Conditions: Elevated LDL Cholesterol
Keywords: cardiovascular fixed dose combination pill LDL cholesterol
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril) arm 2: Once daily oral dose of Simvastatin 40 mg

Interventions: intervention 1: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), intervention 2: Simvastatin
Intervention descriptions: intervention 1: A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks. intervention 2: A once daily oral dose of simvastatin for 12 weeks.

Protocol document: