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

NCT01968967

Last updated date

March 13, 2019

ABOUT THIS STUDY

This study is a multicenter, randomized study in subjects with high cholesterol receiving highly effective statins to assess the efficacy, safety and tolerability of Bococizumab (PF-04950615;RN316) to lower LDL-C.

Study Location

Ernest L. Hendrix, MD, PC

Athens, Alabama, 35611, 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 > 70 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 of procedures during the past 30 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

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[email protected]

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Advanced Information

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Long-term 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hyperlipidemia

Intervention ^ICMJE

Drug: Bococizumab (PF-04950615; RN316)
150 mg every 2 weeks, subcutaneous injection, 12 months
Other: Placebo
subcutaneous injection every 2 weeks for 12 months

Study Arms ^ICMJE

Experimental: 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

2139

Original Estimated Enrollment ^ICMJE

1600

Actual Study Completion Date ^ICMJE

July 10, 2017

Actual Primary Completion Date

July 5, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Treated with a statin.
Fasting LDL-C > 70 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 of procedures during the past 30 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, Colombia, France, Hungary, Lithuania, Mexico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01968967

Other Study ID Numbers ^ICMJE

B1481020
2013-002643-28 ( EudraCT Number )
SPIRE-LDL ( Other Identifier: Alias Study 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 Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events

NCT01968967

ABOUT THIS STUDY

FOR MORE INFORMATION

NEED INFO?

TRY A NEW SEARCH

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