Effects of nilvadipine and amlodipine in patients with mild to moderate essential hypertension: a double blind, prospective, randomised clinical trial

ABSTRACTObjective: This double blind, prospective, randomised, parallel group clinical trial was aimed at investigating the effects of nilvadipine or amlodipine in mild to moderate hypertensive patients over a 3-month treatment period.Research design and methods: Eligible outpatients (supine DBP ≥ 90 mmHg and ≤ 110 mmHg and supine SBP ≤ 180 mmHg) entered a maximum 15-day placebo run-in period and were randomised to receive once daily nilvadipine 8 mg or amlodipine 5 mg (to be doubled in the case of lack of response at day 30). Follow-up visits with measurement of supine and orthostatic blood pressure and heart rate were performed after 15, 30, 60 and 90 days of treatment. Standard laboratory tests and 12-lead ECG were performed at study entry and at the end of treatment; adverse events were collected at any time.Results: A total number of 168 patients, 83 in the nilvadipine and 85 in the amlodipine group, took part in the study: 15 and 14 in the two groups, respectively, were prematurely withdrawn. Supine...