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B-GT/16: Regulatory and clinical data
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
Title |
A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina |
|
Company or sponsor |
Schering N.V./S.A. |
|
Pharmaceutical study code |
305602 |
|
Phase |
IIb/III |
|
Unicenter/multicenter study |
multicenter |
|
| Clinical data | see table 2 | |
Installation |
Universitair Ziekenhuis Gasthuisberg, Leuven |
O.-L.-Vrouwziekenhuis, Aalst |
Authorisation procedure |
contained use, new operation (see relevant regulation) |
contained use, first use (see relevant regulation) |
Application number |
SBB 219 2002/0866 |
SBB 219 2002/1499 |
User(s) |
Prof. S. Janssens and Dr. J. Dens |
Dr. J. Bartunek and Dr. W. Wijns |
Receipt date |
11/07/2002 |
05/12/2002 |
Biosafety Council meeting date |
- |
- |
Authorisation date |
14/07/2003 |
- |
Status |
enrolment of patients stopped on 29/01/2004 |
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