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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01975389




Registration number
NCT01975389
Ethics application status
Date submitted
21/10/2013
Date registered
3/11/2013
Date last updated
1/05/2019

Titles & IDs
Public title
The Evaluation of Bococizumab (PF-04950615; RN316) in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects
Scientific title
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Secondary ID [1] 0 0
CV OUTCOMES 2
Secondary ID [2] 0 0
B1481038
Universal Trial Number (UTN)
Trial acronym
SPIRE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bococizumab (PF-04950615)
Treatment: Drugs - Placebo

Experimental: bococizumab (PF-04950615) - 150 mg, every 2 weeks, subcutaneous.

Placebo comparator: Placebo - Placebo comparator, every 2 weeks, subcutaneous.


Treatment: Drugs: bococizumab (PF-04950615)
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

Treatment: Drugs: Placebo
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event
Timepoint [1] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)
Secondary outcome [1] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke
Timepoint [1] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)
Secondary outcome [2] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization
Timepoint [2] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)
Secondary outcome [3] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke
Timepoint [3] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)
Secondary outcome [4] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization
Timepoint [4] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)
Secondary outcome [5] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina
Timepoint [5] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)
Secondary outcome [6] 0 0
Event Rate Per 100 Participant-years for Cardiovascular (CV) Death
Timepoint [6] 0 0
From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)
Secondary outcome [7] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)
Timepoint [7] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years)
Secondary outcome [8] 0 0
Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)
Timepoint [8] 0 0
From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)
Secondary outcome [9] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)
Timepoint [9] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)
Secondary outcome [10] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)
Timepoint [10] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)
Secondary outcome [11] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology
Timepoint [11] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)
Secondary outcome [12] 0 0
Event Rate Per 100 Participant-years for Fatal Stroke
Timepoint [12] 0 0
From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)
Secondary outcome [13] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke
Timepoint [13] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)
Secondary outcome [14] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina
Timepoint [14] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)
Secondary outcome [15] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)
Timepoint [15] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)
Secondary outcome [16] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization
Timepoint [16] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)
Secondary outcome [17] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)
Timepoint [17] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)
Secondary outcome [18] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)
Timepoint [18] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)
Secondary outcome [19] 0 0
Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations
Timepoint [19] 0 0
From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)
Secondary outcome [20] 0 0
Event Rate Per 100 Participant-years for All-cause Death
Timepoint [20] 0 0
From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)
Secondary outcome [21] 0 0
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
Timepoint [21] 0 0
Baseline, Week 14
Secondary outcome [22] 0 0
Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
Timepoint [22] 0 0
Baseline, Week 14
Secondary outcome [23] 0 0
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement
Timepoint [23] 0 0
Baseline, last post-baseline measurement (any time up to Week 140)
Secondary outcome [24] 0 0
Percent Change From Baseline in Lipid Levels at Week 14
Timepoint [24] 0 0
Baseline, Week 14
Secondary outcome [25] 0 0
Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14
Timepoint [25] 0 0
Baseline, Week 14
Secondary outcome [26] 0 0
Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14
Timepoint [26] 0 0
Baseline, Week 14

Eligibility
Key inclusion criteria
* Must be on background lipid lowering treatment.
* Must be at high risk of a CV event.
* Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Planned coronary (PCI or CABG) or other arterial revascularization.
* New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging.
* Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis.
* History of hemorrhagic stroke.
* Prior exposure to bococizumab or other investigational PCSK9 inhibitor.

