Table 2. Summary of Secondary Efficacy End Points (Completers Data Set).
| Efficacy end point |
Mean difference from placebo (90% CI) at day 28 (Periods 1 and 2, completers data set)a |
||||
|---|---|---|---|---|---|
|
ABT-894 |
Atomoxetine | ||||
| 1 mg QD (n=40) | 2 mg QD (n=37) | 4 mg QD (n=36) | 4 mg BID (n=43) | 40 mg BID (n=40) | |
| CAARS:Inv | |||||
| Total score | 2.11 (−2.4, 6.6) | −3.18 (−6.7, 0.3) | 0.23 (−3.2, 3.7) | −6.69 (−10.6, −2.8)* | −7.98 (−12.5, −3.5)* |
| Inattentive score | 0.94 (−1.5, 3.4) | −1.92 (−3.8, −0.1)* | 0.60 (−1.5, 2.7) | −4.08 (−6.4, −1.7)* | −3.89 (−6.3, −1.5)* |
| Hyperactive score | 1.43 (−0.8, 3.7) | −1.24 (−3.0, 0.5) | −0.21 (−1.9, 1.5) | −2.69 (−4.4, −1.0)* | −4.04 (−6.2, −1.8)* |
| ADHD Index | 0.52 (−2.0, 3.0) | −2.01 (−4.4, 0.4) | 0.90 (−1.0, 2.8) | −3.89 (−6.3, −1.5)* | −3.70 (−6.0, −1.3)* |
| CGI-ADHD-S | 0.04 (−0.3, 0.4) | −0.31 (−0.6, 0.0) | −0.06 (−0.3, 0.2) | −0.58 (−1.0, −0.2)* | −0.45 (−0.8, −0.1)* |
| AISRS | |||||
| Total score | 3.19 (−1.2, 7.6) | −2.72 (−6.4, 1.0) | −0.13 (−3.6, 3.4) | −8.07 (−12.2, −3.9)* | −7.18 (−11.5, −2.9)* |
| Inattention score | 1.72 (−0.6, 4.1) | −1.59 (−3.6, 0.4) | 0.81 (−1.2, 2.8) | −4.26 (−6.6, −1.9)* | −3.81 (−6.1, −1.6)* |
| Hyperactivity score | 1.53 (−0.8, 3.8) | −1.11 (−3.0, 0.7) | −0.81 (−2.6, 1.0) | −3.58 (−5.6, −1.6)* | −3.29 (−5.4, −1.2)* |
| CAARS:Self | |||||
| Total score | 3.57 (−0.4, 7.5) | −2.64 (−6.6, 1.3) | −1.13 (−5.2, 2.9) | −7.34 (−11.6, −3.1)* | −7.12 (−10.9, −3.3)* |
| Inattention/memory score | 0.60 (−0.5, 1.7) | −0.23 (−1.2, 0.8) | 0.11 (−0.9, 1.2) | −1.40 (−2.5, −0.3)* | −1.56 (−2.5, −0.6)* |
| Hyperactivity score | 0.93 (−0.2, 2,0) | −0.55 (−1.4, 0.3) | −1.07 (−2.1, −0.0)* | −1.90 (−3.0, −0.8)* | −1.43 (−2.4, −0.4)* |
| Impulsivity score | 0.65 (−0.1, 1.4) | −0.48 (−1.3, 0.3) | −0.02 (−0.9, 0.9) | −0.70 (−1.4, −0.0)* | −1.17 (−1.9, −0.5)* |
| Problem with self-concept score | 0.51 (−0.2, 1.2) | −0.57 (−1.6, 0.5) | 0.33 (−0.7, 1.4) | −1.39 (−2.5, −0.3)* | −0.70 (−1.5, 0.1) |
| ADHD index | 1.84 (−0.0, 3.7) | −1.52 (−3.3, 0.2) | −0.12 (−1.8, 1.5) | −3.37 (−5.3, −1.4)* | −3.00 (−4.9, −1.1)* |
a
LS model-based means are presented; *P<0.05, one-sided tests; from ANCOVA with factors for site, sequence, subject within sequence, period, and treatment, and with baseline score of each period as a covariate.