24-HOUR ANTIHYPERTENSIVE EFFECT OF ORAL CILAZAPRIL - A PLACEBO-CONTROLLED STUDY EVALUATING 1,2.5 AND 5MG ONCE-DAILY

The 24-hour effect of cilazapril monotherapy on blood pressure was eva luated in a controlled, double-blind, randomised, dose-response trial carried out in 6 Scandinavian centres. After 4 weeks of single-blind p lacebo administration, male and female outpatients aged between 18 and 65 years with recently or previously diagnosed mild to moderate hyper tension were considered for entry. To be included, the following blood pressure criteria had to be fulfilled: a mean predose sitting diastol ic blood pressure between 100 and 115mm Hg at outpatient visits after 3 and 4 weeks of placebo. Furthermore, a mean baseline diastolic blood pressure greater than or equal to 100mm Hg at hourly measurements 21 to 24 hours postplacebo and also during the wholeblood pressure profil e, i.e. hourly measurements-1 to 8 hours and 21 to 24 hours postdose. Patients were randomly allocated to treatment with cilazapril 1, 2.5 o r 5mg once daily or continued with placebo. Patients were seen in the outpatient clinic 2, 4, 6 and 8 weeks after starting double-blind stud y medication and new blood pressure profile measurements were performe d after 4 and 8 weeks. A total of 169 patients were included in the do uble-blind treatment phase of the study. There were no differences in demographics between the groups. There was no difference in blood pres sure meaurements between the treatment groups in the period 21 to 24 h ours postdose, which was the primary end-point of the study. Furthermo re, no differences were detected in blood pressure measured during out patient visits 24 hours after drug administration. In conclusion, in t he present study none of the doses of cilazapril 1, 2.5 or 5mg once da ily lowered blood pressure for 24 hours.