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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Bococizumab (PF-04950615; RN316); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100514

B1481045

SPIRE-LL (Other Identifier)

2014-000478-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 746 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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746 participants in 2 patient groups, including a placebo group

Bococizumab (PF-04950615; RN316)

Experimental group

Description:

Bococizumab (PF-04950615; RN316)

Treatment:

Drug: Bococizumab (PF-04950615; RN316)

placebo

Placebo Comparator group

Treatment:

Other: Placebo