DGAP-Adhoc
Bayer Aktiengesellschaft: Phase III ROCKET AF Study of Rivaroxaban meets its primary efficacy endpoint with Comparable Safety vs. Warfarin
Bayer Aktiengesellschaft / Key word(s): Research Update
31.10.2010 20:50
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
Anzeige
Bayer Aktiengesellschaft: Phase III ROCKET AF Study of Rivaroxaban meets
its primary efficacy endpoint with Comparable Safety vs. Warfarin
Leverkusen, Germany, October 31, 2010
Bayer today announced the preliminary results of the pivotal Phase III
ROCKET AF study of rivaroxaban, the full details of which will be presented
at the Late Breaker Session on November 15, 2010, [10:45 am - 10:55 am
CST], at the Scientific Sessions of the American Heart Association (AHA) in
Chicago, USA.
The primary objective of the study was to establish the non-inferiority of
20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal
impairment at screening) compared to dose-adjusted warfarin in patients
with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS
systemic embolism. The primary efficacy endpoint was a composite of
all-cause stroke and non-CNS systemic embolism. The primary safety endpoint
was the composite of major and non-major clinically relevant bleeding
events.
Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted
warfarin. The rates of the composite of major and non-major clinically
relevant bleeding were comparable.
ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared
with vitamin K antagonism for prevention of stroke and Embolism Trial in
Atrial Fibrillation) was an event-driven, prospective, randomized,
double-blind Phase III study in which more than 14,000 patients have been
enrolled from more than 1,100 centers across 45 countries worldwide. The
study was led by the Duke Clinical Research Institute, Durham, North
Carolina, USA, and an international academic executive committee.
Information and Explaination of the Issuer to this News:
Forward-Looking Statements:
This Ad-hoc Statement contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer´s public
reports, which are available on the Bayer website at www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
31.10.2010 20:50 DGAP´s Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
Language: English
Company: Bayer Aktiengesellschaft
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Deutschland
Phone: +49 (0)21430-1
Fax: +49 (0)21430-66328
E-mail: alexander.rosar.ar1@bayer-ag.de
Internet: www.bayer-ag.de
ISIN: DE000BAY0017
WKN: BAY001
Indices: DAX, EURO STOXX 50, Stoxx 50
Listed: Regulierter Markt in Frankfurt (Prime Standard), Berlin,
Stuttgart, Hannover, Hamburg, München, Düsseldorf;
Terminbörse EUREX; Foreign Exchange(s) London, Madrid, SIX
End of Announcement DGAP News-Service
its primary efficacy endpoint with Comparable Safety vs. Warfarin
Leverkusen, Germany, October 31, 2010
Bayer today announced the preliminary results of the pivotal Phase III
ROCKET AF study of rivaroxaban, the full details of which will be presented
at the Late Breaker Session on November 15, 2010, [10:45 am - 10:55 am
CST], at the Scientific Sessions of the American Heart Association (AHA) in
Chicago, USA.
The primary objective of the study was to establish the non-inferiority of
20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal
impairment at screening) compared to dose-adjusted warfarin in patients
with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS
systemic embolism. The primary efficacy endpoint was a composite of
all-cause stroke and non-CNS systemic embolism. The primary safety endpoint
was the composite of major and non-major clinically relevant bleeding
events.
Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted
warfarin. The rates of the composite of major and non-major clinically
relevant bleeding were comparable.
ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared
with vitamin K antagonism for prevention of stroke and Embolism Trial in
Atrial Fibrillation) was an event-driven, prospective, randomized,
double-blind Phase III study in which more than 14,000 patients have been
enrolled from more than 1,100 centers across 45 countries worldwide. The
study was led by the Duke Clinical Research Institute, Durham, North
Carolina, USA, and an international academic executive committee.
Information and Explaination of the Issuer to this News:
Forward-Looking Statements:
This Ad-hoc Statement contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group or subgroup management.
Various known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results, financial
situation, development or performance of the company and the estimates
given here. These factors include those discussed in Bayer´s public
reports, which are available on the Bayer website at www.bayer.com. The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments.
31.10.2010 20:50 DGAP´s Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
Language: English
Company: Bayer Aktiengesellschaft
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Deutschland
Phone: +49 (0)21430-1
Fax: +49 (0)21430-66328
E-mail: alexander.rosar.ar1@bayer-ag.de
Internet: www.bayer-ag.de
ISIN: DE000BAY0017
WKN: BAY001
Indices: DAX, EURO STOXX 50, Stoxx 50
Listed: Regulierter Markt in Frankfurt (Prime Standard), Berlin,
Stuttgart, Hannover, Hamburg, München, Düsseldorf;
Terminbörse EUREX; Foreign Exchange(s) London, Madrid, SIX
End of Announcement DGAP News-Service
Aktuelle Themen
Weitere Artikel des Autors
1 im Artikel enthaltener WertIm Artikel enthaltene Werte