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

NCT01005290.

Methods Randomised open‐label, cross‐over trial
Participants Participants will be ≥ 18 years old. Previously untreated systolic pressure result of ≥ 120 < 160 mmHg and diastolic pressure result of ≥ 80 < 100 mmHg
Interventions A once‐daily oral dose of the cardiovascular fixed‐dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for 1 week followed by a once‐daily oral dose of the cardiovascular fixed‐dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks
Comparator: a once‐daily oral dose of 5 mg ramipril for 1 week followed by a once‐daily oral dose of 10 mg ramipril for 4 weeks
Outcomes Primary outcomes
  • Difference in the adjusted mean 24‐h systolic pressure results (using ABPM (ambulatory blood pressure monitoring)) between the basal and the final visit of each treatment period. (Time frame: days 7 and 36 of period 1 and days 49 and 85 of period 2.) (Designated as safety issue: no)

  • Difference in the adjusted mean 24‐h systolic pressure results using ABPM in the PP population


Secondary outcomes
  • Difference in the adjusted mean 24‐h diastolic pressure results between the basal and the final visit of each treatment period. (Time frame: days 7 and 36 of period 1 and days 49 and 85 of period 2.) (Designated as safety issue: no)

  • Difference in the adjusted mean 24‐h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period

Notes