Methods |
3‐ to 4‐week single‐blind placebo run‐in; inclusion criteria= sitting DBP 100‐115 mm Hg, as determined by mean of 3 consecutive BP measurements using either mercury or random‐zero sphygmomanometer; 6‐week double‐blind treatment |
Participants |
All patients: n=283(157 males,126 females); mean age=55 years;
Spirapril 3 mg: n=55;
Spirapril 6 mg: n=61;
Spirapril 12 mg: n=58;
Spirapril 24 mg: n=49;
Placebo: n=60 |
Interventions |
Spirapril 3 mg once daily;
Spirapril 6 mg once daily;
Spirapril 12 mg once daily;
Spirapril 24 mg once daily;
Placebo;
administered in the morning before breakfast |
Outcomes |
Mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer;
WDAE |
Notes |
BP change reported, SD of change not reported; endpoint BP and SD of change not reported; imputed overall trial mean SBP/DBP SD of change; BP data from Figure 1, p. 78; baseline BP for all patients is not reported; Jadad score=3; funding source= Sandoz Pharma |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |