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 the reference products (simvastatin, ramipril, acetylsalicylic acid) Approximately 350 subjects will be screened, 266 randomized in order about 238 subjects to finish the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
107
A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
Hospital Clinic
Barcelona, Spain
Difference in LDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in VLDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in HDL-cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in total cholesterol levels between the basal and the final visit of treatment period.
Time frame: Day 56
• Difference in triglyceride levels between the basal and the final visit of treatment period
Time frame: Day 56
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