Endpoint/Factors | MINICHAL mood domain | MINICHAL somatic domain | MINICHAL total score | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | Difference between week 54 and baseline | p value | Baseline | Difference between week 54 and baseline | p value | Baseline | Difference between week 54 and baseline | p value | |
Age class | <0.0001 | 0.0058 | <0.0001 | ||||||
<=60 years | 5.34 (4.38) | −2.00 (4.21) | 2.51 (2.68) | −0.80 (2.46) | 7.80 (6.24) | −2.80 (5.67) | |||
>60 years | 5.63 (4.48) | −1.40 (4.27) | 2.81 (2.61) | −0.70 (2.45) | 8.38 (6.16) | −2.00 (5.66) | |||
Gender | 0.0151 | 0.0004 | 0.0045 | ||||||
Male | 4.74 (4.10) | −1.60 (4.00) | 2.18 (2.34) | −0.70 (2.22) | 6.88 (5.66) | −2.30 (5.38) | |||
Female | 6.06 (4.59) | −1.90 (4.43) | 2.99 (2.86) | −0.90 (2.64) | 8.99 (6.51) | −2.80 (5.92) | |||
BMI | 0.0063 | ||||||||
<=25 kg/m2 | 2.32 (2.50) | −0.80 (2.03) | |||||||
>25 to < =30 kg/m2 | 2.33 (2.53) | −0.80 (2.40) | |||||||
= > 30 kg/m2 | 2.89 (2.76) | −0.80 (2.58) | |||||||
Diabetes | 0.0326 | ||||||||
Yes | 5.80 (4.70) | −1.40 (4.52) | |||||||
No | 5.38 (4.37) | −1.90 (4.19) | |||||||
Country (region) | <0.0001 | <0.0001 | |||||||
Western-central countries | 4.56 (4.66) | −1.80 (4.42) | 6.70 (6.45) | −2.30 (5.97) | |||||
Eastern countries | 5.90 (4.22) | −1.80 (4.14) | 8.68 (5.98) | −2.70 (5.52) | |||||
Amount of concomitant medication | 0.0387 | <0.0001 | 0.0002 | ||||||
0 | 5.79 (4.27) | −2.20 (4.30) | 2.43 (2.42) | −1.00 (2.05) | 8.21 (5.77) | −3.20 (5.24) | |||
1-2 | 5.44 (4.32) | −1.90 (3.92) | 2.32 (2.55) | −0.80 (2.38) | 7.69 (6.00) | −2.70 (5.25) | |||
3-4 | 5.15 (4.22) | −1.80 (4.02) | 2.73 (2.78) | −0.80 (2.53) | 6.00 (5.06) | −2.50 (5.70) | |||
5-6 | 5.38 (4.37) | −1.30 (4.40) | 2.91 (2.78) | −0.70 (2.55) | 8.28 (6.22) | −2.00 (5.97) | |||
= > 7 | 5.61 (5.08) | −1.50 (5.01) | 3.01 (2.75) | −0.60 (2.85) | 8.57 (7.00) | −2.00 (6.77) | |||
Achieved hypertension control by week 54 | 0.002 | 0.011 | |||||||
Yes | 2.44 (2.59) | −0.80 (2.37) | 7.75 (6.13) | −2.70 (5.62) | |||||
No | 3.13 (2.85) | −0.70 (2.77) | 8.67 (6.33) | −2.20 (5.90) | |||||
Treatment in Period 6 | 0.0158 | 0.0012 | 0.024 | ||||||
OM20/AML5/HCTZ12.5 | 5.19 (4.24) | −1.90 (4.23) | 2.39 (2.59) | −0.80 (2.32) | 7.48 (5.99) | −2.60 (5.59) | |||
OM40/AML5/HCTZ12.5 | 5.94 (5.05) | −1.40 (4.80) | 3.02 (3.04) | −1.00 (3.02) | 8.93 (7.09) | −2.40 (6.81) | |||
OM40/AML5/HCTZ25 | 5.94 (4.58) | −2.00 (4.12) | 2.67 (2.58) | −0.90 (2.49) | 8.59 (6.22) | −2.90 (5.50) | |||
OM40/AML10/HCTZ12.5 | 5.69 (4.39) | −1.70 (3.90) | 3.19 (2.95) | −0.50 (2.77) | 8.95 (6.46) | −2.30 (5.88) | |||
OM40/AML10/HCTZ25 | 4.83 (3.89) | −1.20 (3.88) | 2.86 (2.43) | −0.50 (2.25) | 7.67 (5.41) | −2.00 (4.73) | |||
Baseline value of respective endpoint | <0.0001 | <0.0001 | <0.0001 | ||||||
SeSBP changes from baseline to week 54 | 0.0089 | 0.0002 | 0.0006 | ||||||
SeDPB changes from baseline to week 54 | 0.1089 | 0.0080 | 0.0273 |