HyperlipidemiaPhase 3SPIRE-AINCT02458287

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

A Phase 3 study testing Bococizumab 150mg and Bococizumab 75mg in people with Hyperlipidemia, run by Pfizer at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyperlipidemia
What is being tested?: Bococizumab 150mg and Bococizumab 75mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 299 participants
Where: 30 sitesUnited States
Study dates: Jun 2015to Feb 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL

Who cannot join

Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

ACRC - Cardiology
Atlantis, Florida, 33462
Radiant Research Incorporated
Chandler, Arizona, 85224
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
Clinical Research of South Florida
Coral Gables, Florida, 33134
Evanston Premier Healthcare Research,LLC
Evanston, Illinois, 60201
Invesclinic, LLC
Fort Lauderdale, Florida, 33308
PharmQuest
Greensboro, North Carolina, 27408
Heart Care Associates, P.C.
Hopewell, Virginia, 23860
Texas Center for Drug Development, Inc.
Houston, Texas, 77081
Midwest Institute For Clinical Research
Indianapolis, Indiana, 46260
Clinical Trial Research
Lincoln, California, 95648
National Research Institute
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
Manassas Clinical Research Center
Manassas, Virginia, 20110
Solaris Clinical Research
Meridian, Idaho, 83646
Omega Clinical Research Center
Metairie, Louisiana, 70006
Clinical Research of Miami, Inc.
Miami, Florida, 33126
Prestige Clinical Research Center, Inc.
Miami, Florida, 33133
PMG Research Of Charleston
Mt. Pleasant, South Carolina, 29464
California Medical Research Associates Inc.
Northridge, California, 91324
A & R Research Group LLC
Pembroke Pines, Florida, 33024
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
National Clinical Research-Richmond, Inc.
Richmond, Virginia, 23294
Northern California Research
Sacramento, California, 95821
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Palmetto Clinical Research
Summerville, South Carolina, 29485
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
North Georgia Clinical Research
Woodstock, Georgia, 30189
North Georgia Internal Medicine
Woodstock, Georgia, 30189

Other trials in United States

About this study

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

Conditions: Hyperlipidemia
Being tested: Bococizumab 150mg, Bococizumab 75mg, Bococizumab 150mg placebo, Bococizumab 75mg placebo
Keywords: mixed dyslipidemia
Medical subject headings: Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bococizumab 150mgBiological
Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab 75mgBiological
Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab 150mg placeboBiological
Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
Bococizumab 75mg placeboBiological
Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.

Study groups in NCT02458287
Study group	Role	What they receive
Bococizumab 150mg	Experimental	Bococizumab 150mg autoinjector (pre-filled pen) Receives: Biological: Bococizumab 150mg
Bococizumab 75mg	Experimental	Bococizumab 75mg autoinjector (pre-filled pen) Receives: Biological: Bococizumab 75mg
Bococizumab 150mg placebo	Placebo comparator	Bococizumab 150mg placebo autoinjector (pre-filled pen) Receives: Biological: Bococizumab 150mg placebo
Bococizumab 75mg placebo	Placebo comparator	Bococizumab 75mg autoinjector (pre-filled pen) Receives: Biological: Bococizumab 75mg placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo
Measured: Baseline, Week 12
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 0 (Day 1)
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 2
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 4
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 6
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 8
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 10

Secondary outcomes (10)

Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Measured: Week 0 (Day 1), 2, 4, 6, 8, 10
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8
As per the OAT, a 'successful' injection was based on observer's response for the question - "Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection.
Measured: Week 0 (Day 1), 4, 8
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo
Measured: Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Measured: Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Measured: Baseline, Week 12
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Measured: Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to 18 weeks
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive.
Measured: Baseline up to 18 weeks
Plasma Concentration of Bococizumab at Week 12
Measured: Week 12
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12
PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Feb 2016

First posted1 Jun 2015 (estimated)
Study startJun 2015
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HyperlipidemiaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02458287
Sponsor's protocol ID: B1481046
Other IDs: SPIRE-AI
Acronym: SPIRE-AI
Status last verified: Nov 2017
First submitted: 2 Apr 2015
Last updated: 19 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
PubMed 28304227

