A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Dyslipidemia

Treatments: Drug: Statin; Drug: Satin; Biological: PF-04950615 (RN316); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342211

B1481005

Details and patient eligibility

About

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
• Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL

Exclusion criteria

• History of a cardiovascular or cerebrovascular event or procedure during the past year.
• Poorly controlled type 1 or type 2 diabetes mellitus.
• Poorly controlled hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 5 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Treatment:

Biological: Placebo

Drug: Statin

Drug: Statin

Drug: Statin

Drug: Statin

Treatment B

Experimental group

Treatment:

Drug: Statin

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin

Treatment C

Experimental group

Treatment:

Drug: Statin

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin

Treatment D

Experimental group

Treatment:

Drug: Satin

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Treatment E

Experimental group

Treatment:

Drug: Statin

Biological: PF-04950615 (RN316)

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin

Biological: PF-04950615 (RN316)

Drug: Statin