Fagan 1993.
Methods | Single‐blind 14‐day placebo run‐in period followed by 12‐week double‐blind active treatment period conducted at 12 sites. ABPM was performed at the end of the single‐blind period and repeated during the fourth and eighth weeks of active treatment on a subset of participants from 5 centers | |
Participants | Participants, aged 22‐75 years, with supine DBP of 95‐114 mmHg on 2 consecutive visits during the single‐blind period with a difference no greater than 10 mmHg between the 2 values were randomized (230 participants). A subset of participants were included in the ABPM portion of the study (71 participants) | |
Interventions | Nicardipine sustained release (SR) 30 mg (57 participants), 45 mg (55 participants), or 60 mg(60 participants), or placebo (58 participants), twice‐daily dosing at 12‐hour intervals (9 a.m. and 9 p.m.). For the ABPM substudy, 30 mg had18 participants, 45 mg had 19 participants, and 60 mg had 17 participants. Only the 60 mg arm and the placebo arm data were used in this review | |
Outcomes | Safety and efficacy of nicardipine SR | |
Notes | Only the nicardipine SR 60 mg and placebo were analyzed in this review Lead author contact email not found to ask about unclear risks in bias assessment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | No evidence of randomization of ABPM substudy |
Allocation concealment (selection bias) | Unclear risk | No description of the process |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description of the process |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description of the process |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data for randomized participant s |
Selective reporting (reporting bias) | Low risk | All outcomes in methods were reported |
Other bias | Unclear risk | Funding not specified |