Study design
Purpose of the study
Prevention
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 administering the treatment/s
The people assessing the outcomes
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/04/2017
Sample size
Target
Accrual to date
Final
10564
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Boden Institute of Obesity, Nutrition, Exercise and Eating Disorders - Camperdown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Central Coast Neurosciences Research - Erina
Recruitment hospital [4] 0 0
Central Coast Local Health District, Gosford Hospital - Gosford
Recruitment hospital [5] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [6] 0 0
Holy Spirit Northside Private Hospital Limited - Chermside
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [9] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [10] 0 0
Austrials Pty Ltd - Sherwood
Recruitment hospital [11] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [12] 0 0
Adelaide Medical Research - Ashford
Recruitment hospital [13] 0 0
SA Heart - Ashford
Recruitment hospital [14] 0 0
Southern Adelaide Diabetes and Endocrine Service - Daws Park
Recruitment hospital [15] 0 0
Department of Cardiology, Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [16] 0 0
Heart and Vascular Research - Fullarton
Recruitment hospital [17] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [18] 0 0
Eastern Health - Box Hill Hospital - Box Hill
Recruitment hospital [19] 0 0
The Northern Hospital - Epping
Recruitment hospital [20] 0 0
Barwon Health-The Geelong Hospital - Geelong
Recruitment hospital [21] 0 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [22] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [23] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [24] 0 0
HPS Pharmacies - Joondalup
Recruitment hospital [25] 0 0
Joondalup Cardiovascular Trials Foundation Inc. - Joondalup
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2250 - Erina
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2035 - Maroubra
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
4020 - Redcliffe
Recruitment postcode(s) [9] 0 0
4075 - Sherwood
Recruitment postcode(s) [10] 0 0
4215 - Southport
Recruitment postcode(s) [11] 0 0
5035 - Ashford
Recruitment postcode(s) [12] 0 0
5041 - Daws Park
Recruitment postcode(s) [13] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [14] 0 0
5063 - Fullarton
Recruitment postcode(s) [15] 0 0
7250 - Launceston
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3076 - Epping
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment postcode(s) [19] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [20] 0 0
3004 - Melbourne
Recruitment postcode(s) [21] 0 0
6160 - Fremantle
Recruitment postcode(s) [22] 0 0
6027 - Joondalup
Recruitment outside Australia
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Alabama
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Alaska
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Georgia
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Hawaii
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Idaho
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Illinois
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Argentina
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Corrientes
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Salta
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Tienen
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BA
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CE
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Brazil
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Indiana
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Parana
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PA
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Pernambuco
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PE
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PR
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Brazil
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RJ
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SP
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Manitoba
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NF
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Ontario
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Chile
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Santiago
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Bolivar
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Caldas
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Cundinamarca
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Santander
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Valle DEL Cauca
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Czech Republic
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Kralovehradecky KRAJ
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Brno
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Havirov
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Hradec Kralove
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Litovel
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Pardubice
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Plzen
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Praha 2
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Czechia
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Czechia
State/province [139] 0 0
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Czechia
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Czechia
State/province [141] 0 0
Praha
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Czechia
State/province [142] 0 0
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Czechia
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Czechia
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Czechia
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Czechia
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Uherske Hradiste
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Czechia
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Denmark
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Denmark
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Denmark
State/province [150] 0 0
Aarhus N
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Denmark
State/province [151] 0 0
Aarhus
Country [152] 0 0
Denmark
State/province [152] 0 0
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Denmark
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Copenhagen NV
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Denmark
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Copenhagen Oe
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Denmark
State/province [155] 0 0
Esbjerg
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Denmark
State/province [156] 0 0
Frederiksberg
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Denmark
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Glostrup
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Denmark
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Herlev
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Denmark
State/province [159] 0 0
Herning
Country [160] 0 0
Denmark
State/province [160] 0 0
Hillerod
Country [161] 0 0
Denmark
State/province [161] 0 0
Hvidovre
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Denmark
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Kobenhavn S.
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Denmark
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Koge
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Denmark
State/province [164] 0 0
Kolding
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Denmark
State/province [165] 0 0
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Denmark
State/province [166] 0 0
Nykobing F.
