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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Biological: Bococizumab 75mg placebo; Biological: Bococizumab 150mg placebo; Biological: Bococizumab 150mg; Biological: Bococizumab 75mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02458287

B1481046

SPIRE-AI (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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299 participants in 4 patient groups, including a placebo group

Bococizumab 150mg

Experimental group

Description:

Bococizumab 150mg autoinjector (pre-filled pen)

Treatment:

Biological: Bococizumab 150mg

Bococizumab 75mg

Experimental group

Description:

Bococizumab 75mg autoinjector (pre-filled pen)

Treatment:

Biological: Bococizumab 75mg

Bococizumab 150mg placebo

Placebo Comparator group

Description:

Bococizumab 150mg placebo autoinjector (pre-filled pen)

Treatment:

Biological: Bococizumab 150mg placebo

Bococizumab 75mg placebo

Placebo Comparator group

Description:

Bococizumab 75mg autoinjector (pre-filled pen)

Treatment:

Biological: Bococizumab 75mg placebo