This multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality in patients with stable coronary heart disease (CHD), with CHD risk equivalents or at elevated risk for cardiovascular disease. Eligible patients will be randomized to receive either dalcetrapib 600 mg orally daily or placebo orally daily, on a background of contemporary, guidelines-based medical care. Anticipated time on study treatment is 4 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,220
Guidelines-based medical care
Matching dalcetrapib placebo orally daily
600 mg orally daily
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Anaheim, California, United States
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Fullerton, California, United States
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San Diego, California, United States
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Time to first occurrence of any component of the composite cardiovascular event (cardiovascular mortality and morbidity)
Time frame: approximately 4 years
All cause mortality
Time frame: approximately 4 years
Safety: Incidence of adverse events
Time frame: approximately 4 years
Change in blood lipid and lipoprotein levels
Time frame: from baseline to 12 months
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Santa Ana, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Torrance, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
...and 231 more locations