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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 : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Drug: Bococizumab (PF-04950615; RN316) Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 29, 2013
Actual Primary Completion Date : July 5, 2016
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Bococizumab (PF-04950615; RN316) Drug: Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Placebo Comparator: Placebo Other: Placebo
subcutaneous injection every 2 weeks for 12 months


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]

Secondary Outcome Measures :
  1. Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  2. Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  7. 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 ]
  8. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period [ Time Frame: Baseline, Week 24, 52 ]
  9. Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  10. Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  11. Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52 [ Time Frame: Baseline, Week 12, 24, 52 ]
  12. 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 ]
  13. 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 ]
  14. 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 ]
  15. Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  16. Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12 [ Time Frame: Baseline, Week 12 ]
  17. Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  18. Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12 [ Time Frame: Baseline, Week 12 ]
  19. Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12 [ Time Frame: Baseline, Week 12 ]
  20. Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12 [ Time Frame: Baseline, Week 12 ]
  21. 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 ]
  22. 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 ]
  23. 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 ]
  24. 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 ]
  25. 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.

  26. Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline 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.

  27. 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 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.

  28. Number of Participants Who Changed Concomitant Medication During Extension Period [ Time Frame: Week 58 follow-up visit 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.

  29. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period [ Time Frame: Baseline, Week 58 follow-up visit, 71, 84, 97, 110 ]
  30. Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period [ Time Frame: Week 58 follow-up visit, 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968967


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968967    
Other Study ID Numbers: B1481020
2013-002643-28 ( EudraCT Number )
SPIRE-LDL ( Other Identifier: Alias Study Number )
First Posted: October 24, 2013    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Pfizer:
mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors
Additional relevant MeSH terms:
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Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases
Bococizumab
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents