A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

Inclusion Criteria:

• Male or female subjects ≥18 years of age
• Previously untreated LDL cholesterol ≥100 mg/dL and ≤180 mg/dL.
• Provide written informed consent.

Exclusion Criteria:

• Subjects with a medical condition requiring chronic pharmacological treatment
• On direct questioning and physical examination have evidence of any clinically significant chronic disease, including known or suspected human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.
• On direct questioning and physical examination have a medical history or evidence of abuse of drugs.
• Medical history of gastrointestinal bleeding or gastric or duodenal ulcer.
• Systolic pressure ≥140 mmHg or diastolic pressure >89 mmHg requiring hypotensive medication.
• Presence of secondary dyslipidemia.
• Previous use of cholesterol lowering medication.
• Previous coronary artery bypass graft (CABG).
• Previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.
• Presence of severe congestive heart failure (New York Heart Classification [NYHC] III IV).
• Presence of untreated or uncontrolled thyroid disease.
• Past or current medical history of asthma or aspirin induced asthma
• Previous hypersensitivity to ACE inhibitors (eg angioedema or cough).
• Previous hypersensitivity to ARBs.
• History of unstable angina.
• Serum creatinine >2 mg/dL.
• Creatine phosphokinase (CPK) ≥5 x the upper limit of normal (ULN).
• Hemoglobin ≤12 g/dL (120 g/L) for male subjects or ≤10 g/dL (100 g/L) for female subjects.
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 x ULN.
• Total bilirubin ≥1.5 x ULN.
• Serum triglyceride concentration ≥400 mg/dL.
• Subjects not using effective contraception methods (intra uterine device [IUD] and condom or diaphragm with spermicide and condom) during the study and for at least one month thereafter.
• Pregnant, lactating, breastfeeding, or intends to become pregnant during the course of the study (females only). All women must have a negative urine pregnancy test at the Screening Visit, be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) or have a postmenopausal status (no menses) for at least one year.
• Contraindications to or known or suspected hypersensitivity to aspirin, simvastatin or ramipril or their excipients.
• Presence of mental illness limiting the capacity for self-care.
• Presence of major systemic illnesses: renal disease, liver disease, neurological or psychiatric disease.
• Participation, in the 30 days preceding enrolment into the study, in any other clinical study in which investigational or marketed drugs were employed.