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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dyslipidemia

In brief

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.

Key facts

Study ID

NCT00697203

Run by

Hoffmann-La Roche

People needed

292

Starts

2005-07-01

Expected to finish

2006-05-01

Last updated by the study team

2020-01-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients 18-75 years of age;
• dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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