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Trial record 1 of 1 for:    NCT02100514
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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-LL)

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ClinicalTrials.gov Identifier: NCT02100514
Recruitment Status : Completed
First Posted : April 1, 2014
Results First Posted : July 21, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 27, 2014
First Posted Date  ICMJE April 1, 2014
Results First Submitted Date  ICMJE June 23, 2017
Results First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 31, 2018
Actual Study Start Date  ICMJE October 28, 2014
Actual Primary Completion Date July 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Percent Change from Baseline in fasting LDL-C at week 12. [ Time Frame: Week 12 ]
Fasting Low Density Lipoprotein Cholesterol (LDL-C)
Change History Complete list of historical versions of study NCT02100514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
  • Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period [ Time Frame: Baseline, Week 24, 52 ]
  • Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  • Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  • Plasma Concentration Versus Time Summary of PF-04950615 [ Time Frame: Week 12, 24, 52 ]
  • Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline up to end of study (up to 110 weeks) ]
    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. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.
  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period [ Time Frame: Baseline up to Week 58 ]
    Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.
  • Number of Participants Who Changed Concomitant Medication During Extension Period [ Time Frame: Week 58 follow-up to Week 110 ]
    In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.
  • Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period [ Time Frame: Baseline, Week 58 (follow up), 71, 84, 97, 110 ]
  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period [ Time Frame: Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110 ]
    Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • Change from baseline in fasting Lipid Parameters at Week 12. [ Time Frame: week 12 ]
    Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Change from baseline in fasting Lipid Parameters at Week 24. [ Time Frame: week 24 ]
    Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Change from baseline in fasting Lipid Parameters at Week 52. [ Time Frame: week 52 ]
    Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 12. [ Time Frame: week 12 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 12
  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 24. [ Time Frame: week 24 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 24.
  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 52. [ Time Frame: week 52 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 52
  • Plasma PF-04950615 concentration at week 12. [ Time Frame: week 12 ]
    Plasma PF-04950615 concentration at week 12
  • Plasma PF-04950615 concentration at week 24. [ Time Frame: week 24 ]
    Plasma PF-04950615 concentration at week 24
  • Plasma PF-04950615 concentration at week 52. [ Time Frame: week 52 ]
    Plasma PF-04950615 concentration at week 52
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Official Title  ICMJE A 52 Week 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
Brief Summary This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Drug: Bococizumab (PF-04950615; RN316)
    150 mg every 2 weeks, subcutaneous injection for 52 weeks.
  • Other: Placebo
    Subcutaneous injection every 2 weeks for 52 weeks.
Study Arms  ICMJE
  • Experimental: Bococizumab (PF-04950615; RN316)
    Bococizumab (PF-04950615; RN316)
    Intervention: Drug: Bococizumab (PF-04950615; RN316)
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2018)
746
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
939
Actual Study Completion Date  ICMJE July 10, 2017
Actual Primary Completion Date July 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treated with a statin
  • Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL
  • High or very high risk of incurring a cardiovascular event

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Congestive heart failure NYHA class IV
  • Poorly controlled hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Finland,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Puerto Rico,   Singapore,   Sweden,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02100514
Other Study ID Numbers  ICMJE B1481045
SPIRE-LL ( Other Identifier: Alias Study Number )
2014-000478-20 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP