Overview

This trial is active, not recruiting.

Condition cardiovascular disease
Treatments bococizumab (pf-04950615), placebo
Phase phase 3
Sponsor Pfizer
Start date October 2013
End date April 2017
Trial size 10653 participants
Trial identifier NCT01975389, 2013-002795-41, B1481038, CV OUTCOMES 2

Summary

This study evaluates the PCSK9 inhibitor, Bococizumab (PF-04950615;RN316), compared to placebo, in reducing the occurrrence of major cardiovascular events, including cardiovascular death, myocardial infarction, stroke, and unstable angina requiring urgent revascularization in high risk subjects who are receiving background lipid lowering therapy and have cholesterol laboratory values of LDL-C >/= 100 mg/dL (2.6 mmol/L) or non-HDL-C >/=130 mg/dL (3.4 mmol/L).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
150 mg, every 2 weeks, subcutaneous.
bococizumab (pf-04950615) RN316
150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
(Placebo Comparator)
Placebo comparator, every 2 weeks, subcutaneous.
placebo
Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.

Primary Outcomes

Measure
The primary endpoint is the time from randomization to the first occurrence of a major cardiovascular (CV) event, a composite endpoint of CV death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization.
time frame: 60 Months

Secondary Outcomes

Measure
Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke.
time frame: 60 Months
Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization.
time frame: 60 Months
Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of a composite endpoint of all-cause death, non-fatal MI, and non-fatal stroke.
time frame: 60 Months
Key secondary endpoint: The time from randomization to the first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization
time frame: 60 Months
Time to first occurrence of a composite endpoint of CV death, non-fatal MI, and non-fatal stroke, and hospitalization for unstable angina; and each component of every composite endpoint, and an endpoint of hospitalization for congestive heart failure.
time frame: 60 months
Changes in levels of circulating biomarkers (lipids and hs-CRP)
time frame: 60 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Must be on background lipid lowering treatment. - Must be at high risk of a CV event. - Must have an LDL C >/=100 mg/dL (2.6 mmol/L) OR non HDL C >/=130 mg/dL (3.4 mmol/L). Exclusion Criteria: - Planned coronary (PCI or CABG) or other arterial revascularization. - New York Heart Association Class IV congestive heart failure or left ventricular ejection fraction < 25% by cardiac imaging. - Chronic renal insufficiency with creatinine clearance of <30 ml/min/1.73m^2 by MDRD formula or with end state renal disease on dialysis. - History of hemorrhagic stroke. - Prior exposure to bococizumab or other investigational PCSK9 inhibitor.

Additional Information

Official title Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.