A 52 Week Study To Assess The Use Of Bococizumab (PF-04950615; RN316) In Subjects With Heterozygous Familial Hypercholesterolemia (SPIRE-FH)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Heterozygous Familial Hypercholesterolemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968980

B1481021

SPIRE-HF (Other Identifier)

2013-002644-87 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 370 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.
• Heterozygous familial hypercholesterolemia.

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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370 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