Methods |
4‐ to 5‐week single‐blind placebo run‐in; inclusion criteria= mean sitting DBP 95‐110 mm Hg at consecutive visits (third and fourth weeks, or fourth and fifth weeks) during run‐in; 8‐week double‐blind treatment |
Participants |
All patients: n=548(335 males,213 females); mean age=51.5(11.0) years; baseline sitting SBP=149.5(15.7) mm Hg, DBP=100.1(4.0) mm Hg;
Fosinopril 2.5 mg: n=33 randomized; BP data reported for n=29; baseline sitting SBP=153.0 mm Hg, DBP=100.4 mm Hg;
Fosinopril 10 mg: n=30 randomized; BP data reported for n=29; baseline sitting SBP=147.4 mm Hg, DBP=99.6 mm Hg;
Fosinopril 40 mg: n=32 randomized; BP data reported for n=28; baseline sitting SBP=147.2 mm Hg, DBP=98.6 mm Hg;
Placebo: n=32 randomized; BP data reported for n=29; baseline sitting SBP=150.4 mm Hg, DBP=99.8 mm Hg |
Interventions |
Fosinopril 2.5 mg once daily;
Fosinopril 10 mg once daily;
Fosinopril 40 mg once daily;
Placebo |
Outcomes |
Adjusted mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer;
Trough sitting SBP/DBP using mercury sphygmomanometer;
WDAE |
Notes |
Adjusted BP change reported, SD of change not reported, endpoint BP reported; endpoint SD not reported; baseline SD not reported; imputed overall trial mean SD of change for SBP and DBP; used endpoint BP data to calculated change in BP instead of entering adjusted BP change data; BP data from Tables 3 and 4, p. 120; Jadad score=3; funding source= Bristol‐Myers Squibb |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |