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ISRCTN
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ISRCTN75807641
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ClinicalTrials.gov identifier
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NCT00153101
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Public title
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Telmisartan Randomised Assessment Study in Ace Intolerant Subjects with Cardiovascular Disease
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Scientific title
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Acronym
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TRANSCEND
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Serial number at source
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N/A
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Study hypothesis
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This parallel trial to ISRCTN16228603 (ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial = ONTARGET) is to determine in angiotensin converting enzyme inhibitor (ACE-I) intolerant patients if telmisartan 80 mg daily is superior to placebo in reducing the composite endpoint of cardiovascular death, myocardial infacrtion (MI), stroke or hospitalisation for congestive heart failure (CHF).
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Korea, South, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States of America
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Disease/condition/study domain
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Congestive heart failure
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Participants - inclusion criteria
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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. Without proteinuria
4. Who are intolerant of ACE inhibitors
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Participants - exclusion criteria
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Does not comply with the above criteria
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Anticipated start date
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01/01/2004
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Anticipated end date
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01/01/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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6000
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Interventions
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Telmisartan (an angiotensin II blocker) or matched placebo.
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Primary outcome measure(s)
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1. Cardiovascular death
2. Non-fatal myocardial infarction
3. Non-fatal stroke
4. Hospitalisation for congestive heart failure
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Secondary outcome measure(s)
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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
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Sources of funding
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Boehringer Ingelheim (Canada) Ltd
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Trial website
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Publications
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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/18757085
5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19770395
6. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20231536
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Contact name
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Dr
Salim
Yusuf
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Address
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Population Health Research Institute
McMaster University
Hamilton General Hospital
McMaster Clinic
237 Barton St E
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City/town
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Hamilton
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Zip/Postcode
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Ontario L8L 2X2
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Country
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Canada
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Tel
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+1 905 527 4322 ext 44515
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Fax
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+1 905 527 7654
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Email
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yusufs@mcmaster.ca
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Sponsor
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Boehringer Ingelheim (Canada) Ltd
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Address
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Research and Development
2100 Cunard Street
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City/town
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Laval (Québec)
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Zip/Postcode
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H7S 2G5
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Country
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Canada
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Tel
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+1 450 682 4640
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Fax
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+1 450 682 8434
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Email
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info@lav.boehringer-ingelheim.com
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Sponsor website:
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http://www.boehringer-ingelheim.ca/
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Date applied
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18/12/2002
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Last edited
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31/08/2011
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Date ISRCTN assigned
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18/12/2002
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