A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)
NCT ID: NCT00697203
Last Updated: 2020-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2005-07-31
2006-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dalcetrapib 300mg
Pravastatin
40mg po daily for 12 weeks
Dalcetrapib
300mg po daily for 12 weeks
Dalcetrapib 600mg
Pravastatin
40mg po daily for 12 weeks
Dalcetrapib
600mg po daily for 12 weeks
Dalcetrapib 900mg
Pravastatin
40mg po daily for 12 weeks
Dalcetrapib
900mg po daily for 12 weeks
Placebo
Placebo
po daily for 12 weeks
Pravastatin
40mg po daily for 12 weeks
Interventions
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Placebo
po daily for 12 weeks
Pravastatin
40mg po daily for 12 weeks
Dalcetrapib
300mg po daily for 12 weeks
Dalcetrapib
600mg po daily for 12 weeks
Dalcetrapib
900mg po daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* dyslipidemic patients with low or relatively low HDL-C levels during treatment with pravastatin.
Exclusion Criteria
* morbid obesity;
* uncontrolled hypertension;
* poorly controlled or insulin-treated diabetes;
* high creatinine levels or history of statin-associated myopathy.
18 Years
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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NC18589
Identifier Type: -
Identifier Source: org_study_id
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