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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00153101 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases |
Drug: Telmisartan Drug: Combination of Telmisartan and Ramipril Drug: Ramipril |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment Primary Purpose: Prevention |
| Official Title: | 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. |
| Enrollment: | 31546 |
| Study Start Date: | November 2001 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations
Show 732 Study Locations| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00153101 History of Changes |
| Obsolete Identifiers: | NCT00034931 |
| Other Study ID Numbers: | 502.373 |
| Study First Received: | September 9, 2005 |
| Results First Received: | June 15, 2009 |
| Last Updated: | April 11, 2011 |
| Health Authority: | Argentina: National Administration of Medicines, Food and Medical Technology; Australia: Responsilble Ethics Committee; Austria: Ministry for Social Security and Generations; Belgium: Federal Agency for Medicines and Health Products; Brazil: National Health Surveillance Agency; Canada: Health Canada; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control (SUKL); Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: AFFSAPS; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Greece: HELLENIC REPUBLIC MINISTRY OF HEALTH AND WELFARE NATIONAL ORGANISATION OF MEDICINES (EOF); Hong Kong: Dept. of Health, Hong Kong; Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest; Ireland: The Irish Medicines Board; Italy: Comitato Etico delle Aziende Sanitarie della Regione Umbria; Korea, Republic of: Korea Food and Drug Administration (KFDA); Malaysia: Drug Control Authority; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); New Zealand: Multicentre Ethics Committee/Medsafe; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Bureau of Pharmaceutical Affairs, Department of Health; Poland: CEBK, Warsaw; Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Centre of Drug Administration; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; South Africa: Medicines Control Council; Spain: Ministry of Health; Sweden: Medical Product Agency; Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products); Taiwan: Dept. of Health, Executive Yuan, Taiwan; Thailand: Bureau of Pharmaceutical Affairs, Department of Health; Turkey: Ministry of Health Central Ethics Committee; Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine; United Arab. Emirates: Medical Affairs Department of Health and Medical Services, General Authority Health Services, Ministry of Health for Northern Emirates; United States: Food and Drug Administration |
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Cardiovascular Diseases Ramipril Telmisartan Angiotensin Receptor Antagonists Benzoates Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Antifungal Agents Anti-Infective Agents |