A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:8/3/2016
Start Date:July 2005
End Date:May 2006

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered
with pravastatin in patients with low or relatively low HDL-C levels. Patients will be
randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or
placebo po daily, for 12 weeks.All patients will also receive pravastatin 40mg po daily for
12 weeks.The anticipated time on study treatment is 3 months and the target sample size is
100-500 individuals.


Inclusion Criteria:

- adult patients 18-75 years of age;

- dyslipidemic patients with low or relatively low HDL-C levels during treatment with
pravastatin.

Exclusion Criteria:

- women who are pregnant, breastfeeding, or of child-bearing potential;

- morbid obesity;

- uncontrolled hypertension;

- poorly controlled or insulin-treated diabetes;

- high creatinine levels or history of statin-associated myopathy.
We found this trial at
33
sites
Clinical Trial Facility in Newark Delaware
Newark, Delaware
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Newark, DE
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Clinical Trial Facility in Auburn Maine
Auburn, Maine 04210
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Auburn, ME
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, MD
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Clinical Trial Facility in Bethesda Maryland
Bethesda, Maryland
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Bethesda, MD
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Clinical Trial Facility in Chalmette Louisiana
Chalmette, Louisiana 70043
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Chalmette, LA
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Clinical Trial Facility in Charlotte North Carolina
Charlotte, North Carolina 28207
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Charlotte, NC
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Chicago, IL
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Concord New Hampshire
Concord, New Hampshire
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Concord, NH
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Clinical Trial Facility in Evansville Indiana
Evansville, Indiana 47713
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Evansville, IN
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Fort Worth, TX
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Houston, TX
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Iowa City Iowa
Iowa City, Iowa 52242
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Iowa City, IA
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Clinical Trial Facility in Louisville Kentucky
Louisville, Kentucky 40202
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Louisville, KY
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Clinical Trial Facility in Madison Wisconsin
Madison, Wisconsin 53792
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Madison, WI
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in Mobile Alabama
Mobile, Alabama
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Mobile, AL
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Clinical Trial Facility in Oklahoma City Oklahoma
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Clinical Trial Facility in Overland Park Kansas
Overland Park, Kansas
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Overland Park, KS
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Clinical Trial Facility in Philidelphia Pennsylvania
415 Curie Boulevard
Philidelphia, Pennsylvania 19104
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Philidelphia, PA
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Clinical Trial Facility in Richmond Virginia
Richmond, Virginia 23227
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Richmond, VA
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Clinical Trial Facility in Scarborough Maine
Scarborough, Maine 04074
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Scarborough, ME
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Clinical Trial Facility in Scottsdale Arizona
Scottsdale, Arizona
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Scottsdale, AZ
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Clinical Trial Facility in Seattle Washington
Seattle, Washington 98105
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Seattle, WA
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Clinical Trial Facility in Slidell Louisiana
Slidell, Louisiana 70458
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Slidell, LA
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Clinical Trial Facility in Springdale Ohio
Springdale, Ohio 45246
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Springdale, OH
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Clinical Trial Facility in St Louis Missouri
St Louis, Missouri
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St Louis, MO
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Clinical Trial Facility in Statesville North Carolina
Statesville, North Carolina 28677
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Statesville, NC
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Clinical Trial Facility in Townson Maryland
Townson, Maryland 21204
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Townson, MD
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Clinical Trial Facility in Warminster Pennsylvania
Warminster, Pennsylvania
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Warminster, PA
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Clinical Trial Facility in Wichita Kansas
Wichita, Kansas 67214
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Wichita, KS
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Clinical Trial Facility in Winston-Salem North Carolina
Winston-Salem, North Carolina
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Winston-Salem, NC
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