Randomized Clinical Trial Of Bococizumab (PF-04950615; RN316) In Subjects With Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events (SPIRE-HR)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968954

SPIRE-HR (Other Identifier)

2013-002642-37 (EudraCT Number)

B1481019

Details and patient eligibility

About

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.

Enrollment: 711 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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711 participants in 2 patient groups, including a placebo group

Bococizumab (PF-04950615;RN316)

Experimental group

Treatment:

Drug: Bococizumab (PF-04950615;RN316)

Placebo

Placebo Comparator group

Treatment:

Other: Placebo