Table 1.
Study 3201 (Bipolar Mania) Least Squares Mean Change from Baseline for Serum Urate for Iloperidone vs Placebo Treatment Groups (μmol/L).
| Visit | Iloperidone | Placebo | LS Mean Difference | p-value |
|---|---|---|---|---|
| LS Mean Change (SE), n | LS Mean Change (SE), n | (95% CI) | ||
| Baseline | 323.0 (77.13), 206 | 328.5 (84.6), 208 | - | - |
| Day 7 | −2.7 (−4.07), 199 | −4.0 (−4.11), 196 | 1.3 (−9.29, 11.88) | =0.8098 |
| Day 14 | 12.6 (−4.28), 173 | −2.7 (−4.24), 186 | 15.3 (4.50, 26.15) | =0.0057 |
| Day 21 | 19.1 (−5.24), 157 | −1.9 (−5.07), 166 | 21.0 (8.91, 33.18) | =0.0007 |
| Day 28 | 27.2 (−4.93), 142 | 0.1 (−4.77), 154 | 27.1 (14.94, 39.20) | <0.0001 |
Baseline shown as mean (SD). LS mean change shown for each evaluation for serum urate in Study 3201 (Bipolar Mania). ANCOVA = Analysis of Covariance. CI = Confidence Interval. LS = Least Squares. SE=Standard Error. SD=Standard Deviation. Baseline is defined as the latest non-missing observation across all the visits in the Screening Phase before the first dose of study medication. LS means, CIs, and p-values are based on ANCOVA model with main effects of treatment group and pooled site, and baseline as a covariate. All p values represent the difference between iloperidone and placebo.