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Denmark
State/province [167] 0 0
Randers
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Denmark
State/province [168] 0 0
Silkeborg
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Denmark
State/province [169] 0 0
Slagelse
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Denmark
State/province [170] 0 0
Svendborg
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Denmark
State/province [171] 0 0
Vejle
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Denmark
State/province [172] 0 0
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Finland
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Hameenlinna
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Finland
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Helsinki
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Finland
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Finland
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Jyvaskyla
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Finland
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Kerava
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Finland
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Kinkomaa
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Finland
State/province [179] 0 0
Kokkola
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Finland
State/province [180] 0 0
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Finland
State/province [181] 0 0
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Finland
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Oulu
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Finland
State/province [183] 0 0
Pori
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Finland
State/province [184] 0 0
Siilinjarvi
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Finland
State/province [185] 0 0
Tampere
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Finland
State/province [186] 0 0
Turku
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Finland
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Vantaa
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France
State/province [188] 0 0
Besancon
Country [189] 0 0
France
State/province [189] 0 0
Bourg En Bresse Cedex 10000
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France
State/province [190] 0 0
Caen cedex 9
Country [191] 0 0
France
State/province [191] 0 0
Cannes Cedex
Country [192] 0 0
France
State/province [192] 0 0
Corbeil-Essonnes
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France
State/province [193] 0 0
Essey-Les-Nancy
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France
State/province [194] 0 0
Le Coudray
Country [195] 0 0
France
State/province [195] 0 0
Lille
Country [196] 0 0
France
State/province [196] 0 0
Lomme
Country [197] 0 0
France
State/province [197] 0 0
Lyon Cedex 03
Country [198] 0 0
France
State/province [198] 0 0
Montpellier cedex 5
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France
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Nantes
Country [200] 0 0
France
State/province [200] 0 0
Nimes cedex 9
Country [201] 0 0
France
State/province [201] 0 0
Nimes
Country [202] 0 0
France
State/province [202] 0 0
PAU
Country [203] 0 0
France
State/province [203] 0 0
Pessac cedex
Country [204] 0 0
France
State/province [204] 0 0
Poitiers cedex
Country [205] 0 0
France
State/province [205] 0 0
Rennes Cedex 9
Country [206] 0 0
France
State/province [206] 0 0
Toulouse cedex 9
Country [207] 0 0
France
