Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

NCT02100514

Last updated date

March 13, 2019

ABOUT THIS STUDY

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.

Study Location

Advanced Cardiovascular, LLC Research

Alexander City, Alabama, 35010, United States

See other locations

Contact

1-800-718-1021

[email protected]

Eligibility Criteria

condition

Hyperlipidemia

Sex

Females and Males

Age

18 + years

Inclusion Criteria

Show details

- 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

Show details

- Pregnant or breastfeeding females

- Cardiovascular or cerebrovascular event or procedure within 90 days

- Congestive heart failure NYHA class IV

- Poorly controlled hypertension

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information

Descriptive Information

Brief Title ^ICMJE

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Official Title ^ICMJE

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

Brief Summary

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection for 52 weeks.
Other: Placebo
Subcutaneous injection every 2 weeks for 52 weeks.

Study Arms ^ICMJE

Experimental: Bococizumab (PF-04950615; RN316)
Bococizumab (PF-04950615; RN316)
Intervention: Drug: Bococizumab (PF-04950615; RN316)
Placebo Comparator: placebo
Intervention: Other: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

746

Original Estimated Enrollment ^ICMJE

939

Actual Study Completion Date ^ICMJE

July 10, 2017

Actual Primary Completion Date

July 15, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, Czechia, Finland, Korea, Republic of, Netherlands, Norway, Poland, Puerto Rico, Singapore, Sweden, United Kingdom, United States

Removed Location Countries

Czech Republic

Administrative Information

NCT Number ^ICMJE

NCT02100514

Other Study ID Numbers ^ICMJE

B1481045
SPIRE-LL ( Other Identifier: Alias Study Number )
2014-000478-20 ( EudraCT Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

July 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events

NCT02100514

ABOUT THIS STUDY

FOR MORE INFORMATION

NEED INFO?

TRY A NEW SEARCH

Based on your search, you may also be interested in