Methods |
14‐21 day single‐blind placebo run‐in; inclusion criteria= mean sitting DBP 100‐115 mm Hg after run‐in; 8‐week double‐blind treatment |
Participants |
Olmesartan 5 mg once daily: n=45(30 males, 15 females); mean age=56 years; baseline sitting SBP=151 mm Hg, DBP=96 mm Hg;
Olmesartan 20 mg once daily: n=45(31 males, 14 females); mean age=52 years; baseline 24h SBP=149 mm Hg, DBP=96 mm Hg;
Olmesartan 80 mg once daily: n=48(32 males, 16 females); mean age=52 years; baseline 24h SBP=148 mm Hg, DBP=95 mm Hg;
Olmesartan 2.5 mg twice daily: n=50(34 males, 16 females); mean age=53 years; baseline 24h SBP=148 mm Hg, DBP=94 mm Hg;
Olmesartan 10 mg twice daily: n=48(29 males, 19 females); mean age=53 years; baseline 24h SBP=148 mm Hg, DBP=95 mm Hg;
Olmesartan 40 mg twice daily: n=50(34 males, 16 females); mean age=56 years; baseline 24h SBP=151 mm Hg, DBP=95 mm Hg;
Placebo: n=48(29 males, 19 females); mean age=53 years; baseline 24 h SBP=149 mm Hg, DBP=94 mm Hg |
Interventions |
Olmesartan 5 mg once daily;
Olmesartan 20 mg once daily;
Olmesartan 80 mg once daily;
Olmesartan 2.5 mg twice daily;
Olmesartan 10 mg twice daily;
Olmesartan 40 mg twice daily;
Placebo;
once daily dosing: active drug given in the morning and matched placebo for the evening dose;
twice daily dosing: first dose taken with breakfast and second dose approximately 12 h later |
Outcomes |
Mean change from baseline in trough sitting SBP/DBP;
WDAE |
Notes |
SBP change reported for olmesartan groups, SBP change not reported for placebo group, SBP SD of change not reported for all groups, DBP change reported for all groups, DBP SD of change not reported for all groups, endpoint BP and SD not reported, baseline SD not reported; imputed overall trial mean SBP/DBP SD of change; BP data from Figure 3, p. 327; BP measurement device not reported; Jadad score=3; funding source= Sankyo Pharma |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |