Boehringer Ingelheim announced plans for the TRANSCEND trial -- Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects with cardiovascular Disease, the largest cardiovascular protection trial ever conducted in patients intolerant to angiotensin converting enzyme (ACE) inhibitors.

The study, announced at the European Society of Hypertension meeting, will examine the effects of the angiotensin II receptor antagonist (ARB) MICARDIS (telmisartan) on this patient population and will enroll approximately 5,000 patients worldwide.

TRANSCEND will parallel the objectives of the ONTARGET cardiovascular protection trial, one of the largest, most ambitious clinical studies to investigate the role of an ARB in the prevention of stroke, myocardial infarction, hospitalization for congestive heart failure (CHF) and cardiovascular death in a combined endpoint. Boehringer Ingelheim is the sole sponsor of TRANSCEND and ONTARGET.

"TRANSCEND will be a significant complement to the ONTARGET trial, a study we anticipate will have a major impact on cardiovascular disease prevention," said Prof. Dr. Roland Schmieder of the University Erlangen Nürnberg. "The goal with TRANSCEND and ONTARGET is to fully understand the potential of ARBs so that physicians can offer an effective and tolerable treatment regimen to the broadest range of patients."

ONTARGET stands for ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial. It is expected to provide data on an ARB in a setting comparable to the Heart Outcomes Prevention Evaluation (HOPE) trial in 1999. The HOPE trial found that the ACE inhibitor ramipril reduces the combined risk of stroke, myocardial infarction and cardiovascular death by 22 percent. Boehringer Ingelheim announced the ONTARGET study in March.

"TRANSCEND is an important study that examines the effects of an ARB in a much neglected group: individuals who cannot tolerate an ACE inhibitor," stated ONTARGET Lead Investigator Professor Salim Yusuf, Hamilton, Canada. "At present, many physicians extrapolate and assume that an ARB will be effective in this group. It will be very important to get hard evidence and TRANSCEND will provide this. "