Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01968954
Registration number
NCT01968954
Ethics application status
Date submitted
21/10/2013
Date registered
24/10/2013
Date last updated
17/05/2017
Titles & IDs
Public title
Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Query!
Scientific title
A Phase 3 Double-blind,Randomized, Placebo-controlled,Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Query!
Secondary ID [1]
0
0
2013-002642-37
Query!
Secondary ID [2]
0
0
B1481019
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPIRE-HR
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Other metabolic disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Bococizumab (PF-04950615;RN316)
Other interventions - Placebo
Experimental: Bococizumab (PF-04950615;RN316) -
Placebo comparator: Placebo -
Treatment: Drugs: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Other interventions: Placebo
subcutaneous injection, every 2 weeks for 12 months
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline, Week 12
Query!
Secondary outcome [1]
0
0
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [2]
0
0
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [4]
0
0
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [5]
0
0
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [6]
0
0
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia
Query!
Assessment method [6]
0
0
Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (\<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre \[mmol/L\]) at pre-randomization.
Query!
Timepoint [6]
0
0
Baseline, Week 12
Query!
Secondary outcome [7]
0
0
Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia
Query!
Assessment method [7]
0
0
Participants with mixed dyslipidemia are defined as TG level greater than or equal to (\>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
Query!
Timepoint [7]
0
0
Baseline, Week 12
Query!
Secondary outcome [8]
0
0
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Baseline, Week 24, 52
Query!
Secondary outcome [9]
0
0
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off
Query!
Assessment method [9]
0
0
Percent change from baseline in fasting LDL-C among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Query!
Timepoint [9]
0
0
Baseline, Week 24, 52
Query!
Secondary outcome [10]
0
0
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [11]
0
0
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [12]
0
0
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Query!
Assessment method [12]
0
0
Query!
Timepoint [12]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [13]
0
0
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [14]
0
0
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Query!
Assessment method [14]
0
0
Absolute change from baseline among participants with TG cut-off of \<200 mg/dL and \>=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.
Query!
Timepoint [14]
0
0
Baseline, Week 12
Query!
Secondary outcome [15]
0
0
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Query!
Assessment method [15]
0
0
Query!
Timepoint [15]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [16]
0
0
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Query!
Assessment method [16]
0
0
Query!
Timepoint [16]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [17]
0
0
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Query!
Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [18]
0
0
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Query!
Assessment method [18]
0
0
Query!
Timepoint [18]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [19]
0
0
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Query!
Assessment method [19]
0
0
Query!
Timepoint [19]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [20]
0
0
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Query!
Assessment method [20]
0
0
Query!
Timepoint [20]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [21]
0
0
Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [22]
0
0
Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Baseline, Week 12, 24, 52
Query!
Secondary outcome [23]
0
0
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Week 12, 24 and 52
Query!
Secondary outcome [24]
0
0
Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52
Query!
Assessment method [24]
0
0
Query!
Timepoint [24]
0
0
Week 12, 24 and 52
Query!
Secondary outcome [25]
0
0
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Query!
Assessment method [25]
0
0
Query!
Timepoint [25]
0
0
Week 12, 24, 52
Query!
Secondary outcome [26]
0
0
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Query!
Assessment method [26]
0
0
Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
Query!
Timepoint [26]
0
0
Baseline up to the end of study (up to 58 weeks)
Query!
Secondary outcome [27]
0
0
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Query!
Assessment method [27]
0
0
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer \>=6.23 were considered to be ADA positive and participants with their nAb titer \>=1.58 were considered to be nAb positive.
Query!
Timepoint [27]
0
0
Baseline up to the end of study (up to 58 weeks)
Query!
Eligibility
Key inclusion criteria
* Treated with a statin.
* Fasting LDL-C > 70 mg/dL and triglyceride <=400 mg/dL.
* High or very high risk of incurring a cardiovascular event.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Pregnant or breastfeeding females.
