Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Hypercholesterolemia

Dyslipidemia

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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.

Key Trial Info

Start Date :

February 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2011

Estimated Enrollment :

68 Patients enrolled

Trial Details

Trial ID

NCT01243151

Start Date

February 1 2011

End Date

October 1 2011

Last Update

January 22 2019

Active Locations (9)

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Page 1 of 3 (9 locations)

1

California Clinical Trials Medical Group

Culver City, California, United States, 90232

2

Glendale Adventist Medical Center

Glendale, California, United States, 91206

3

SeaView Research, Inc.

Miami, Florida, United States, 33126

4

SeaView Research, Inc.

Miami, Florida, United States, 33134