Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: PBO; 200mg PF-04950615 (RN316); 300mg PF-04950615 (RN316); PBO; PF-04950615; PF-04950615; PF-04950615
Intervention description: Placebo Q28d; PF-04950615 200 mg, Q28d; PF-04950615 300 mg, Q28d; Placebo, Q14d; PF-04950615 50mg, Q14d; PF-04950615 100 mg, Q14d; PF-04950615 150mg, Q14d
Intervention MeSH terms: Bococizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PF-04950615; RN316

Summary:

      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.
    

Eligibility criteria:

        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.