Boehringer completes stroke drug trial recruitment

FRANKFURT, Jan 17 (Reuters) - Boehringer Ingelheim has completed the enrolment of patients to evaluate the efficacy and safety of its experimental drug dabigatran for stroke prevention in patients with irregular heartbeat, it said on Thursday.

The trial is comparing two doses of oral dabigatran etexilate with the current standard therapy, warfarin, one of the world's most prescribed medicines.

The late-stage trial, referred to as RE-LY, is the largest for this indication, with 18,114 patients in 1,000 centres in 44 countries enrolled between December 2005 and December 2007.

Currently, over 10,000 patients have been treated for at least six months, with final study results expected to be reported in early 2009, the unlisted Boehringer said.

"Patient enrolment in RE-LY has exceeded our original expectations by far," said Salim Yusuf, Professor of Epidemiology and Cardiology and head of the study coordinating centre at McMaster University in Hamilton, Canada.

Warfarin is sold under the brand name Coumadin by Bristol-Myers Squibb Co (BMY.N) and also by various generic drugs companies.

Dabigatran has been proved to be as effective as injections of Sanofi-Aventis's (SASY.PA) Lovenox in preventing blood clots after hip surgery.

The drug is also a potential rival to Bayer's BAYG.DE big new drug hope rivaroxaban, which has proved superior to Lovenox in a late-stage study in the same indication.

Bayer and Boehringer have submitted their products to European authorities for approval in a first indication.

Dabigatran works by blocking thrombin, a key enzyme for blood clot formation, while Bayer's drug inhibits a protein called Factor Xa. (Reporting by Mantik Kusjanto, editing by Will Waterman)