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Trial record 1 of 1 for:    NCT01968954
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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-HR)

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ClinicalTrials.gov Identifier: NCT01968954
Recruitment Status : Completed
First Posted : October 24, 2013
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 24, 2013
Results First Submitted Date  ICMJE April 6, 2017
Results First Posted Date  ICMJE May 17, 2017
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: 12 weeks ]
Low Density Lipoprotein (LDL) blood concentrations.
Change History Complete list of historical versions of study NCT01968954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in 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 Apolipoprotein B (ApoB) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in 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 12 in Participants With Primary Hyperlipidemia [ Time Frame: Baseline, Week 12 ]
    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.
  • Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia [ Time Frame: Baseline, Week 12 ]
    Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.
  • 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 Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off [ Time Frame: Baseline, Week 24, 52 ]
    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.
  • Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Percent Change From Baseline in 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-C (LDL-C) at Week 12 by Trigylceride Cut-Off [ Time Frame: Baseline, Week 12 ]
    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.
  • Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in 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 Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) 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 (2.59 Millimoles Per Litre) at Week 12, 24 and 52 [ Time Frame: Week 12, 24 and 52 ]
  • 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 [ Time Frame: Week 12, 24 and 52 ]
  • Plasma PF-04950615 Concentrations at Week 12, 24 and 52 [ Time Frame: Week 12, 24, 52 ]
  • Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline up to the end of study (up to 58 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 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.
  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [ Time Frame: Baseline up to the end of study (up to 58 weeks) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Change from Baseline in Lipid Parameters at Week 12 [ Time Frame: 12 weeks ]
    Mean Total Cholesterol (TC), Apolipoprotein B, non-HDL-C, Low Density Lipoprotein (LDL) by TG level, High Density Lipoprotein (HDL), Triglycerides (TG), ApoA-I, ApoA-II blood concentrations.
  • Change from Baseline in Lipid Parameters at Week 24 [ Time Frame: 24 weeks ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and LDL by TG, lipoprotein (a), and High Density Lipoprotein (HDL), TG, ApoA-I, ApoA-II, blood concentrations.
  • Change from Baseline in Lipid Parameters at Week 52 [ Time Frame: 52 weeks ]
    Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL) and LDL by TG, lipoprotein (a), and High Density Lipoprotein (HDL), TG, ApoA-I, 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
Current Other Pre-specified Outcome Measures
 (submitted: April 6, 2017)
  • Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  • Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Drug: Bococizumab (PF-04950615;RN316)
    150 mg every 2 weeks, subcutaneous injection, 12 months
    Other Name: RN316
  • Other: Placebo
    subcutaneous injection, every 2 weeks for 12 months
Study Arms  ICMJE
  • Experimental: 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: February 16, 2017)
711
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
600
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Australia,   Canada,   Czech Republic,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Poland,   United States
Removed Location Countries China
 
Administrative Information
NCT Number  ICMJE NCT01968954
Other Study ID Numbers  ICMJE B1481019
2013-002642-37 ( EudraCT Number )
SPIRE-HR ( Other Identifier: Alias Study 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 March 2017

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