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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01720537

Run by

Pfizer

People needed

133

Starts

2012-07-01

Expected to finish

2013-10-01

Last updated by the study team

2018-12-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%).

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — South Miami, Florida, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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