5.0
Description of Clinical Data Sources
5.1
Primary Development Program
5.1.1
Study Type and Design/Patient Enumeration
Table
5.1.1 enumerates participants exposed to medication in the various phases of
the sponsor’s development program for the sustained-release formulation of
bupropion. A total of 693 patients
exposed to bupropion sustained-release for whom treatment phase assessements [assessments]
were available provided data for the integrated Phase 2-3 safety and
efficacy database. This database
reflects data collected through February 25, 1993. In addition, 3100 patients were exposed to bupropion
sustained-release in a Phase 3 study designed to address incidence of
seizures. Appendix 5.1.1 lists all the
studies in the sponsor’s clinical development program, with a brief description
of each.
|
Table 5.1.1 Summary of All Studies |
||
|
Pools
by Study Design |
Enumeration by Treatment
Group |
|
|
|
Bupropion
sustained-release |
Placebo |
|
Phase
1 (CLINICAL PHARMACOLOGY) |
||
|
Single
Dose |
96 |
0 |
|
Multiple
Dose |
36 |
0 |
|
SUBTOTAL |
132 |
0 |
|
Phases
2-3 (ANTIDEPRESSANT & SEIZURE INCIDENCE STUDIES) |
||
|
Placebo-Controlled |
693 |
235 |
|
Open |
3100 |
0 |
|
SUBTOTAL |
3793 |
235 |
|
SINGLE
DOSE |
96 |
0 |
|
MULTIPLE
DOSE TOTAL |
3829 |
235 |
|
GRAND
TOTAL |
3925 |
235 |
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