State/province [207] 0 0
Tourcoing
Country [208] 0 0
France
State/province [208] 0 0
Tours Cedex 9
Country [209] 0 0
France
State/province [209] 0 0
Valenciennes
Country [210] 0 0
Germany
State/province [210] 0 0
Baden-wuerttemberg
Country [211] 0 0
Germany
State/province [211] 0 0
Baden-wurttemberg
Country [212] 0 0
Germany
State/province [212] 0 0
Hessen
Country [213] 0 0
Germany
State/province [213] 0 0
Mecklenburg-vorpommern
Country [214] 0 0
Germany
State/province [214] 0 0
Rheinland Pfalz
Country [215] 0 0
Germany
State/province [215] 0 0
Rhineland-palatinate
Country [216] 0 0
Germany
State/province [216] 0 0
Altenburg
Country [217] 0 0
Germany
State/province [217] 0 0
Bad Berka
Country [218] 0 0
Germany
State/province [218] 0 0
Bad Homburg
Country [219] 0 0
Germany
State/province [219] 0 0
Berlin
Country [220] 0 0
Germany
State/province [220] 0 0
Bielefeld
Country [221] 0 0
Germany
State/province [221] 0 0
Bochum
Country [222] 0 0
Germany
State/province [222] 0 0
Burg-Spreewald
Country [223] 0 0
Germany
State/province [223] 0 0
Coburg
Country [224] 0 0
Germany
State/province [224] 0 0
Dachau
Country [225] 0 0
Germany
State/province [225] 0 0
Dortmund
Country [226] 0 0
Germany
State/province [226] 0 0
Dresden
Country [227] 0 0
Germany
State/province [227] 0 0
Essen
Country [228] 0 0
Germany
State/province [228] 0 0
Falkensee
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Germany
State/province [229] 0 0
Frankfurt am Main
Country [230] 0 0
Germany
State/province [230] 0 0
Frankfurt
Country [231] 0 0
Germany
State/province [231] 0 0
Greifswald
Country [232] 0 0
Germany
State/province [232] 0 0
Hamburg
Country [233] 0 0
Germany
State/province [233] 0 0
Hannover
Country [234] 0 0
Germany
State/province [234] 0 0
Homburgsaar
Country [235] 0 0
Germany
State/province [235] 0 0
Kamp-Lintfort
Country [236] 0 0
Germany
State/province [236] 0 0
Kassel
Country [237] 0 0
Germany
State/province [237] 0 0
Koeln
Country [238] 0 0
Germany
State/province [238] 0 0
Kuenzing
Country [239] 0 0
Germany
State/province [239] 0 0
Lahr
Country [240] 0 0
Germany
State/province [240] 0 0
Leipzig
Country [241] 0 0
Germany
State/province [241] 0 0
Luedenscheid
Country [242] 0 0
Germany
State/province [242] 0 0
Lunen
Country [243] 0 0
Germany
State/province [243] 0 0
Magdeburg
Country [244] 0 0
Germany
State/province [244] 0 0
Mainz
Country [245] 0 0
Germany
State/province [245] 0 0
Muenchen
Country [246] 0 0
Germany
State/province [246] 0 0
Munchen
Country [247] 0 0
Germany
State/province [247] 0 0
Munich
Country [248] 0 0
Germany
State/province [248] 0 0
Northeim
Country [249] 0 0
Germany
State/province [249] 0 0
Nurnberg
Country [250] 0 0
Germany
State/province [250] 0 0
Offenbach
Country [251] 0 0
Germany
State/province [251] 0 0
Rodgau
Country [252] 0 0
Germany
State/province [252] 0 0
Rudersdorf
Country [253] 0 0
Germany
State/province [253] 0 0
Soest
Country [254] 0 0
Germany
State/province [254] 0 0
Stuhr-Brinkum
Country [255] 0 0
Germany
State/province [255] 0 0
Stuttgart
Country [256] 0 0
Germany
State/province [256] 0 0
Warendorf
Country [257] 0 0
Germany
State/province [257] 0 0
Wermsdorf
Country [258] 0 0
Germany
State/province [258] 0 0
Witten
Country [259] 0 0
Hungary
State/province [259] 0 0
Bacs-kiskun
Country [260] 0 0
Hungary
State/province [260] 0 0
Baranya
Country [261] 0 0
Hungary
State/province [261] 0 0
Csongrad
Country [262] 0 0
Hungary
State/province [262] 0 0
Fejer
Country [263] 0 0
Hungary
State/province [263] 0 0
Balatonfured
Country [264] 0 0
Hungary
State/province [264] 0 0
Balatongyorok