* Cardiovascular or cerebrovascular event of procedures during the past 30 days.
* Congestive heart failure NYHA class IV.
* Poorly controlled hypertension.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2013
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
711
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Australian Clinical Research Network - Maroubra
Query!
Recruitment hospital [2]
0
0
Core Research Group Pty Ltd - Milton
Query!
Recruitment hospital [3]
0
0
The Avenue Cardiovascular Centre - St. Kilda East
Query!
Recruitment postcode(s) [1]
0
0
2035 - Maroubra
Query!
Recruitment postcode(s) [2]
0
0
4064 - Milton
Query!
Recruitment postcode(s) [3]
0
0
3183 - St. Kilda East
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Massachusetts
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Montana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oklahoma
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Oregon
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Pennsylvania
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Tennessee
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Utah
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Virginia
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Washington
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Quebec
Query!
Country [26]
0
0
Czech Republic
Query!
State/province [26]
0
0
Hradec Kralove
Query!
Country [27]
0
0
Czech Republic
Query!
State/province [27]
0
0
Praha 5
Query!
Country [28]
0
0
Czech Republic
Query!
State/province [28]
0
0
Zlin
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Berlin
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hannover
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Ludwigshafen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Schwerin
Query!
Country [33]
0
0
Hong Kong
Query!
State/province [33]
0
0
Shatin, NT
Query!
Country [34]
0
0
Hong Kong
Query!
State/province [34]
0
0
Shatin
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
MI
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
PA
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
RM
Query!
Country [38]
0
0
Korea, Republic of
Query!
State/province [38]
0
0
Gyeonggi-do
Query!
Country [39]
0
0
Korea, Republic of
Query!
State/province [39]
0
0
Gangwon-Do
Query!
Country [40]
0
0
Korea, Republic of
Query!
State/province [40]
0
0
Gwangju
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Seoul
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Suwon
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Ulsan
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Mazowieckie
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Slaskie
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Gdynia
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Lodz
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Opole
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Oswiecim
Query!
Country [50]
0
0
Poland
Query!
State/province [50]
0
0
Poznan
Query!
Country [51]
0
0
Poland
Query!
State/province [51]
0
0
Skierniewice
Query!
Country [52]
0
0
Poland
Query!
State/province [52]
0
0
Sopot
Query!
Country [53]
0
0
Poland
Query!
State/province [53]
0
0
Warszawa
Query!
Country [54]
0
0
Poland
Query!
State/province [54]
0
0
Wroclaw
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01968954
Query!
Trial related presentations / publications
Chasman DI, Hyde CL, Giulianini F, Danning RD, Wang EQ, Hickling T, Ridker PM, Loomis AK. Genome-wide pharmacogenetics of anti-drug antibody response to bococizumab highlights key residues in HLA DRB1 and DQB1. Sci Rep. 2022 Mar 11;12(1):4266. doi: 10.1038/s41598-022-07997-5. Wang EQ, Bukowski JF, Yunis C, Shear CL, Ridker PM, Schwartz PF, Baltrukonis D. Assessing the Potential Risk of Cross-Reactivity Between Anti-Bococizumab Antibodies and Other Anti-PCSK9 Monoclonal Antibodies. BioDrugs. 2019 Oct;33(5):571-579. doi: 10.1007/s40259-019-00375-0. Ridker PM, Rose LM, Kastelein JJP, Santos RD, Wei C, Revkin J, Yunis C, Tardif JC, Shear CL; Studies of PCSK9 Inhibition and the Reduction of vascular Events (SPIRE) Investigators. Cardiovascular event reduction with PCSK9 inhibition among 1578 patients with familial hypercholesterolemia: Results from the SPIRE randomized trials of bococizumab. J Clin Lipidol. 2018 Jul-Aug;12(4):958-965. doi: 10.1016/j.jacl.2018.03.088. Epub 2018 Apr 3. Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT01968954
Download to PDF