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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01968967
First received: October 21, 2013
Last updated: June 22, 2017
Last verified: June 2017
  Purpose
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 Intervention Phase
Hyperlipidemia Drug: Bococizumab (PF-04950615; RN316) Other: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 (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 (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 ]
  • 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 (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 ]
  • 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 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.

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

  • Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) [ Time Frame: Baseline up to end of study (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 was considered to be ADA positive and nAb titer >=1.58 was considered to be nAb positive.


Enrollment: 1932
Actual Study Start Date: October 29, 2013
Study Completion Date: July 5, 2016
Primary Completion Date: July 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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 > 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968967

  Show 249 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: NCT01968967     History of Changes
Other Study ID Numbers: B1481020
2013-002643-28 ( EudraCT Number )
SPIRE-LDL ( Other Identifier: Alias Study Number )
Study First Received: October 21, 2013
Results First Received: June 22, 2017
Last Updated: June 22, 2017

Keywords provided by Pfizer:
mixed dyslipidemia
high risk of cardiovascular events
multiple cardiovascular disease risk factors

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

ClinicalTrials.gov processed this record on August 18, 2017