Methods |
2‐week washout; 2‐week single‐blind placebo run‐in; inclusion criteria= mean sitting DBP 100‐114 mm Hg; 6‐week double‐blind treatment phase at fixed dose, patients with inadequate BP response had their doses doubled and were treated for another 6 weeks |
Participants |
Spirapril 3 mg: n= 52(32 males,20 females); mean age=55.8 years; baseline sitting SBP=159.0 mm Hg, DBP=104.6 mm Hg (trough data); baseline sitting SBP=156.7 mm Hg, DBP=103.4 mm Hg (peak data);
Spirapril 6 mg: n= 52(28 males,24 females); mean age=53.6 years; baseline sitting SBP=159.0 mm Hg, DBP=104.8 mm Hg (trough data); baseline sitting SBP=157.6 mm Hg, DBP=102.9 mm Hg (peak data);
Placebo: n= 26(18 males,8 females); mean age=54.2 years; baseline sitting SBP=154.2 mm Hg, DBP=104.1 mm Hg (trough data); baseline sitting SBP=151.6 mm Hg, DBP=102.8 mm Hg (peak data) |
Interventions |
Spirapril 3 mg once daily;
Spirapril 6 mg once daily;
Placebo;
taken in the morning before breakfast |
Outcomes |
Mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer;
Mean change from baseline in peak sitting SBP/DBP using mercury sphygmomanometer;
WDAE |
Notes |
Used week 6 BP data only; BP change and SD of change reported, endpoint BP reported, endpoint SD not reported; change in trough and peak BP data from Table 2A, p. 624; Jadad score=3; funding source= Novartis Pharma |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |