Skip to main content
OpenTrials
Completed

NCT Number: NCT01968954

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.

Completed

Looking for future studies?

Notify Me

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

Australian Clinical Research Network, Maroubra, New South Wales, Australia

Loading trial locations.

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

Other names: RN316

Placebo

Other

subcutaneous injection, every 2 weeks for 12 months

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  2. 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

  3. Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  4. Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  5. Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  6. 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.

  7. 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.

  8. Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52

    Time frame: Baseline, Week 24, 52

  9. 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.

  10. Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  11. Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  12. Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  13. 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

  14. 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.

  15. 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

  16. Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  17. 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

  18. Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  19. Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  20. Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  21. 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

  22. 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

  23. 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

  24. 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

  25. Plasma PF-04950615 Concentrations at Week 12, 24 and 52

    Time frame: Week 12, 24, 52

  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 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.

  27. 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.

Other outcomes

  1. Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  2. Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

  3. Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52

    Time frame: Baseline, Week 12, 24, 52

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, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Acronym: SPIRE-HR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2013
Registry last updated
May 17, 2017

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.