Uroxatral (Page 4 of 6)

14 CLINICAL STUDIES

Three randomized placebo-controlled, double-blind, parallel-arm, 12-week trials were conducted with the 10 mg daily dose of alfuzosin. In these three trials, 1,608 patients [mean age 64.2 years, range 49–92 years; Caucasian (96.1%), Black (1.6%), Asian (1.1%), Other (1.2%)] were randomized and 473 patients received UROXATRAL 10 mg daily. Table 4 provides the results of the three trials that evaluated the 10 mg dose.

There were two primary efficacy variables in these three studies. The International Prostate Symptom Score (IPSS, or AUA Symptom Score) consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible scores ranging from 0 to 35 with higher numerical scores on the IPSS total symptom score representing greater severity of symptoms. The second efficacy variable was peak urinary flow rate. The peak flow rate was measured just prior to the next dose in study 2 and on average at 16 hours post-dosing in trials 1 and 3.

There was a statistically significant reduction from baseline to last assessment (Week 12) in the IPSS total symptom score versus placebo in all three studies, indicating a reduction in symptom severity (Table 5 and Figures 2, 3, and 4).

Table 4 — Mean Change (SD) from Baseline to week 12 in International Prostate Symptom Score in Three Randomized, Controlled, Double Blind Trials
Trial 1Trial 2Trial 3
Symptom ScorePlacebo(n=167)UROXATRAL10 mg(n=170)Placebo(n=152)UROXATRAL10 mg(n=137)Placebo(n=150)UROXATRAL10 mg(n=151)
*
Difference between baseline and week 12.
Total symptom score
Baseline18.2(6.4)18.2 (6.3)17.7(4.1)17.3 (3.5)17.7(5.0)18.0 (5.4)
Change *-1.6(5.8)-3.6 (4.8)-4.9(5.9)-6.9 (4.9)-4.6(5.8)-6.5 (5.2)
p-value0.0010.0020.007
Figure 2
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Figure 2 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 1

Figure 3
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Figure 3 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 2

Figure 4
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Figure 4 — Mean Change from Baseline in IPSS Total Symptom Score: Trial 3

Peak urinary flow rate was increased statistically significantly from baseline to last assessment (Week 12) versus placebo in trials 1 and 2 (Table 5 and Figures 5, 6, and 7).

Table 5 — Mean (SD) Change from Baseline to Week 12 in Peak Urine Flow Rate (mL/sec) in Three Randomized, Controlled, Double-Blind Trials
Trial 1Trial 2Trial 3
Placebo(n=167)UROXATRAL10 mg(n=170)Placebo(n=147)UROXATRAL10 mg(n=136)Placebo(n=150)UROXATRAL10 mg(n=151)
*
Difference between baseline and week 12.
Mean Peak flow rate
Baseline10.2 (4.0)9.9 (3.9)9.2 (2.0)9.4 (1.9)9.3 (2.6)9.5 (3.0)
Change *0.2 (3.5)1.7 (4.2)1.4 (3.2)2.3 (3.6)0.9 (3.0)1.5 (3.3)
p-value0.00040.030.22
Figure 5
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Figure 5 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 1

Figure 6
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Figure 6 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 2

Figure 7
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Figure 7 — Mean Change from Baseline in Peak Urine Flow Rate (mL/s): Trial 3

Mean total IPSS decreased at the first scheduled observation at Day 28 and mean peak flow rate increased starting at the first scheduled observation at Day 14 in trials 2 and 3 and Day 28 in trial 1.

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