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Completed

NCT Number: NCT01968967

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With 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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Discovery Clinical Services Ltd., Victoria, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bococizumab (PF-04950615; RN316)

Drug

150 mg every 2 weeks, subcutaneous injection, 12 months

Placebo

Other

subcutaneous injection every 2 weeks for 12 months

Primary outcomes

  1. Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Time frame: Baseline, Week 12

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Acronym: SPIRE-LDL

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Oct 24, 2013
Registry last updated
Jul 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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