Table 1 Study 205 Demographic Profile of
Primary Study Sample (N=575)* |
||||||||
|
Age (Years) |
Gender |
Race |
Mass (kg) |
||||
Treatment
Group |
Mean |
Range |
Male N (%) |
Female N (%) |
White N (%) |
Non-White N (%) |
Mean |
Range |
Bupropion
Sustained-Release 100 mg/d |
39 |
18.79 |
48 (42%) |
66 (58%) |
100 (88%) |
14 (12%) |
79.5 |
45.4-133.3 |
Bupropion
Sustained-Release 200 mg/d |
41 |
20-82 |
38 (32%) |
80 (68%) |
105 (90%) |
12 (10%) |
79.4 |
47.6-155.1 |
Bupropion
Sustained-Release 300 mg/d |
40 |
20-76 |
38 (33%) |
77 (67%) |
106 (92%) |
9 (8%) |
79.0 |
49.9-167.8 |
Bupropion
Sustained-Release 400 mg/d |
40 |
20-63 |
50 (43%) |
65 (57%) |
98 (85%) |
17 (15%) |
78.7 |
44.0-150.1 |
Placebo |
40 |
21-77 |
43 (38%) |
70 (62%) |
95 (84%) |
18 (16%) |
80.1 |
47.6-165.5 |
*The
sponsor excluded 27 of the 602 patients randomly assigned to a treatment
condition at baseline from this table because no treatment phase assessments
were available.
Table 2 Study 205 Patient Completion Rates |
||||||||||
Treatment Groups |
Number Randomized |
Intent-to- Treat Sample |
Completers at Week [n (%)] |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
|||
BUP
SR 100 |
119 |
107 |
107 (100%) |
103 (96%) |
102 (95%) |
89 (83%) |
85 (79%) |
86 (80%) |
82 (77%) |
76 (71%) |
BUP
SR 200 |
120 |
106 |
106 (100%) |
100 (94%) |
95 (90%) |
90 (85%) |
85 (80%) |
83 (78%) |
80 (75%) |
74 (70%) |
BUP
SR 300 |
120 |
106 |
106 (100%) |
98 (92%) |
81 (76%) |
80 (75%) |
77 (73%) |
71 (67%) |
69 (65%) |
66 (62%) |
BUP
SR 400 |
119 |
108 |
108 (100%) |
94 (87%) |
88 (81%) |
83 (77%) |
77 (71%) |
75 (69%) |
72 (67%) |
70 (65%) |
Placebo |
124 |
109 |
190 (100%) |
107 (98%) |
102 (94%) |
90 (83%) |
87 (80%) |
83 (76%) |
82 (75%) |
75 (69%) |
Bupropion
Sustained –Release Clinical Review 54
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