Telmisartan randomised assessment study in ACE intolerant subjects with cardiovascular disease

ISRCTN ISRCTN75807641
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

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
Email yusufs@mcmaster.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTelmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease
Study acronymTRANSCEND
Study objectivesThis 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) studiedCongestive heart failure
InterventionTelmisartan (an angiotensin II blocker) or matched placebo.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Telmisartan
Primary outcome measure1. Cardiovascular death
2. Non-fatal myocardial infarction
3. Non-fatal stroke
4. Hospitalisation for congestive heart failure
Secondary outcome measures1. 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 date01/01/2004
Completion date01/01/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants6000
Key inclusion criteria1. 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 criteriaDoes not comply with the above criteria
Date of first enrolment01/01/2004
Date of final enrolment01/01/2008

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

Sponsor information

Boehringer Ingelheim (Canada) Ltd
Industry

Research and Development
2100 Cunard Street
Laval (Québec)
H7S 2G5
Canada

Phone +1 (0)450 682 4640
Email info@lav.boehringer-ingelheim.com
Website http://www.boehringer-ingelheim.ca/
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.