A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 70
Updated:12/6/2018
Start Date:July 2012
End Date:October 2013

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A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort

This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or
multiple fixed subcutaneous and intravenous administrations of PF 05335810 to
hypercholesterolemic subjects when added on to a daily statin dose.


Inclusion Criteria:

- On stable daily doses of a statin for 45 days prior to receiving study treatment.

- Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1
week prior to randomization.

Exclusion Criteria:

- History of a cardiovascular or cerebrovascular event or procedure within one year of
randomization.

- Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
We found this trial at
7
sites
Cincinnati, Ohio 45242
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Cincinnati, OH
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Kalamazoo, Michigan 49048
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Kalamazoo, MI
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Miami, Florida 33155
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Miami, FL
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New Haven, Connecticut 06504
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New Haven, CT
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Overland Park, Kansas 66215
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Overland Park, KS
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San Antonio, Texas 78258
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San Antonio, TX
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South Miami, Florida 33143
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South Miami, FL
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