Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

Completed · Phase 1

Conditions studied: Hypercholesterolemia, Dyslipidemia

In brief

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.

Key facts

Study ID

NCT01243151

Run by

Pfizer

People needed

68

Starts

2011-02-01

Expected to finish

2011-10-01

Last updated by the study team

2019-01-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• LDL-C must be greater or equal to 130 mg/dl
• BMI must be between 18.5 and 40 kg/m2
• Japanese volunteers must have 4 Japanese grand parents born in Japan

You may not qualify if…

• History of cardiovascular or cerebrovascular event during the past year.
• Poorly controlled type 1 or type 2 diabetes mellitus
• Subjects who have taken lipid lowering therapies within the last 3 months of screening.

Where it is running

• California Clinical Trials Medical Group — Culver City, California, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• SeaView Research, Inc. — Miami, Florida, United States
• SeaView Research, Inc. — Miami, Florida, United States
• Covance Clinical Research Unit, Inc. — Honolulu, Hawaii, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Prism Research — Saint Paul, Minnesota, United States
• Healthcare Discoveries, LLC dba ICON Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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