At each site patients were randomized in a 1:1 ratio. Allocation to nicardipine or labetalol was balanced in blocks of four for each of the 13 sites. Sealed envelopes were created by C5 (the coordinating research organization), and provided to the sites. Each had a label indicating selleckchem Olaparib the protocol name, site number, and patient study ID number. Randomization slips in the envelope contained the same information as the labels, as well as the randomized treatment. Sequence was concealed until interventions were assigned. Patients were enrolled by each site’s research coordinator who was blinded to the randomization process.Demographic tables include all randomized patients. Primary efficacy (all randomized patients) and safety (all patients receiving at least one dose of study medication) endpoints include only patients who completed the first 30 minutes of the study.

For outcomes, dichotomous variables were compared by Chi-square or Fisher’s Exact test where appropriate, and continuous variables by Student’s T-test or appropriate nonparametric test. Missing values were not imputed and only observed values were used for analyses. A multivariable logistic model to assess the factors for “met target SBP within 30 minutes”, after controlling for site differences, was developed (Table (Table1).1). All baseline variables with no more than 10% missing data points were considered for inclusion into an adjusted model. A stepwise elimination procedure was used to determine the final model. A P value less than 0.05 was considered as a significant risk factor and included in the final model.

All statistical analyses were performed using SAS version 9.1 (SAS Institute, Cary, NC, USA).Table 1Final multivariable logistic regression model? for “met target systolic blood pressure within first 30 minutes”.ResultsWe enrolled 226 patients from 13 centers, from 16 December, 2008 until 19 January, 2010. Overall, 53% were female, and 76% were black, with a mean age of 52.6 �� 14.6 years. Randomization resulted in 110 patients receiving nicardipine and 116 labetalol, with enrollment as per Figure Figure1.1. Time from ED admission until study drug administration was similar for the nicardipine (median 2.0, interquartile range (IQR) 1.5, 2.8) and labetalol groups (median 1.9, IQR 1.3, 2.7 hours; P = 0.338).Figure 1Patient entry into CLUE trial.

Demographic, historical clinical, and laboratory parameters are presented in Table Table2.2. Of these the nicardipine cohort was more likely to be diabetic (P Brefeldin_A = 0.03) or have hyperlipidemia (P = 0.02), and the labetalol cohort was more likely to have a social history of past and/or current smoking (P = 0.02; Table Table22).Table 2Comparison of the characteristics of patients receiving either nicardipine or labetalolThere were no significant differences between the nicardipine and labetalol populations in regards to past medical history.