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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02100514
First received: March 27, 2014
Last updated: January 30, 2017
Last verified: January 2017
  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: 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 LDL-C at week 12. [ Time Frame: Week 12 ]
    Fasting Low Density Lipoprotein Cholesterol (LDL-C)


Secondary Outcome Measures:
  • Change from baseline in fasting Lipid Parameters at Week 12. [ Time Frame: week 12 ]
    Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, ApoA-II and VLDL-C blood concentrations.

  • Change from baseline in fasting Lipid Parameters at Week 24. [ Time Frame: week 24 ]
    Percent change in fasting LDL-C, Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, ApoA-II and VLDL-C blood concentrations.

  • Change from baseline in fasting Lipid Parameters at Week 52. [ Time Frame: week 52 ]
    Percent change in fasting LDL-C, Percent change in fasting Total Cholesterol (TC), Apolipoprotein B (Apo B), non HDL-C, LDL-C by TG level (<or>=200 mg/dL), Lipoprotein (a) (Lp(a), High Density Lipoprotein (HDL), Triglyceride, ApoA-I, ApoA-II and VLDL-C blood concentrations.

  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 12. [ Time Frame: week 12 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 12

  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 24. [ Time Frame: week 24 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 24.

  • Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 52. [ Time Frame: week 52 ]
    Proportion of subjects achieving fasting LDL-C <=100 mg/dL and <=70 mg/dL at week 52

  • Plasma PF-04950615 concentration at week 12. [ Time Frame: week 12 ]
    Plasma PF-04950615 concentration at week 12

  • Plasma PF-04950615 concentration at week 24. [ Time Frame: week 24 ]
    Plasma PF-04950615 concentration at week 24

  • Plasma PF-04950615 concentration at week 52. [ Time Frame: week 52 ]
    Plasma PF-04950615 concentration at week 52


Estimated Enrollment: 690
Study Start Date: October 2014
Study Completion Date: July 2016
Primary Completion Date: July 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

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
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: 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 )
Study First Received: March 27, 2014
Last Updated: January 30, 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
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 28, 2017