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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00153101 |
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 CV death, MI, stroke or hospitalization for 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.
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 CV death, MI, stroke or hospitalization for CHF in patients who are intolerant to ACE-I.
Condition | Intervention | Phase |
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Cardiovascular Diseases |
Drug: Telmisartan Drug: Combination of Telmisartan and Ramipril Drug: Ramipril |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Parallel Assignment |
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) |
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Coronary Artery Disease: Previous MI (> 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 PTCA (> 30 days prior to informed consent), or previous multivessel CABG 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:
B. Cardiovascular disease:
C. Other conditions:
Significant renal disease defined as:
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 502.373 |
Study First Received: | September 9, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00153101 |
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: National Agency for Medicines; 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 |
Telmisartan Angiotensin II Ramipril |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |