Worldwide Study to Evaluate New Approach to Preventing Cardiovascular Disease in Ace Inhibitor-Intolerant Patients - Largest Cardiovascular Protection Trial Ever Conducted in This Patient Population Will Parallel Landmark 'ONTARGET' Study - MILAN, June 15 /PRNewswire-AsiaNet/ -- Boehringer Ingelheim today 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(R) (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. 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, University Erlangen Nurnberg. "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 comparable in scope to the data produced by 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 initiated 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. " Side effects associated with ACE inhibitors include intolerable cough, renal dysfunction and orthostatic hypotension. "These side effects can result in discontinuation of the medication, therefore it is particularly important for ACE inhibitor-intolerant patients to have a safe and effective therapeutic option," said Dr. Schmieder. TRANSCEND Trial Protocol TRANSCEND is a double-blind, parallel-group study that will begin in 2001 and will be completed in approximately 5.5 years. It will run simultaneously with ONTARGET and will assess the ONTARGET study objectives for treatment with 80 mg. versus placebo in patients who are intolerant to ACE inhibitors. The primary objective for the study is the comparison of treatments with respect to the composite endpoint of cardiovascular mortality, stroke, acute myocardial infarction and hospitalization for congestive heart failure. The secondary objective for TRANSCEND is the comparison of treatment with respect to incidence of revascularization procedures, newly diagnosed diabetes, dementia, new onset atrial fibrillation and microvascular complications of diabetes. Patients over the age of 55 with a history of coronary artery disease, stroke, peripheral vascular disease or type I or II diabetes with end-organ damage may be eligible for enrollment. Heart failure patients are excluded from the study. About ONTARGET ONTARGET will assess the efficacy of the angiotensin II receptor blocker MICARDIS(R) alone, and in combination with the ACE inhibitor ramipril, compared to the efficacy of ramipril alone. The composite cardiovascular endpoint will be the reduction of risk of cardiovascular mortality, stroke, myocardial infarction and hospitalization for CHF. This large international study of approximately 23,400 patients will be conducted in 39 countries. The Boehringer Ingelheim group of companies, headquartered in Ingelheim, Germany, is one of the 20 leading pharmaceutical corporations in the world. In 2000, it posted revenues of more than EUR 6 billion. Boehringer Ingelheim, which has some 140 affiliated companies worldwide, focuses on human pharmaceuticals and animal health. The human pharmaceuticals business, which accounts for 95% of sales, is comprised of prescription medicines, consumer health care products and chemicals and biopharmaceuticals for industrial customers. Research and development, production, and distribution facilities are located around the globe. In 2000, Boehringer Ingelheim spent almost EUR 1.0 billion on R&D, equivalent to 16% of net sales. For more information on Boehringer Ingelheim please see also the Internet webpage http://www.boehringer-ingelheim.com For more information on ONTARGET and TRANSCEND, please visit http://www.ontarget-micardis.com SOURCE: Boehringer Ingelheim GmbH CONTACT: Tammie Coyman of GCI Healthcare, 212-537-8107, [email protected], or Judith von Gordon, Corporate Public Relations Division of Boehringer Ingelheim GmbH, + 49-6132-773582 Web site: http://www.boehringer-ingelheim.com