Country [265] 0 0
Hungary
State/province [265] 0 0
Bekescsaba
Country [266] 0 0
Hungary
State/province [266] 0 0
Berettyoujfalu
Country [267] 0 0
Hungary
State/province [267] 0 0
Budapest
Country [268] 0 0
Hungary
State/province [268] 0 0
Debrecen
Country [269] 0 0
Hungary
State/province [269] 0 0
Gyula
Country [270] 0 0
Hungary
State/province [270] 0 0
Hajduszoboszlo
Country [271] 0 0
Hungary
State/province [271] 0 0
Hatvan
Country [272] 0 0
Hungary
State/province [272] 0 0
Kaposvar
Country [273] 0 0
Hungary
State/province [273] 0 0
Kecskemet
Country [274] 0 0
Hungary
State/province [274] 0 0
Kistarcsa
Country [275] 0 0
Hungary
State/province [275] 0 0
Nyiregyhaza
Country [276] 0 0
Hungary
State/province [276] 0 0
Pecs
Country [277] 0 0
Hungary
State/province [277] 0 0
Szekesfehervar
Country [278] 0 0
Hungary
State/province [278] 0 0
Szolnok
Country [279] 0 0
Hungary
State/province [279] 0 0
Szombathely
Country [280] 0 0
Hungary
State/province [280] 0 0
Veszprem
Country [281] 0 0
Hungary
State/province [281] 0 0
Zalaegerszeg
Country [282] 0 0
India
State/province [282] 0 0
Gujarat
Country [283] 0 0
India
State/province [283] 0 0
Maharashtra
Country [284] 0 0
India
State/province [284] 0 0
Uttar Pradesh
Country [285] 0 0
Ireland
State/province [285] 0 0
Leinster
Country [286] 0 0
Ireland
State/province [286] 0 0
Dublin
Country [287] 0 0
Israel
State/province [287] 0 0
Tel-aviv
Country [288] 0 0
Israel
State/province [288] 0 0
Ashkelon
Country [289] 0 0
Israel
State/province [289] 0 0
Beer Sheva
Country [290] 0 0
Israel
State/province [290] 0 0
Hadera
Country [291] 0 0
Israel
State/province [291] 0 0
Haifa
Country [292] 0 0
Israel
State/province [292] 0 0
Holon
Country [293] 0 0
Israel
State/province [293] 0 0
Jerusalem
Country [294] 0 0
Israel
State/province [294] 0 0
Kfar Sava
Country [295] 0 0
Israel
State/province [295] 0 0
Kfar-Saba
Country [296] 0 0
Israel
State/province [296] 0 0
Nahariya
Country [297] 0 0
Israel
State/province [297] 0 0
Nazareth
Country [298] 0 0
Israel
State/province [298] 0 0
Petach Tikva
Country [299] 0 0
Israel
State/province [299] 0 0
Petah Tikva
Country [300] 0 0
Israel
State/province [300] 0 0
Raanana
Country [301] 0 0
Israel
State/province [301] 0 0
Ramat Gan
Country [302] 0 0
Israel
State/province [302] 0 0
Rehovot
Country [303] 0 0
Israel
State/province [303] 0 0
Safed
Country [304] 0 0
Israel
State/province [304] 0 0
Tel Aviv
Country [305] 0 0
Israel
State/province [305] 0 0
Tel Hashomer
Country [306] 0 0
Israel
State/province [306] 0 0
Tel-Aviv
Country [307] 0 0
Italy
State/province [307] 0 0
Bergamo
Country [308] 0 0
Italy
State/province [308] 0 0
CZ
Country [309] 0 0
Italy
State/province [309] 0 0
Geneve
Country [310] 0 0
Italy
State/province [310] 0 0
Lecco
Country [311] 0 0
Italy
State/province [311] 0 0
PA
Country [312] 0 0
Italy
State/province [312] 0 0
PG
Country [313] 0 0
Italy
State/province [313] 0 0
Province OF Lecco
Country [314] 0 0
Italy
State/province [314] 0 0
RM
Country [315] 0 0
Italy
State/province [315] 0 0
Verona
Country [316] 0 0
Italy
State/province [316] 0 0
VR
Country [317] 0 0
Italy
State/province [317] 0 0
Ancona
Country [318] 0 0
Italy
State/province [318] 0 0
Belluno
Country [319] 0 0
Italy
State/province [319] 0 0
Cagliari
Country [320] 0 0
Italy
State/province [320] 0 0
Milan
Country [321] 0 0
Italy
State/province [321] 0 0
Napoli
Country [322] 0 0
Italy
State/province [322] 0 0
Reggio Emilia
Country [323] 0 0
Italy
State/province [323] 0 0
Rimini
Country [324] 0 0
Italy
State/province [324] 0 0
Rovigo
Country [325] 0 0
