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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial |
| ISRCTN | ISRCTN16228603 |
| ClinicalTrials.gov identifier | NCT00153101 |
| Public title | ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial |
| Scientific title | |
| Acronym | ONTARGET |
| Serial number at source | N/A |
| Study hypothesis |
To determine if:
1. Telmisartan (Micardis) 80 mg daily and Ramipril (Delix protect) 10 mg daily combination therapy is more effective in reducing the composite endpoint of Cardiovascular (CV) death, Myocardial Infarction (MI), stroke or hospitalisation for Congestive Heart Failure (CHF) compared with Ramipril 10 mg alone; and 2. Telmisartan 80 mg daily is at least as effective as (i.e. not less effective than) Ramipril 10 mg daily A parallel trial "Telmisartan Randomised Assessment Study in Ace Intolerant Subjects with Cardiovascular Disease (TRANSCEND)" is registered with ISRCTN75807641. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Prevention, randomised, double-blind, active controlled, parallel assignment |
| Countries of recruitment | International |
| Disease/condition/study domain | Congestive heart failure |
| Participants - inclusion criteria |
1. Adults greater than or equal to 55 years
2. With a history of symptomatic coronary artery disease, cerebrovascular disease, peripheral vascular disease, or diabetes mellitus 3. Coronary Artery Disease: previous MI (greater than 2 days prior to informed consent), or stable or previous unstable angina (greater than 30 days prior to informed consent) with documented multivessel coronary artery disease or a positive stress test, or multivessel Percutaneous Transluminal Coronary Angioplasty (PTCA) (greater than 30 days prior to informed consent), or previous multivessel Coronary Artery Bypass Graft (CABG) without angina (if surgery performed greater than 4 years prior to informed consent) or with recurrent angina after surgery 4. No definite and specific indication or contraindication for any of the study treatments 5. Written informed consent Other High Risk: 6. Peripheral Arterial Disease: previous limb bypass surgery or angioplasty or amputation, intermittent claudication on history with ankle/arm Blood Pressure (BP) ratio less than 0.8 on at least one side, or significant stenosis by angiography or non-invasive testing 7. Previous stroke 8. Transient Ischaemic Attach (TIA) greater than 7 days and less than 1 year prior to informed consent 9. Diabetes Mellitus (types I or II): with evidence of end-organ damage (retinopathy, Left Ventricular Hypertrophy [LVH], micro- or macro-albuminuria), or any evidence of previous cardiac or vascular disease |
| Participants - exclusion criteria | Does not match inclusion criteria |
| Anticipated start date | 01/01/2003 |
| Anticipated end date | 30/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 31546 |
| Interventions | Ramipril (an ACE inhibitor), telmisartan (an angiotensin II blocker), their combination, or matched placebos. |
| Primary outcome measure(s) |
1. Cardiovascular death
2. Non-fatal myocardial infarction 3. Non-fatal stroke 4. Hospitalisation for congestive heart failure |
| Secondary outcome measure(s) |
1. Newly diagnosed congestive heart failure
2. Cardiovascular revascularisation procedures 3. Newly diagnosed diabetes 4. Cognitive decline (adjudication will be done by a special committee) 5. New onset of atrial fibrillation 6. Nephropathy |
| Sources of funding | Boehringer Ingelheim (Canada) Ltd |
| Trial website | http://www.ontarget-micardis.com/ |
| Publications |
1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15215792
2. 2005 baseline data in http://www.ncbi.nlm.nih.gov/pubmed/15868120 3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17339550 4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18378520 5. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18707986 6. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19770395 7. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20231536 |
| Contact name | Professor Salim Yusuf |
| Address |
Population Health Research Institute
McMaster University Hamilton General Hospital McMaster Clinic 237 Barton St E |
| City/town | Hamilton |
| Zip/Postcode | Ontario L8L 2X2 |
| Country | Canada |
| Tel | +1 905 527 4322 ext 44515 |
| Fax | +1 905 527 7654 |
| yusufs@mcmaster.ca | |
| Sponsor | Boehringer Ingelheim (Canada) Ltd |
| Address |
Research and Development
2100 Cunard Street |
| City/town | Laval (Québec) |
| Zip/Postcode | H7S 2G5 |
| Country | Canada |
| Tel | +1 450 682 4640 |
| Fax | +1 450 682 8434 |
| info@lav.boehringer-ingelheim.com | |
| Sponsor website: | http://www.boehringer-ingelheim.ca/ |
| Date applied | 18/12/2002 |
| Last edited | 01/04/2010 |
| Date ISRCTN assigned | 18/12/2002 |
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