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. 2014 Aug 31;2014(8):CD010052. doi: 10.1002/14651858.CD010052.pub2

Zanchetti 1993.

Methods Multicenter study involving 2‐week placebo run‐in period, followed by double‐blind, placebo‐controlled treatment period of 4 weeks. ABPM was performed at the end of the placebo run‐in period and on the last day of treatment for a period of 24‐36 hours. Recordings were considered valid if had at least 1 valid BP measurement per hour and at least 24 hours of continuous BP recordings after removal of outlying values by an automatic procedure
Participants Participants with mild‐to‐moderate essential hypertension defined as a sitting clinic DBP 95‐114 mmHg were randomized (126 participants). 81 had valid ABPM data and were included in the analysis
Interventions Nifedipine GITS 30 mg (25 participants), nifedipine GITS 60 mg (28 participants), or placebo (28 participants), once daily for 4 weeks. Nifedipine 60 mg and placebo were used for this analysis
Outcomes Antihypertensive efficacy
Notes No information about time of dosing provided. Emailed first author with no response. Assumed 8 a.m. dosing; 'hour 0'
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description of the process of randomization
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 High risk Only participants with study defined "valid" BP measurements included in analysis
Selective reporting (reporting bias) Low risk All outcomes in methods were reported
Other bias High risk Bayer SpA, Milan involved in study group

ABPM: ambulatory blood pressure monitoring; DBP: diastolic blood pressure; SBP: systolic blood pressure; SD: standard deviation.