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Efficacy, Safety, Tolerability And Actual Use Study Of Bococizumab And An Autoinjector (Pre-Filled Pen) In Subjects With Hyperlipidemia Or Dyslipidemia (SPIRE-AI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02458287
First received: April 2, 2015
Last updated: March 7, 2017
Last verified: March 2017
  Purpose
This study is a multicenter, randomized study in subjects with high cholesterol receiving statins to assess the efficacy to lower LDL-C, the safety, tolerability and actual use of bococizumab and an autoinjector (pre-filled pen).

Condition Intervention Phase
Hyperlipidemia Biological: Bococizumab 150mg Biological: Bococizumab 75mg Biological: Bococizumab 150mg placebo Biological: Bococizumab 75mg placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A 12 Week, Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel Group Study To Assess The Efficacy, Safety, Tolerability And Actual Use Of Bococizumab And An Autoinjector (Pre-filled Pen) In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage change from baseline in LDL-C 150mg dose [ Time Frame: 12 weeks ]
    Low density lipoprotein (LDL-C) blood concentrations.

  • Delivery system success rate 150mg dose [ Time Frame: 0 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose

  • Delivery system success rate 150mg dose [ Time Frame: 2 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose

  • Delivery system success rate 150mg dose [ Time Frame: 4 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose

  • Delivery system success rate 150mg dose [ Time Frame: 6 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose

  • Delivery system success rate 150mg dose [ Time Frame: 8 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose

  • Delivery system success rate 150mg dose [ Time Frame: 10 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 150mg bococizumab dose


Secondary Outcome Measures:
  • Delivery system success rate 75mg dose [ Time Frame: 0, 2, 4, 6, 8 and 10 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Participant Assessment Tool for the 75mg and combined 150mg and 75mg bococizumab doses

  • Delivery system success rate Observer Assessment Tool [ Time Frame: 0, 4 and 8 weeks ]
    Percentage of subjects whose attempt to operate the system met the definition for successful assessed using the Observer Assessment Tool for the 75mg, 150mg and combined bococizumab doses

  • Percentage change from baseline in LDL-C 75mg dose [ Time Frame: 12 weeks ]
    Low density lipoprotein (LDL-C) blood concentrations

  • Change from baseline in Mean Total Cholesterol (TC) [ Time Frame: 12 weeks ]
    Mean Total Cholesterol (TC) for the bococizumab 150mg and 75mg doses compared to their respective placebos

  • Plasma bococizumab and PCSK9 concentrations [ Time Frame: 12 weeks ]
    Plasma bococizumab and PCK9 concentraions

  • Change from baseline in Apolipoprotein B (ApoB) [ Time Frame: 12 weeks ]
    Apolipoprotein B (ApoB) for the bococizumab 150mg and 75mg doses compared to their respective placebos

  • Change from baseline in non High Density Lipoprotein (HDL-C) [ Time Frame: 12 weeks ]
    Non High Density Lipoprotein (HDL-C) for the bococizumab 150mg and 75mg doses compared to their respective placebos


Enrollment: 299
Study Start Date: June 2015
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bococizumab 150mg
Bococizumab 150mg autoinjector (pre-filled pen)
Biological: Bococizumab 150mg
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
Experimental: Bococizumab 75mg
Bococizumab 75mg autoinjector (pre-filled pen)
Biological: Bococizumab 75mg
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
Placebo Comparator: Bococizumab 150mg placebo
Bococizumab 150mg placebo autoinjector (pre-filled pen)
Biological: Bococizumab 150mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Placebo Comparator: Bococizumab 75mg placebo
Bococizumab 75mg autoinjector (pre-filled pen)
Biological: Bococizumab 75mg placebo
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.

  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 >=70mg/dL and triglycerides <=400mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 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: NCT02458287

  Show 30 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: NCT02458287     History of Changes
Other Study ID Numbers: B1481046
SPIRE-AI ( Other Identifier: Alias Study Number )
Study First Received: April 2, 2015
Last Updated: March 7, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
mixed dyslipidemia

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

ClinicalTrials.gov processed this record on June 22, 2017