Ongoing telmisartan alone or in combination with ramipril global endpoint trial

ISRCTN	ISRCTN16228603
DOI	https://doi.org/10.1186/ISRCTN16228603
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

Study website

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 design	Prevention randomised double-blind active-controlled parallel assignment
Primary study design	Interventional
Secondary study design	Randomised parallel 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	ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial
Study acronym	ONTARGET
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Congestive heart failure
Intervention	Ramipril (an ACE inhibitor), telmisartan (an angiotensin II blocker), their combination, or matched placebos.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Telmisartan, ramipril
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	01/01/2003
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	31546
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. 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
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/01/2003
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Argentina
Australia
Austria
Belgium
Brazil
Canada
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	+1 450 682 4640
Email	info@lav.boehringer-ingelheim.com
Website	http://www.boehringer-ingelheim.ca/
"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 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	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	10/04/2008	Yes	No
Results article	results	16/08/2008	Yes	No
Results article	results	06/10/2009	Yes	No
Results article	results	30/03/2010	Yes	No
Results article	results	01/03/2014	Yes	No

Editorial Notes

21/03/2016: added link to results - basic reporting.