A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

Pfizer

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia; Dyslipidemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01350141

B1481012

Details and patient eligibility

About

PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) of 18.5 to 40 kg/m2
• On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
• Lipids meet the following criteria twice during screening period:
• Fasting LDL C = or > 80 mg/dL;
• Fasting TG < 400 mg/dL.

Exclusion criteria

• History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
• Poorly controlled type 1 or type 2 diabetes mellitus.
• Poorly controlled hypertension.
• Fasting triglycerides > 400 mg/dL
• 12 lead ECG demonstrating QTcFF >455 msec at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 3 patient groups, including a placebo group

Treatment A

Placebo Comparator group

Treatment:

Other: Placebo

Treatment B

Experimental group

Treatment:

Drug: PF-04950615 (RN316)

Drug: PF-04950615 (RN316)

Treatment C

Experimental group

Treatment:

Drug: PF-04950615 (RN316)

Drug: PF-04950615 (RN316)