Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615
 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with
 high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.
Inclusion Criteria:

 -  Subjects should be receiving a stable dose (at least 6 weeks) of any statin and
 continue on same dose of statin for the duration of this trial.

 -  Lipids should meet the following criteria on a background treatment with a statin at 2
 screening visits that occur at screening and at least 7 days prior to randomization on
 Day 1:

 -  Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);

 -  Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).

 -  Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L
 at the initial screening visit, and the value at the second visit within 7 days of
 randomization must be not lower than 20% of this initial value to meet eligibility
 criterion for this trial.

 Exclusion Criteria:

 -  Participation in other studies within 3 months before the current study begins and/or
 during study participation.

 -  Severe acute or chronic medical or psychiatric condition or laboratory abnormality
 that may increase the risk associated with study participation or investigational
 product administration or may interfere with the interpretation of study results and,
 in the judgment of the investigator, would make the subject inappropriate for entry
 into this study.

 -  Pregnant females; breastfeeding females; males and females of childbearing potential
 not using highly effective contraception or not agreeing to continue highly effective
 contraception for at least 63 days after last dose of investigational product.

 -  History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke,
 TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA
 functional classes III or IV.

 -  Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).

 -  Poorly controlled hypertension.