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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Terminated
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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Illinois
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Corrientes
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Tienen
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Parana
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PA
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PE
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PR
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RJ
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NF
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Santiago
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Bolivar
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Caldas
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Santander
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Brno
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Havirov
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Plzen
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State/province [139] 0 0
Praha 5
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Denmark
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Denmark
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Denmark
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Aarhus
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Denmark
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Herlev
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Denmark
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Herning
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Denmark
State/province [160] 0 0
Hillerod
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Denmark
State/province [161] 0 0
Hvidovre
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Denmark
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Koge
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Denmark
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Kolding
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Denmark
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Denmark
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Denmark
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Denmark
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Denmark
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Denmark
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Denmark
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Denmark
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Finland
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Finland
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Finland
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Finland
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Finland
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Finland
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Finland
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Finland
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Finland
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Siilinjarvi
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Finland
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Tampere
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Finland
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France
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Besancon
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France
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Bourg En Bresse Cedex 10000
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France
State/province [190] 0 0
Caen cedex 9
Country [191] 0 0
France
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Cannes Cedex
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France
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Corbeil-Essonnes
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France
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Essey-Les-Nancy
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France
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Le Coudray
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France
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Lille
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France
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Lomme
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France
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Lyon Cedex 03
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France
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Montpellier cedex 5
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France
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Nantes
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France
State/province [200] 0 0
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France
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Nimes
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France
State/province [202] 0 0
PAU
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France
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Pessac cedex
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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
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France
State/province [207] 0 0
Tourcoing
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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
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Germany
State/province [211] 0 0
Baden-wurttemberg
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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
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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
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Germany
State/province [226] 0 0
Dresden
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Germany
State/province [227] 0 0
Essen
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Germany
State/province [228] 0 0
Falkensee
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Germany
State/province [229] 0 0
Frankfurt am Main
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Germany
State/province [230] 0 0
Frankfurt
Country [231] 0 0
Germany
State/province [231] 0 0
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Germany
State/province [232] 0 0
Hamburg
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Germany
State/province [233] 0 0
Hannover
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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
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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
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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
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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
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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
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Netherlands
State/province [354] 0 0
Alkmaar
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Netherlands
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Almere
Country [356] 0 0
Netherlands
State/province [356] 0 0
Amersfoort
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Netherlands
State/province [357] 0 0
Amstelveen
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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
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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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York

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

Ethics approval
Ethics application status

Summary
Brief summary
This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to
placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular
death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization
in high risk subjects who are receiving background lipid lowering therapy and have
cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL
(3.4 mmol/L).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01975389
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01975389