ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
ONTARGET ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial A Large, Simple Randomized Trial of an Angiotensin II Receptor Antagonist (Telmisartan) and an ACE-Inhibitor (Ramipril) in Patients at High Risk for Cardiovascular Events and TRANSCEND Telmisartan Randomized AssessmeNt Study in aCE iNtolerant Subjects With Cardiovascular Disease. A Parallel Study Comparing the Effects of Telmisartan With Placebo and Outcomes in Patients at High Risk for Cardiovascular Events and Intolerant to ACE-I.
The Ongoing Telmisartan Alone and in combination wiht Ramipril Global Endpoint trial (ONTARGET): The primary objectives are to determine if (a) telmisartan 80mg daily and ramipril 10mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular Death (CV) death, Myocardial infarction (MI), stroke or hospitalization for Congestive Heart Failure (CHF) compared with ramipril 10mg alone; and (b) telmisartan 80mg daily is at least as effective as (i.e. not less effective than) ramipril 10mg daily, on this endpoint.
Telmisartan Randomised Assessment Study in Angiotension converting Enzyme inhibitor intolerant subjects with Cardiovascular Disease. (TRANSCEND): The primary objective of the study is to determine if treatment with telmisartan 80mg daily is superior to placebo reducing the composite endpoint of Cardiovascular Death (CV), Myocardial Infarction ( MI)I, stroke or hospitalization for Congestive Heart Failure (CHF) in patients who are intolerant to Angiotension Converting Enzyme inhibitors.
Inclusion Criteria:
Coronary Artery Disease: Previous Myocardial infarction(> 2 days prior to informed consent), or stable or previous unstable angina (> 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (> 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Grafting without angina (if surgery performed > 4 years prior to informed consent) or with recurrent angina after surgery.
Other High Risk:
No definite and specific indication or contraindication for any of the study treatments. Written informed consent.
Exclusion Criteria:
A. Medication use:
NOTE: Patients with known intolerance to Angiotension Converting Enzyme inhibitor intolerance ( ACE-I) can be enrolled in the TRANSCEND study.
B. Cardiovascular disease:
C. Other conditions:
Significant renal disease defined as:
Hepatic dysfunction as defined by the following laboratory parameters: Serum Glutamate Pyruvate Transaminase( SGPT) Alaninaminotransferase (ALT) or Serum Glutamic Oxaloacetic Transaminase (SGOT) Aspartate aminotransferase (AST) > than 4 times upper limit of normal or additional criteria for hepatic impairment the upper limit of normal range, total Bilirubin > 20 umol/L, biliary obstructive disorders.
Uncorrected volume depletion or sodium depletion.
Primary aldosteronism.
Hereditary fructose intolerance.
Any other major non-cardiac illness expected to reduce life expectancy or interfere with study participation.
Patient is simultaneously taking another experimental drug.
Patient with significant disability that precludes regular attendance at clinic for follow-up.
Patient has sufficient disability or other incapacity that precludes regular attendance at clinic for follow-up.
Unable or unwilling to provide written informed consent.
Tuscon, Arizona, United States
Washington D.C., District of Columbia, United States
Oklahoma City, Ohio, United States
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Capital Federal, Argentina
Corones Suárez, Argentina
Woden, Australian Capital Territory, Australia
West Heidelberg, Victoria, Australia
Woluwé-Saint-Lambert, Belgium
Cerqueira César - São Paulo, Brazil
Porto Alegre - Rs, Brazil
Rio de Janeiro - Rj, Brazil
Santa Catalina, Brazil
Vila Clementino, São Paulo, Brazil
Manitoba, Manitoba, Canada
Saint Pierre, Manitoba, Canada
New Westminster, Ontario, Canada
Saint George de Beauce, Quebec, Canada
Ste-Foy, Quebec, Canada
HeBei Province, China
Henan Province, China
Hubei Province, China
ShanDong Province, China
ShanDong Province, China
Frederiksberg C, Denmark
Hilleroed, Denmark
Oulun Kaupunki, Finland
Husseren Wesserlin, France
Saint Martin dHyeres, France
Homburg/Saar, Germany
Goudi/ Athens, Greece
Melissia, Athens, Greece
S. Pietro Vernotico (BR), Italy
Kelantan Darul Naim, Malaysia
Kelantan, Malaysia
Hamiton, New Zealand
Hasting, New Zealand
Otahuhu Auckland, New Zealand
Takapuna Auckland, New Zealand
Gdynia Redlowo, Poland
Kuala Lumpur, Singapore
George East, South Africa
Park Town West, South Africa
Burjasot (Valencia), Spain
Järfälla, Sweden
Dnyepropetrovsk, Ukraine
Dnyepropetrovsk, Ukraine