AD5.1.1 Study Type and Design/Patient Enumeration
Table AD5.1.1 enumerates participants exposed to
medication in the various phases of the sponsor’s development program for the
sustained-release formulation of bupropion.
Protocol 212 was an eight-week double-blind, parallel group, six-center,
fixed dose outpatient trial of bupropion sustained-release and placebo in
subjects with major depression. A total
of 294 patients exposed to bupropion sustained-release and 150 patients exposed
to placebo for whom treatment phase assessments were available provided data
for this addendum. Six of these 444
patients were excluded from the protocol analysis because inadequate treatment
phase assessments were conducted. The
study had three levels. Among the
patients with treatment phase assessments, 148 patients were assigned to
receive placebo bid, 146 patients were assigned to receive 150 mg bupropion
sustained-release qam and placebo qpm, and 144 patients were assigned to
receive 300 mg bupropion sustained-release, divided between qam and placebo qdm
doses. This database reflects data
collected through November 1, 1994.
|
Table
AD5.1.1 Summary
of All Studies |
||
|
Pools by Study Design |
Enumeration by Treatment
Group |
|
|
Bupropion
sustained-release |
Placebo |
|
|
Phase 2-3 Protocol 212 |
294 |
150 |
|
All Phase 2-3 Studies |
4087 |
385 |
|
SINGLE DOSE TOTAL |
96 |
0 |
|
MULTIPLE DOSE TOTAL |
4123 |
385 |
|
GRAND TOTAL |
4219 |
385 |
AD5.1.2 Demographics
Table AD5.1.2.2 presents the demographic information
for the population in protocol 212.
|
Table
AD5.1.2.2 Demographic
Profile for Phase 2-3 Protocol 212 |
|||
|
Parameter |
Bupropion (N=294) |
Placebo (N=150) |
|
|
Age (years) |
Mean |
38 |
38 |
|
Range |
18-80 |
18-73 |
|
|
Gender |
Male |
36% |
34% |
|
Female |
64% |
66% |
|
|
Race |
White |
91% |
95% |
|
Black |
5% |
1% |
|
|
Other |
3% |
4% |
|
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