| Methods |
3‐ to 4‐week single‐blind placebo run‐in; inclusion criteria= sitting DBP 100‐119 mm Hg; 6‐week double‐blind treatment |
| Participants |
Spirapril 6 mg: n=66(32 males,34 females); mean age=58(11) years; baseline sitting SBP=171(12) mm Hg, DBP=106(4) mm Hg, HR=76(10) bpm;
Spirapril 12 mg: n=64(23 males,41 females); mean age=58(9) years; baseline sitting SBP=168(14) mm Hg, DBP=105(4) mm Hg, HR=73(9) bpm;
Spirapril 24 mg: n=66(35 males,31 females); mean age=58(11) years; baseline sitting SBP=170(12) mm Hg, DBP=106(4) mm Hg, HR=74(9) bpm;
Placebo: n=64(24 males, 40 females); mean age=57(11) years; baseline sitting SBP=167(11) mm Hg, DBP=105(3) mm Hg, HR=73(9) bpm |
| Interventions |
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 reported but values are too low, endpoint SBP not reported, endpoint DBP reported, endpoint SD not reported; change in trough BP data from Table II, p. 83; SD of change data from Figure 2, p. 85; change in peak DBP data in subgroup of patients (from one study center) in Figure 3, p. 85; Table II provides data for both efficacy and intention‐to‐treat (ITT) analysis, ITT analysis BP data used instead of efficacy analysis BP data; imputed baseline SBP SD for SBP SD of change; imputed overall trial mean DBP SD of change; Jadad score=3; funding source= Sandoz Pharma |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