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02458287
Acronym / sponsor ID: SPIRE-AI / B1481046
Conditions: Hyperlipidemia
Keywords: mixed dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2015 (actual)
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 1 Jun 2015 (estimated)
Results: Posted 19 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Bococizumab 150mg	Experimental	Biological: Bococizumab 150mgBococizumab 150mg autoinjector (pre-filled pen)
Bococizumab 75mg	Experimental	Biological: Bococizumab 75mgBococizumab 75mg autoinjector (pre-filled pen)
Bococizumab 150mg placebo	Placebo comparator	Biological: Bococizumab 150mg placeboBococizumab 150mg placebo autoinjector (pre-filled pen)
Bococizumab 75mg placebo	Placebo comparator	Biological: Bococizumab 75mg placeboBococizumab 75mg autoinjector (pre-filled pen)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Treated with a statin - Fasting LDL-C >=70mg/dL and triglycerides <=400mg/dL

Key exclusion criteria (1 listed)

Pregnant or breastfeeding females - Cardiovascular or cerebrovascular event or procedures during the past 90 days - Congestive heart failure NYHA class IV - Poorly controlled hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bococizumab 150mgBococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.	Biological	Bococizumab 150mg
Bococizumab 75mgBococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.	Biological	Bococizumab 75mg
Bococizumab 150mg placeboBococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.	Biological	Bococizumab 150mg placebo
Bococizumab 75mg placeboBococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.	Biological	Bococizumab 75mg placebo

Primary outcome

Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo
Time frame: Baseline, Week 12
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)
Time frame: Week 0 (Day 1)
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2
Time frame: Week 2
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4
Time frame: Week 4
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6
Time frame: Week 6
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8
Time frame: Week 8
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"
Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10
Time frame: Week 10
A successful injection based on PAT was an injection where the participant answered "yes" to all the three questions: "Were you able to inject your medicine?" "Has the blue bar moved across the window?" Was the medicine not flowing after needle withdrawn?"

10 secondary outcomes

Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10
Time frame: Week 0 (Day 1), 2, 4, 6, 8, 10
Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8
Time frame: Week 0 (Day 1), 4, 8
Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo
Time frame: Baseline, Week 12
Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12
Time frame: Baseline, Week 12
Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12
Time frame: Baseline, Week 12
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 18 weeks
Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)
Time frame: Baseline up to 18 weeks
Plasma Concentration of Bococizumab at Week 12
Time frame: Week 12
Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 19 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Matched to Bococizumab 150 mg	50	50
Bococizumab 150 mg	100	96
Placebo Matched to Bococizumab 75 mg	49	46
Bococizumab 75 mg	100	97

Primary outcome: Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Placebo Matched to Bococizumab 150 mg n = 50	Bococizumab 150 mg n = 95
Value	6.2 (3.57)	-57.2 (2.57)

Placebo Matched to Bococizumab 150 mg vs Bococizumab 150 mg: LS Mean Difference: -63.4 (95% CI -72.0 to -54.7), p <0.001, Mixed Models Repeated Measures (MMRM)

Population analysed: Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Primary outcome: Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)

Time frame: Week 0 (Day 1). Number. Unit: percentage of injections

Measure	Bococizumab 150 mg n = 100
Value	98

Population analysed: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

Primary outcome: Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2

Time frame: Week 2. Number. Unit: percentage of injections

Measure	Bococizumab 150 mg n = 100
Value	94.2

Population analysed: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

Primary outcome: Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4

Time frame: Week 4. Number. Unit: percentage of injections

Measure	Bococizumab 150 mg n = 100
Value	93.3

Population analysed: Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 18 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Matched to Bococizumab 150 mg	0 of 50 (0%)	4 of 50 (8%)	Not reported
Bococizumab 150 mg	2 of 100 (2%)	6 of 100 (6%)	Not reported
Placebo Matched to Bococizumab 75 mg	3 of 49 (6.1%)	6 of 49 (12.2%)	Not reported
Bococizumab 75 mg	2 of 100 (2%)	5 of 100 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28304227Ridker PM, Tardif JC, Amarenco P, Duggan W, Glynn RJ, Jukema JW, Kastelein JJP, Kim AM, Koenig W, Nissen S, Revkin J, Rose LM, Santos RD, Schwartz PF, Shear CL, Yunis C; SPIRE Investigators. Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab. N Engl J Med. 2017 Apr 20;376(16):1517-1526. doi: 10.1056/NEJMoa1614062. Epub 2017 Mar 17.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

30 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bococizumab 150mg and Bococizumab 75mg in people with Hyperlipidemia, run by Pfizer at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo (time frame: Baseline, Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02458287, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.