Italy
State/province [325] 0 0
Udine
Country [326] 0 0
Korea, Republic of
State/province [326] 0 0
Chungcheonbuk-do
Country [327] 0 0
Korea, Republic of
State/province [327] 0 0
Gangwon-do
Country [328] 0 0
Korea, Republic of
State/province [328] 0 0
Gyeongbuk
Country [329] 0 0
Korea, Republic of
State/province [329] 0 0
Gyeonggi-do
Country [330] 0 0
Korea, Republic of
State/province [330] 0 0
Busan
Country [331] 0 0
Korea, Republic of
State/province [331] 0 0
Daegu
Country [332] 0 0
Korea, Republic of
State/province [332] 0 0
Incheon
Country [333] 0 0
Korea, Republic of
State/province [333] 0 0
Seoul
Country [334] 0 0
Mexico
State/province [334] 0 0
Chihuahua
Country [335] 0 0
Mexico
State/province [335] 0 0
DF
Country [336] 0 0
Mexico
State/province [336] 0 0
Distrito Federal
Country [337] 0 0
Mexico
State/province [337] 0 0
Guerrero
Country [338] 0 0
Mexico
State/province [338] 0 0
Hidalgo
Country [339] 0 0
Mexico
State/province [339] 0 0
Jalisco
Country [340] 0 0
Mexico
State/province [340] 0 0
Morelos
Country [341] 0 0
Mexico
State/province [341] 0 0
Nuevo LEON
Country [342] 0 0
Mexico
State/province [342] 0 0
Queretaro
Country [343] 0 0
Mexico
State/province [343] 0 0
Sinaloa
Country [344] 0 0
Mexico
State/province [344] 0 0
Tamaulipas
Country [345] 0 0
Mexico
State/province [345] 0 0
Veracruz
Country [346] 0 0
Mexico
State/province [346] 0 0
Aguascalientes
Country [347] 0 0
Mexico
State/province [347] 0 0
Durango
Country [348] 0 0
Mexico
State/province [348] 0 0
Mexico
Country [349] 0 0
Mexico
State/province [349] 0 0
San Luis Potosi
Country [350] 0 0
Netherlands
State/province [350] 0 0
Friesland
Country [351] 0 0
Netherlands
State/province [351] 0 0
Limburg
Country [352] 0 0
Netherlands
State/province [352] 0 0
Overijssel
Country [353] 0 0
Netherlands
State/province [353] 0 0
Zuid-holland
Country [354] 0 0
Netherlands
State/province [354] 0 0
Alkmaar
Country [355] 0 0
Netherlands
State/province [355] 0 0
Almere
Country [356] 0 0
Netherlands
State/province [356] 0 0
Amersfoort
Country [357] 0 0
Netherlands
State/province [357] 0 0
Amstelveen
Country [358] 0 0
Netherlands
State/province [358] 0 0
Amsterdam
Country [359] 0 0
Netherlands
State/province [359] 0 0
Apeldoorn
Country [360] 0 0
Netherlands
State/province [360] 0 0
Beverwijk
Country [361] 0 0
Netherlands
State/province [361] 0 0
Blaricum
Country [362] 0 0
Netherlands
State/province [362] 0 0
Breda
Country [363] 0 0
Netherlands
State/province [363] 0 0
Delft
Country [364] 0 0
Netherlands
State/province [364] 0 0
Den Haag
Country [365] 0 0
Netherlands
State/province [365] 0 0
Deventer
Country [366] 0 0
Netherlands
State/province [366] 0 0
Dirksland
Country [367] 0 0
Netherlands
State/province [367] 0 0
Doetinchem
Country [368] 0 0
Netherlands
State/province [368] 0 0
Dordrecht
Country [369] 0 0
Netherlands
State/province [369] 0 0
Ede
Country [370] 0 0
Netherlands
State/province [370] 0 0
Eindhoven
Country [371] 0 0
Netherlands
State/province [371] 0 0
Enschede
Country [372] 0 0
Netherlands
State/province [372] 0 0
Gorinchem
Country [373] 0 0
Netherlands
State/province [373] 0 0
Gouda
Country [374] 0 0
Netherlands
State/province [374] 0 0
Groningen
Country [375] 0 0
Netherlands
State/province [375] 0 0
Haarlem
Country [376] 0 0
Netherlands
State/province [376] 0 0
Hardenberg
Country [377] 0 0
Netherlands
State/province [377] 0 0
Harderwijk
Country [378] 0 0
Netherlands
State/province [378] 0 0
Heerlen
Country [379] 0 0
Netherlands
State/province [379] 0 0
Hoogeveen
Country [380] 0 0
Netherlands
State/province [380] 0 0
