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. 2008 Oct 8;2008(4):CD003822. doi: 10.1002/14651858.CD003822.pub2

Fogari 1997.

Methods 4‐to 5‐week placebo run‐in; inclusion criteria= mean sitting DBP 95‐110 mm Hg on days 22, 29 and, if necessary, day 36 (± 3 days) of run‐in; 8‐week double‐blind treatment
Participants Irbesartan 75 mg once daily: n=55(37 males,18 females); mean age=56.7(10.4) years; baseline sitting SBP=157.0(13.4) mm Hg, DBP=101.4(5.2) mm Hg; 
 Irbesartan 150 mg once daily: n=53(32 males,21 females); mean age=54.6(11.7) years; baseline sitting SBP=158.9(13.8) mm Hg, DBP=101.0(5.1) mm Hg; 
 Irbesartan 75 mg twice daily: n=57(36 males,21 females); mean age=54.1(10.6) years; baseline sitting SBP=156.0(12.8) mm Hg, DBP=106.7(4.5) mm Hg; 
 Placebo: n=50(36 males,14 females); mean age=53.3(11.3) years; baseline sitting SBP=158.3(13.4) mm Hg, DBP=101.5(5.0) mm Hg
Interventions Irbesartan 75 mg once daily; 
 Irbesartan 150 mg once daily; 
 Irbesartan 75 mg twice daily; 
 Placebo; 
 once daily dosing: morning dose taken between 7 AM and 10 AM; 
 twice daily dosing: morning dose taken between 7 AM and 10 AM and evening dose approximately 12 h later
Outcomes Mean change from baseline in trough sitting SBP/DBP using mercury sphygmomanometer; 
 WDAE
Notes BP change and SE of change reported, endpoint BP and SD not reported, baseline SD reported; calculated SD from N and SE; BP data from Table 2, p. 1515; Jadad score=4; funding source= Bristol‐Myers Squibb and Sanofi
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear