PARIS, Jan. 17 /PRNewswire-FirstCall/ -- Sanofi-Synthelabo
(EURONEXT: SNYNF, NYSE: SNY) announced today that the company has decided to
discontinue the ANDROMEDA study, after considering the recommendations of the
Steering Committee and the independent Data Safety and Monitoring Board (DSMB)
of this study.
ANDROMEDA (Antiarrhythmic trial with Dronedarone in Moderate to severe CHF
Evaluating morbidity Decrease) is a double blind, placebo-controlled study
evaluating dronedarone in high risk patients with congestive heart failure and
ventricular dysfunction. The study was conducted in Denmark, Hungary, Norway,
Poland, Sweden and The Netherlands. A total of 627 patients, out of the 1,000
planned, were already enrolled in the study.
On January 16, 2003, following an interim safety analysis, the DSMB raised
the issue of a potential excess risk of death in patients on active treatment.
Before considering a new protocol, an in-depth analysis and a clear
interpretation of the present data are necessary.
Dronedarone is a compound which is currently assessed as a potential
antiarrhythmic drug. The Phase III clinical program comprises:
- Two pivotal trials in the maintenance of sinus rhythm in patients with
atrial fibrillation EURIDIS (in Europe) and ADONIS (in North America,
South America, Australia and South Africa)
- One morbidity-mortality study in high risk patients: ANDROMEDA
Recruitment in these two pivotal trials, EURIDIS and ADONIS, is now
completed. These studies are currently ongoing and are closely supervised by
their respective Steering Committees and Data Safety and Monitoring Boards.
This release contains statements that constitute forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. These statements are based on management's current expectations
or beliefs and are subject to a number of uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements: the ability of Sanofi-Synthelabo to expand its
presence profitability in the United States; the success of Sanofi-Synthelabo
research and development programs; the ability of Sanofi-Synthelabo to protect
its intellectual property rights; and the risks associated with reimbursement
of healthcare costs and pricing reforms, particularly in the United States and
France. Investors and security holders may obtain a free copy of documents
filed by Sanofi-Synthelabo with the U.S Securities and Exchange Commission at
www.sec.gov or directly from Sanofi-Synthelabo.
Media Contact: Jean-Marc Podvin; Vice President, Media Relations:
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