
State/province [148] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01458574