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

Summary

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

Conditions

• Hypercholesterolemia
• Dyslipidemia

Interventions

BIOLOGICAL

Placebo

Intravenous placebo monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Satin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

BIOLOGICAL

PF-04950615 (RN316)

Intravenous 10mg/mL based on weight monthly during treatment phase.

DRUG

Statin

Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2012-02-29

Completion

2012-06-30

Countries

• United States
• Canada

Study Locations