Clinical trials with terazosin. General methods.

Terazosin has been studied in a variety of clinical trials conducted in hypertensive patients with supine diastolic blood pressures of 95 mm Hg or greater before treatment. Blood pressure, pulse rate, body weight, clinical laboratory variables, and adverse experience data were evaluated periodically throughout each study. Patients generally were seen at weekly or biweekly intervals. Total daily doses of terazosin ranged from 1 to 40 mg. Terazosin was administered alone and in combination with other antihypertensive agents. Clinical trials consisted of double-blind, controlled studies and long-term, follow-up studies. The controlled clinical trials employed three principal designs: studies in which the dose was titrated according to blood pressure response; studies in which the dose was increased to a fixed level regardless of blood pressure response; and randomized withdrawal studies. Efficacy evaluations were based on mean blood pressure changes from baseline to the final visit and on the distribution of patient responses, which were categorized from excellent to inadequate. Safety evaluations were based principally on comparisons of specific safety parameters before and after the study.