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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-LDL)

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ClinicalTrials.gov Identifier: NCT01968967
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : July 24, 2017
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

October 21, 2013
October 24, 2013
June 22, 2017
July 24, 2017
February 13, 2018
October 29, 2013
July 5, 2016   (Final data collection date for primary outcome measure)
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ]
Low Density Lipoprotein Cholesterol (LDL-C)
Complete list of historical versions of study NCT01968967 on ClinicalTrials.gov Archive Site
  • 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 (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 (TG) 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 and 52 [ 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 (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 ]
  • 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 of PF-04950615 at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
    Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.
  • Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline up to end of study (up to Week 58) ]
    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) [ Time Frame: Baseline up to end of study (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 was considered to be ADA positive and nAb titer >=1.58 was considered to be nAb positive.
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ]
    Percent change in 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 Lipid Parameters at Week 24 [ Time Frame: 24 weeks ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, and ApoA-II blood concentrations.
  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ]
    Low Density Lipoprotein (LDL), Mean Total Cholesterol (TC), 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 [ Time Frame: 12 weeks ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 24 weeks ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL [ Time Frame: 52 weeks ]
    Proportion of Subjects Achieving Fasting LDL-C <= 100 mg/dL and <=70 mg/dL
  • Plasma PF-04950615 concentration [ Time Frame: 12 weeks ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 24 weeks ]
    Plasma PF-04950615 concentration
  • Plasma PF-04950615 concentration [ Time Frame: 52 weeks ]
    Plasma PF-04950615 concentration
Not Provided
Not Provided
 
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events
A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Drug: Bococizumab (PF-04950615; RN316)
    150 mg every 2 weeks, subcutaneous injection, 12 months
  • Other: Placebo
    subcutaneous injection every 2 weeks for 12 months
  • Experimental: Bococizumab (PF-04950615; RN316)
    Intervention: Drug: Bococizumab (PF-04950615; RN316)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2140
1600
July 10, 2017
July 5, 2016   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Colombia,   France,   Hungary,   Lithuania,   Mexico,   Romania,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
 
 
NCT01968967
B1481020
2013-002643-28 ( EudraCT Number )
SPIRE-LDL ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2018

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