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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