Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins (SPIRE-SI)

November 17, 2017 updated by: Pfizer

A Phase 3, Double-blind, Double-dummy, Randomized, Placebo And Active Controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Dyslipidemia Who Are Intolerant To Statins

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4W2
        • Clinique des maladies lipidiques de Quebec
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • The Medical Arts Health Research Group
    • Ontario
      • Corunna, Ontario, Canada, N0N 1G0
        • Corunna Medical Research Centre
      • Oshawa, Ontario, Canada, L1J 2K1
        • The Office of Dr. James Cha
      • Peterborough, Ontario, Canada, K9J 0B2
        • Kawartha Cardiology Clinical Trials
      • Woodstock, Ontario, Canada, N4S 5P5
        • Devonshire Clinical Research Inc.
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Mirabel, Quebec, Canada, J7J 2K8
        • Omnispec clinical research inc.
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • Diex Research Sherbrooke Inc.
  • United States
    • Colorado
      • Denver, Colorado, United States, 80209
        • Creekside Endocrine Associates, PC
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
    • Florida
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center for Research, Inc. (for Drug Shipment only)
      • Miami, Florida, United States, 33173
        • Cardiovascular Research Center of South Florida
      • Ponte Vedra, Florida, United States, 32081
        • St. Johns Center for Clinical Research
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem - Evanston Hospital
      • Mokena, Illinois, United States, 60448
        • Health Care Centers of Illinois Mokena Medical Commons
      • Normal, Illinois, United States, 61761
        • Advocate Medical Group Cardiology
      • Park Ridge, Illinois, United States, 60068
        • Advocate Medical Group Midwest Heart Specialists
      • Springfield, Illinois, United States, 62769
        • St. John's Hospital
      • Springfield, Illinois, United States, 62701
        • Prairie Heart Institute
      • Springfield, Illinois, United States, 62701
        • Prairie Education & Research Cooperative (Administrative)
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa - College of Public Health - Preventive Intervention Center
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic, PC
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health System, dba Abbott Northwestern Hospital
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Dayton, Ohio, United States, 45414
        • Dayton Heart Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
      • Philadelphia, Pennsylvania, United States, 19104
        • Clinical and Translational Research Center, Hospital of the University of Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Berks Cardiologists, Ltd.
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Pmg Research of Bristol
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville, LLC
    • Texas
      • Fort Sam Houston, Texas, United States, 78234-6200
        • San Antonio Military Medical Center
      • Houston, Texas, United States, 77090
        • Office of Michelle Zaniewski MD., PA.
    • Utah
      • Layton, Utah, United States, 84041
        • Utah Cardiology, P.C.
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hyperlipidemia
  • Statin Intolerant
  • Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Cardiovascular or cerebrovascular event or procedure within 90 days
  • Severe or life-threatening adverse events with past use of statins
  • Poorly controlled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo for Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks
Other: Placebo for atorvastatin
PO QD
Active Comparator: Atorvastatin
Drug: Atorvastatin
Atorvastatin PO QD
Experimental: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg every 2 weeks by subcutaneous injection for 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24
Time Frame: Baseline, Week 12, 24
Baseline, Week 12, 24
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24
Time Frame: Week 12, 24
Week 12, 24
Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24
Time Frame: Week 12, 24
Week 12, 24
Plasma PF-04950615 Concentrations at Weeks 12 and 24
Time Frame: Week 12 and 24
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.
Week 12 and 24
Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations
Time Frame: Baseline (Day 1) up to Week 30
Baseline (Day 1) up to Week 30
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Time Frame: Baseline up to Week 30
Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Baseline up to Week 30
Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively
Time Frame: Week 4, 12, 24 and 30 (Follow-up)
Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.
Week 4, 12, 24 and 30 (Follow-up)
Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations
Time Frame: Baseline (Day 1) up to Week 30
Baseline (Day 1) up to Week 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1481030
  • STATIN INTOLERANT
  • SPIRE-SI (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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