Hoorn
Country [381] 0 0
Netherlands
State/province [381] 0 0
Kloosterhaar
Country [382] 0 0
Netherlands
State/province [382] 0 0
Leeuwarden
Country [383] 0 0
Netherlands
State/province [383] 0 0
Leiden
Country [384] 0 0
Netherlands
State/province [384] 0 0
Leiderdorp
Country [385] 0 0
Netherlands
State/province [385] 0 0
Maarssen
Country [386] 0 0
Netherlands
State/province [386] 0 0
Maastricht
Country [387] 0 0
Netherlands
State/province [387] 0 0
Meppel
Country [388] 0 0
Netherlands
State/province [388] 0 0
Nieuwegein
Country [389] 0 0
Netherlands
State/province [389] 0 0
Nijmegen
Country [390] 0 0
Netherlands
State/province [390] 0 0
Purmerend
Country [391] 0 0
Netherlands
State/province [391] 0 0
Rotterdam
Country [392] 0 0
Netherlands
State/province [392] 0 0
Sneek
Country [393] 0 0
Netherlands
State/province [393] 0 0
Tiel
Country [394] 0 0
Netherlands
State/province [394] 0 0
Tilburg
Country [395] 0 0
Netherlands
State/province [395] 0 0
Uden
Country [396] 0 0
Netherlands
State/province [396] 0 0
Utrecht
Country [397] 0 0
Netherlands
State/province [397] 0 0
Veldhoven
Country [398] 0 0
Netherlands
State/province [398] 0 0
Venlo
Country [399] 0 0
Netherlands
State/province [399] 0 0
Waalwijk
Country [400] 0 0
Netherlands
State/province [400] 0 0
Zoetermeer
Country [401] 0 0
Netherlands
State/province [401] 0 0
Zwijndrecht
Country [402] 0 0
New Zealand
State/province [402] 0 0
Auckland
Country [403] 0 0
New Zealand
State/province [403] 0 0
Hastings
Country [404] 0 0
New Zealand
State/province [404] 0 0
Christchurch
Country [405] 0 0
New Zealand
State/province [405] 0 0
New Plymouth
Country [406] 0 0
New Zealand
State/province [406] 0 0
Papamoa
Country [407] 0 0
New Zealand
State/province [407] 0 0
Rotorua
Country [408] 0 0
New Zealand
State/province [408] 0 0
Tauranga
Country [409] 0 0
New Zealand
State/province [409] 0 0
Wellington
Country [410] 0 0
Poland
State/province [410] 0 0
Dolnoslaskie
Country [411] 0 0
Poland
State/province [411] 0 0
Iodzkie
Country [412] 0 0
Poland
State/province [412] 0 0
Kujawsko-pomorskie
Country [413] 0 0
Poland
State/province [413] 0 0
Lodzkie
Country [414] 0 0
Poland
State/province [414] 0 0
Lubelskie
Country [415] 0 0
Poland
State/province [415] 0 0
Malopolskie
Country [416] 0 0
Poland
State/province [416] 0 0
Mazowieckie
Country [417] 0 0
Poland
State/province [417] 0 0
Podkarpackie
Country [418] 0 0
Poland
State/province [418] 0 0
Podlaskie
Country [419] 0 0
Poland
State/province [419] 0 0
Pomorskie
Country [420] 0 0
Poland
State/province [420] 0 0
Slaskie
Country [421] 0 0
Poland
State/province [421] 0 0
Swietokrzyskie
Country [422] 0 0
Poland
State/province [422] 0 0
Warminsko-mazurskie
Country [423] 0 0
Poland
State/province [423] 0 0
Wielkopolskie
Country [424] 0 0
Poland
State/province [424] 0 0
Bialystok
Country [425] 0 0
Poland
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Slovakia
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Spain
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Spain
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Spain
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Spain
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Spain
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Gerona
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Girona-catalonia
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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Spain
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York

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01975389