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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-LL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02100514
First Posted: April 1, 2014
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This study is a multicenter, double-blind, randomized study to access the efficacy, safety and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia receiving background statin therapy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 52 Week 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

Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 (Non 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 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 (Non 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 ]
  • Absolute 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 Versus Time Summary of PF-04950615 [ Time Frame: Week 12, 24, 52 ]
  • Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions [ Time Frame: Baseline up to 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. 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 Positive Anti-drug Antibodies (ADA) of PF-04950615 [ Time Frame: Baseline up to end of study (up to 58 weeks) ]
    Percentage of participants with at least 1 positive ADA titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive.


Enrollment: 750
Actual Study Start Date: October 28, 2014
Study Completion Date: July 10, 2017
Primary Completion Date: July 15, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bococizumab (PF-04950615; RN316)
Bococizumab (PF-04950615; RN316)
Drug: Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
Placebo Comparator: placebo Other: Placebo
Subcutaneous injection every 2 weeks for 52 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Treated with a statin
  • Fasting LDL-C >=100 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 or procedure within 90 days
  • Congestive heart failure NYHA class IV
  • Poorly controlled hypertension
  Contacts and Locations
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): NCT02100514


  Show 222 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100514     History of Changes
Other Study ID Numbers: B1481045
SPIRE-LL ( Other Identifier: Alias Study Number )
2014-000478-20 ( EudraCT Number )
First Submitted: March 27, 2014
First Posted: April 1, 2014
Results First Submitted: June 23, 2017
Results First Posted: July 21, 2017
Last Update Posted: November 14, 2017
Last Verified: October 2017

Keywords provided by Pfizer:
Primary hyperlipidemia or mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors.

Additional relevant MeSH terms:
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Metabolic Diseases