Clinical Trial Results:
A 2-year extension to study 2203, partially randomized, double-blind, placebo-controlled in the first year and open label in the second year, to assess
the safety of the dose of AAE581 selected for phase III development in postmenopausal osteoporosis, and the offset of effect on biomarkers and BMD
Summary
|
|
EudraCT number |
2004-002952-33 |
Trial protocol |
SK AT IT ES |
Global completion date |
03 May 2006
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
27 Aug 2016
|
First version publication date |
27 Aug 2016
|
Other versions |
|
Summary report(s) |
CAAE581A2203E1.CTR.9Aug2016 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.