ASIANET: Landmark Worldwide 'ONTARGET' Study of Approximately 28,000 Patients

Evaluate the Role of a New Therapeutic Approach In Prevention Of

Cardiovascular Disease

Study at Up to 700 Sites Will Build On Landmark Hope Trial

INGELHEIM, Germany, March 13 /PRNewswire-AsiaNet/ -- Boehringer Ingelheim today announced plans for the ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET), one of the largest, most ambitious clinical studies to investigate the role of an angiotensin II receptor blocker in the prevention of stroke, myocardial infarction, and cardiovascular death. ONTARGET will involve some 28,000 patients from approximately 700 sites worldwide for an observation period of up to five years.

ONTARGET is expected to provide data on an angiotensin II receptor blocker (ARB) comparable in scope to the data on ramipril produced by the Heart Outcomes Prevention Evaluation (HOPE) trial in 1999. The HOPE trial found that ramipril reduces the combined risk of stroke, myocardial infarction and cardiovascular death by 22 percent.

"ONTARGET will potentially have a major impact on disease prevention, providing physicians with new therapeutic options to prevent cardiovascular disease," said Dr. Andreas Barner, member of the Board of Managing Directors of Boehringer Ingelheim, responsible for Research, Development and Medicine.

ONTARGET will assess the efficacy of the angiotensin II receptor blocker MICARDIS(R) (telmisartan) alone, and in combination with the angiotensin converting enzyme (ACE) inhibitor ramipril, and will compare these to the efficacy of ramipril alone. Endpoints will include the reduction of risk of cardiovascular mortality, stroke, myocardial infarction and hospitalisation for congestive heart failure (CHF).

"While ramipril has been shown to be important in the prevention of cardiovascular events, angiotensin receptor blockers such as MICARDIS(R) may be better tolerated and may provide similar benefits as those already demonstrated with ramipril. However, it is important to confirm this in a prospective large trial which the ONTARGET study would do," said ONTARGET Lead Investigator, Prof. Salim Yusuf, Hamilton, Canada. "More exciting perhaps is the idea that combination therapy of an angiotensin receptor blocker, when added to an ACE inhibitor, will offer a greater degree of cardiovascular protection than an ACE inhibitor alone. Both these hypotheses will be tested in this large international study of approximately 28,000 patients in 35 countries."

Trial Protocol

ONTARGET is a multi-center, double-blind, randomized global trial that will involve patients from Asia, Australia, Europe, North and South America, and South Africa. Patients will be divided into three treatment groups. One group will receive MICARDIS(R) daily, another group will receive ramipril daily, and the third group will receive the combination of MICARDIS(R) plus ramipril daily.

As ONTARGET will potentially have a major impact on disease prevention, an international group of highly reputed scientists are already involved in the protocol and the conduct of the trial; they are (in alphabetical order), Craig Anderson, NZ; Peter Meredith, UK; Roland Schmieder, Germany; Peter Sleight, UK; Thomas Unger, Germany; Michael Weber, USA; Salim Yusuf, Canada.

Patient enrolment will begin in the second half of 2001, and the study is expected to be completed in 2006. Patients in the study will be at least 55 years of age with a history of coronary artery disease, stroke, peripheral vascular disease or diabetes with at least one other cardiovascular risk factor, including hypertension, elevated total cholesterol, low HDL- cholesterol levels, cigarette smoking or microalbuminuria (an imbalance of serum proteins in the urine).

The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical firms in the world and reported revenues of almost DEM 10 billion in 1999.

Boehringer Ingelheim has some 140 affiliated companies world-wide. The focus is on the human pharmaceutical as well as on the animal health business. The human pharmaceutical business, which is responsible for 92% of sales, includes mainly prescription medicines and products for consumer health care but also for industrial customers (chemicals and biopharmaceuticals).

Substantial research and development, production, and distribution facilities are located around the globe. In 1999 Boehringer Ingelheim spent DEM 1.6 billion on R&D, equivalent to 16% of total sales.

For more information on Boehringer Ingelheim please see also the Internet website http://www.boehringer-ingelheim.com as well as http://www.ontarget-micardis.com.

SOURCE: Boehringer Ingelheim

Editor's Note: If you'd like to learn more about ONTARGET, Boehringer Ingelheim is hosting a symposium entitled " ONTARGET -- A challenging Target for an outcome trial; Angiotensin II and vascular disease: a link between endothelial dysfunction, atherosclerosis and hypertension?" on March 17th at the ACC meeting. The symposium will take place at: UNIVERSAL Orlando- Herc & Zena Studio Universal Studios Orlando, Florida, USA 3:00pm - 4:30pm

CONTACT: In Australia, Mr. Max Henry or Mr. Barnes both of Boehringer Ingelheim Pty, Ltd., 2-8875-8800, or In China, Mr. Peter Bohnekamp of Boehringer Ingelheim Intern. Trading, 21-5888-2200; or In Indonesia, Mr. Scobie of BI Pharma Services Indonesia, 21-5732375; or In Japan, Mr. Kozo Taneda of Nippon Boehringer Ingelheim Co. Ltd., 727-93 8351; or In Malaysia, Mr. Tan or Ms. Govindasamy of Boehringer Ingelheim Div., Diethelm Ingelheim Div., Diethelm Malysia Sdn. Bhd. 2nd Floor, Wisma UEP Jalan, USJ 10/1A Pusat Perniagaan USJ10 46720 Subang Jaya Selangor Darul Ehsan Malaysia; or In New Zealand, Mr. John Barnes of Boehringer Ingelheim, 9-262-13-56; or In Philippines, Mr. Stefan Kilian of Boehringer Ingelheim (Phil) Inc., 2-8670800; or In Singapore, Mr. David Townley of Boehringer Ingelheim Intern. Singapore, 391-8150; or In South Korea,Mr. Michael Richter of Boehringer Ingelheim, 2-7090002; or In Taiwan, Mr. David Lin of Boehringer Ingelheim Taiwan Ltd, 22-503-26-36; or In Vietnam, Mr. Andrew Eve of Boehringer Ingelheim Intern. GmbH, ? 823 6919

Web site: http://www.boehringer-ingelheim.com

http://www.ontarget-micardis.com

• ข่าวCardiovascular Disease
• ข่าวBoehringer Ingelheim
• ข่าวTelmisartan
• ข่าวPRNewswire
• ข่าวo:heal