Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins (SPIRE-SI)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02135029

STATIN INTOLERANT

SPIRE-SI (Other Identifier)

B1481030

Details and patient eligibility

About

This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are statin intolerant.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hyperlipidemia
• Statin Intolerant
• Fasting LDL-C > = 70 mg/dL Fasting TG < = 400 mg/dL

Exclusion criteria

• Pregnant or breastfeeding females
• Cardiovascular or cerebrovascular event or procedure within 90 days
• Severe or life-threatening adverse events with past use of statins
• Poorly controlled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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184 participants in 3 patient groups, including a placebo group

Bococizumab (PF-04950615;RN316)

Experimental group

Description:

Bococizumab (PF-04950615;RN316)

Treatment:

Drug: Bococizumab (PF-04950615;RN316)

Atorvastatin

Active Comparator group

Treatment:

Drug: Atorvastatin

Placebo

Placebo Comparator group

Treatment:

Other: Placebo for Bococizumab (PF-04950615;RN316)

Other: Placebo for atorvastatin