Telmisartan randomised assessment study in ACE intolerant subjects with cardiovascular disease
ISRCTN | ISRCTN75807641 |
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DOI | https://doi.org/10.1186/ISRCTN75807641 |
ClinicalTrials.gov number | NCT00153101 |
Secondary identifying numbers | N/A |
- Submission date
- 18/12/2002
- Registration date
- 18/12/2002
- Last edited
- 21/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Salim Yusuf
Scientific
Scientific
Population Health Research Institute
McMaster University
Hamilton General Hospital
McMaster Clinic
237 Barton St E
Hamilton
Ontario L8L 2X2
Canada
Phone | +1 (0)905 527 4322 ext 44515 |
---|---|
yusufs@mcmaster.ca |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease |
Study acronym | TRANSCEND |
Study objectives | 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). |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Congestive heart failure |
Intervention | Telmisartan (an angiotensin II blocker) or matched placebo. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Telmisartan |
Primary outcome measure | 1. Cardiovascular death 2. Non-fatal myocardial infarction 3. Non-fatal stroke 4. Hospitalisation for congestive heart failure |
Secondary outcome measures | 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 |
Overall study start date | 01/01/2004 |
Completion date | 01/01/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 6000 |
Key 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. Without proteinuria 4. Who are intolerant of ACE inhibitors |
Key exclusion criteria | Does not comply with the above criteria |
Date of first enrolment | 01/01/2004 |
Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- 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
- Türkiye
- Ukraine
- United Arab Emirates
- United Kingdom
- United States of America
Study participating centre
Hamilton General Hospital
Hamilton
Ontario L8L 2X2
Canada
Ontario L8L 2X2
Canada
Sponsor information
Boehringer Ingelheim (Canada) Ltd
Industry
Industry
Research and Development
2100 Cunard Street
Laval (Québec)
H7S 2G5
Canada
Phone | +1 (0)450 682 4640 |
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info@lav.boehringer-ingelheim.com | |
Website | http://www.boehringer-ingelheim.ca/ |
https://ror.org/031sxg258 |
Funders
Funder type
Industry
Boehringer Ingelheim (Canada) Ltd
No information available
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Basic results | No | No | |||
Protocol article | protocol | 01/07/2004 | Yes | No | |
Other publications | baseline data | 01/04/2005 | Yes | No | |
Results article | results | 20/03/2007 | Yes | No | |
Results article | results | 27/09/2008 | Yes | No | |
Results article | results | 06/10/2009 | Yes | No | |
Results article | results | 30/03/2010 | Yes | No |
Editorial Notes
21/03/2016: added link to results - basic reporting.