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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/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
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
Secondary ID [1] 0 0
2013-002642-37
Secondary ID [2] 0 0
B1481019
Universal Trial Number (UTN)
Trial acronym
SPIRE-HR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperlipidemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Timepoint [1] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [2] 0 0
Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52
Timepoint [2] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [3] 0 0
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Timepoint [3] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [4] 0 0
Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Timepoint [4] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [5] 0 0
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Timepoint [5] 0 0
Baseline, Week 12, 24, 52
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
Timepoint [6] 0 0
Baseline, Week 12
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
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52
Timepoint [8] 0 0
Baseline, Week 24, 52
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
Timepoint [9] 0 0
Baseline, Week 24, 52
Secondary outcome [10] 0 0
Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52
Timepoint [10] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [11] 0 0
Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52
Timepoint [11] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [12] 0 0
Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52
Timepoint [12] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [13] 0 0
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52
Timepoint [13] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [14] 0 0
Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off
Timepoint [14] 0 0
Baseline, Week 12
Secondary outcome [15] 0 0
Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52
Timepoint [15] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [16] 0 0
Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52
Timepoint [16] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [17] 0 0
Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52
Timepoint [17] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [18] 0 0
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52
Timepoint [18] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [19] 0 0
Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52
Timepoint [19] 0 0
Baseline, Week 12, 24, 52
Secondary outcome [20] 0 0
Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52
Timepoint [20] 0 0
Baseline, Week 12, 24, 52
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
Timepoint [21] 0 0
Baseline, Week 12, 24, 52
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
Timepoint [22] 0 0
Baseline, Week 12, 24, 52
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
Timepoint [23] 0 0
Week 12, 24 and 52
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
Timepoint [24] 0 0
Week 12, 24 and 52
Secondary outcome [25] 0 0
Plasma PF-04950615 Concentrations at Week 12, 24 and 52
Timepoint [25] 0 0
Week 12, 24, 52
Secondary outcome [26] 0 0
Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions
Timepoint [26] 0 0
Baseline up to the end of study (up to 58 weeks)
Secondary outcome [27] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Timepoint [27] 0 0
Baseline up to the end of study (up to 58 weeks)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
711
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Australian Clinical Research Network - Maroubra
Recruitment hospital [2] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [3] 0 0
The Avenue Cardiovascular Centre - St. Kilda East
Recruitment postcode(s) [1] 0 0
2035 - Maroubra
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
3183 - St. Kilda East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Montana
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Praha 5
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Zlin
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Ludwigshafen
Country [32] 0 0
Germany
State/province [32] 0 0
Schwerin
Country [33] 0 0
Hong Kong
State/province [33] 0 0
Shatin, NT
Country [34] 0 0
Hong Kong
State/province [34] 0 0
Shatin
Country [35] 0 0
Italy
State/province [35] 0 0
MI
Country [36] 0 0
Italy
State/province [36] 0 0
PA
Country [37] 0 0
Italy
State/province [37] 0 0
RM
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Gyeonggi-do
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Gangwon-Do
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gwangju
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Suwon
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Ulsan
Country [44] 0 0
Poland
State/province [44] 0 0
Mazowieckie
Country [45] 0 0
Poland
State/province [45] 0 0
Slaskie
Country [46] 0 0
Poland
State/province [46] 0 0
Gdynia
Country [47] 0 0
Poland
State/province [47] 0 0
Lodz
Country [48] 0 0
Poland
State/province [48] 0 0
Opole
Country [49] 0 0
Poland
State/province [49] 0 0
Oswiecim
Country [50] 0 0
Poland
State/province [50] 0 0
Poznan
Country [51] 0 0
Poland
State/province [51] 0 0
Skierniewice
Country [52] 0 0
Poland
State/province [52] 0 0
Sopot
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Poland
State/province [54] 0 0
Wroclaw

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01968954
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/NCT01968954