Appeal No. 1997-1842
Application 08/068,878
placebo, and 2, 5 and 10mg terazosin. The dose response data in that study indicated
that the clinical response to terazosin may not reach a plateau even at 10 mg.
Page 1556, column 2, lines 25-35.
18. Lepor 1992 concluded that their study demonstrated the safety, efficacy and
compliance of terazosin therapy for BPH during a two-year follow-up. Page 1556,
column 2, first full paragraph.
19. Dunzendorfer reported the results of a six-month clinical study of the use of
terazosin for the treatment of symptomatic BPH. Fifteen patients with diagnosed BPH
participated in the study. The study was divided into two parts: (1) a four-week, single-
blind, placebo lead-in period, and (2) a six-month, single-blind treatment period. At the
first and second lead-in visits, patients were given a placebo. At the final visit of the
placebo lead-in period, each patient received an initial daily dose of 1 mg terazosin for
the first two weeks of the treatment period. The daily dosage was increased
sequentially at subsequent two week intervals to 2, 5 and 10 mg until there was a
therapeutic response to treatment at a particular dose or until maximum daily dosage of
10 mg terazosin was reached. Patients were then maintained at that dose for the
remainder of the study. Page 1290, column 1, section 2.3.
20. Dunzendorfer reported that the obstructive and irritative symptom scores
decreased by 55% and 24%, respectively, after six months of terazosin therapy. The
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