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

NCT00697203

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Dyslipidemia

Interventions: Placebo, Pravastatin, Dalcetrapib, Dalcetrapib, Dalcetrapib

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (33)

Mobile, Alabama, United States
Scottsdale, Arizona, United States
Newark, Delaware, United States
Miami, Florida, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Chalmette, Louisiana, United States
Slidell, Louisiana, United States
Auburn, Maine, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Towson, Maryland, United States
St Louis, Missouri, United States
Concord, New Hampshire, United States
Charlotte, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Springdale, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Warminster, Pennsylvania, United States
Fort Worth, Texas, United States
Houston, Texas, United States
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