Phases Phase 1 28 days Phase 2 6 extension (double blind) Patients on active treatment continued on same treatment Patients on placebo were re-randomised to one of the 4 active treatment groups CS31 was an open label extension of Part 2 of CS29. Patients on 10 µg were re-randomised Measurement of primary endpoint (nocturnal voids) Nocturnal voids were recorded in a diary on 3 consecutive 24 hour periods at baseline and during the first four weeks of the study (Days 8, 15, 22, 28). The pre-specified time point was 28 days. Results Table 4: Results Study CS29; Nocturnal voids Nocturnal Placebo 10 µg 25 µg 50 µg 100 µg voids (n = 156) (n = 155) (n = 152) (n = 148) (n = 146) Baseline 3.3 3.2 3.4 3.4 3.2 (mean) Day 28 (mean) 2.4 2.4 2.4 2.2 1.8 Diff (mean) -0.9 -0.8 -1.0 -1.2 -1.4 p value versus 0.93 0.31 0.02 < 0.0001 placebo Responders 28 47% 47% 50% 53% 71% day % 0.94 0.55 0.27 < 0.0001 p value versus placebo A post-hoc, unplanned, subgroup analysis (of CS29, to 28 days) by sex suggested that women achieved a similar response to men at lower doses. This may be related to size/weight. Women Table 5: Post-hoc, subgroup analysis (of CS29, to 28 days) of women Nocturnal Placebo 10 µg 25 µg 50 µg 100 µg voids (n = 66) (n = 73) (n = 65) (n = 71) (n = 66) Day 28 (mean) 2.5 2.2 2.1 1.9 1.5 Diff (mean) -0.9 -1.2 -1.2 -1.2 -1.5 p value versus 0.07 0.02 0.01 < 0.0001 placebo
Phases Phase 1 28 days Phase 2 6 extension (double blind) Patients on active treatment continued on same treatment Patients on placebo were re-randomised to one of the 4 active treatment groups CS31 was an open label extension of Part 2 of CS29. Patients on 10 µg were re-randomised Measurement of primary endpoint (nocturnal voids) Nocturnal voids were recorded in a diary on 3 consecutive 24 hour periods at baseline and during the first four weeks of the study (Days 8, 15, 22, 28). The pre-specified time point was 28 days. Results Table 4: Results Study CS29; Nocturnal voids Nocturnal voids Placebo (n = 156) 10 µg (n = 155) 25 µg (n = 152) 50 µg (n = 148) 100 µg (n = 146) Baseline (mean) 3.3 3.2 3.4 3.4 3.2 Day 28 (mean) Diff (mean) p value versus placebo 2.4 -0.9 2.4 -0.8 0.93 2.4 -1.0 0.31 2.2 -1.2 0.02 1.8 -1.4 < 0.0001 Responders 28 day % p value versus placebo 47% 47% 0.94 50% 0.55 53% 0.27 71% < 0.0001 A post-hoc, unplanned, subgroup analysis (of CS29, to 28 days) by sex suggested that women achieved a similar response to men at lower doses. This may be related to size/weight. Women Table 5: Post-hoc, subgroup analysis (of CS29, to 28 days) of women Nocturnal voids Placebo (n = 66) 10 µg (n = 73) 25 µg (n = 65) 50 µg (n = 71) 100 µg (n = 66) Day 28 (mean) Diff (mean) p value versus placebo 2.5 -0.9 2.2 -1.2 0.07 2.1 -1.2 0.02 1.9 -1.2 0.01 1.5 -1.5 < 0.0001
auspar-desmopressin-181127-cer.docx