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. 2017 Mar 6;2017(3):CD009868. doi: 10.1002/14651858.CD009868.pub3

NCT01362218.

Methods Randomised open‐label, parallel assignment
Participants Male or female participants aged ≥ 18 and < 75 years
Previously untreated or not treated with fibrates during the last 6 weeks or with any other lipid‐lowering drug for the last 4 weeks
LDL‐cholesterol ≥ 130 and ≤ 220 mg/dL
Systolic blood pressure ≥ 120 and < 160 mmHg and diastolic blood pressure ≥ 70 and < 100 mmHg
Interventions Drug: cardiovascular fixed‐dose combination pill (acetylsalicylic acid, simvastatin and ramipril)
Comparator: simvastatin given together with the reference drugs ramipril and acetylsalicylic acid
Outcomes Primary outcomes
  • Difference in LDL‐cholesterol levels between the basal and the final visit of treatment period


Secondary outcomes
  • Difference in VLDL‐cholesterol levels between the basal and the final visit of treatment period

  • Difference in HDL‐cholesterol levels between the basal and the final visit of treatment period

  • Difference in total cholesterol levels between the basal and the final visit of treatment period

  • Difference in triglyceride levels between the basal and the final visit of treatment period

Notes