The schematic of both studies is depicted in figure 1. All participating sites had IRB approval and each subject signed an informed consent PRT062607 manufacturer form before participating in the study. Fig. 1 Schematic designs of (a) study H2303 and (b) study H2304. In study H2303, after a 2-week drug washout period, all patients with a mean sitting diastolic BP (MSDBP) of ≥95 mmHg and <110 mmHg entered a single-blind period of treatment with benazepril 40 mg/day for 4 weeks. At the end of this period, those patients whose MSDBP was ≥95 mmHg and <110 mmHg were equally randomized to combination therapy with benazepril 40 mg plus amlodipine 5 mg [amlodipine/benazepril 5/40 mg] per day for 4 weeks and then
were force-titrated to amlodipine/benazepril 10/40 mg/day for an additional 4 weeks. The other patients continued on benazepril 40 mg/day for 8 weeks. In study H2304, the same study design was followed as in H2303, with the exception that the single-blind monotherapy period for 4 weeks consisted of amlodipine 10 mg/day. At the end of 4 weeks, those patients whose MSDBP was ≥95 mmHg and <110 mmHg were equally randomized into three groups. Group 1 was randomized to amlodipine/benazepril 10/20 mg/day for 2 weeks and then force-titrated to amlodipine/benazepril 10/40 mg/day for an additional 6 weeks. Group 2 was randomized to amlodipine/benazepril 10/20 mg/day for 8 weeks, and group 3 continued on amlodipine 10 mg/day
for 8 weeks. Patients with severe hypertension (MSDBP ≥115 mmHg and mean seated systolic blood pressure Avapritinib mouse Sorafenib clinical trial [MSSBP] ≥180 mmHg) were excluded from participation in the studies. Also, females with childbearing potential
were required to practice an effective method of contraception in order to participate in the studies and, in addition, patients with serious medical conditions were excluded from participation. The sitting BP was measured at approximately 24 ± 2 hours after the previous dose of study medication in the office with a mercury sphygmomanometer after 5 minutes of sitting, in the same arm and by the same person, approximately 80% of the time. Three BP readings 2 minutes apart were taken, and the values were averaged. The safety of the drugs was assessed by close monitoring of all clinical and metabolic side effects. Statistical Analysis Because of the find more similarities of patients receiving amlodipine/benazepril 10/40 mg/day, the data from these patients in both studies were pooled to increase the sample size. The baseline demographics at the end of the baseline monotherapies are listed in table I. This table lists the baseline data by treatment group for both Black and White patients. The efficacy and safety of treatment regimens was performed by intent-to-treat (ITT) analysis. In this analysis, all patients who took at least one dose of randomized study medication and had a baseline and at least one post-randomization efficacy measurement were included.