Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/7/2017
Start Date:July 2012
End Date:May 2013

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A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months 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.
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Lewiston, Maine 04240
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
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860 Peachwood Drive
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30 Pointe Circle
Greenville, South Carolina 29615
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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1148 E. Commerce St.
San Antonio, Texas 78205
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5430 Fredericksburg Road
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6141 Sunset Dr # 301
South Miami, Florida 33143
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1805 N. California Street
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209-939-3877
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500 Chase Parkway
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Albuquerque, NM
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811 Juniper St NE
Atlanta, Georgia 30308
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Davie, Florida 33312
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Dinuba, California 93618
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
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