This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order about 52 subjects to finish the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
36
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks.
A once daily oral dose of simvastatin for 12 weeks.
Mount Sinai Medical Center
New York, New York, United States
The Difference in LDL Cholesterol Levels Between the Basal and the Final Visit of Each Treatment Period.
Change from baseline in LDL cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
Time frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
The Difference in Mean Total Cholesterol Between the Basal and the Final Visit of Each Treatment Period.
Change from baseline in mean total cholesterol level following each Treatment Period was defined as the difference between the measurements from the baseline visit (Visit 4, Day 1) and Visit 9 (Day 84) for Treatment Period 1, and between the Visit 11 (Day 126) and Visit 16 (Day 210) for Treatment Period 2.
Time frame: Day 1 and Day 84 of the Period 1 and Day 126 and Day 210 of Period 2
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