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.
We found this trial at
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1331
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Albuquerque, NM
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2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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497
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Birmingham, AL
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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DeLand, FL
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30 Pointe Circle
Greenville, South Carolina 29615
(864)255-3540
354
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Greenville, SC
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303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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1148 E. Commerce St.
San Antonio, Texas 78205
(210) 340-5646
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5430 Fredericksburg Road
San Antonio, Texas 78229
210-377-2873
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6141 Sunset Dr # 301
South Miami, Florida 33143
(305) 598-3125
Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
997
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South Miami, FL
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1805 N. California Street
Stockton, California 95204
209-939-3877
2044
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Stockton, CA
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
532
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Waterbury, CT
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
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Atlanta, GA
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Atlanta, Georgia
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Auburn, Maine 04210
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Aurora, IL
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Boise, Idaho 83704
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Boynton Beach, Florida 33437
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Chicago, Illinois 60654
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Cincinnati, Ohio 45219
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Cincinnati, OH
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5000 West Oakland Park Boulevard
Davie, Florida 33312
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1300 North Fresno Street
Dinuba, California 93618
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Duncansville, Pennsylvania 16635
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Houston, TX
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Huntsville, Alabama 35801
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1750 Independence Avenue
Kansas City, Missouri 64106
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Manlius, New York 13104
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7451 Mason Montgomery Road
Mason, Ohio 45040
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Metairie, Louisiana 70006
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Mount Pleasant, South Carolina 29464
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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