Condition category
Circulatory System
Date applied
18/12/2002
Date assigned
18/12/2002
Last edited
21/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ontarget-micardis.com/

Contact information

Type

Scientific

Primary contact

Dr Salim Yusuf

ORCID ID

Contact details

Population Health Research Institute
McMaster University
Hamilton General Hospital
McMaster Clinic
237 Barton St E
Hamilton
Ontario L8L 2X2
Canada
+1 (0)905 527 4322 ext 44515
yusufs@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00153101

Protocol/serial number

N/A

Study information

Scientific title

ONgoing Telmisartan Alone or in combination with Ramipril Global Endpoint Trial

Acronym

ONTARGET

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.

Ethics approval

Not provided at time of registration

Study design

Prevention randomised double-blind active-controlled parallel assignment

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Congestive heart failure

Intervention

Ramipril (an ACE inhibitor), telmisartan (an angiotensin II blocker), their combination, or matched placebos.

Intervention type

Drug

Phase

Not Applicable

Drug names

Telmisartan, ramipril

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

31546

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/2003

Recruitment end date

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, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States of America

Trial participating centre

Hamilton General Hospital
Hamilton
Ontario L8L 2X2
Canada

Sponsor information

Organisation

Boehringer Ingelheim (Canada) Ltd

Sponsor details

Research and Development
2100 Cunard Street
Laval (Québec)
H7S 2G5
Canada
+1 450 682 4640
info@lav.boehringer-ingelheim.com

Sponsor type

Industry

Website

http://www.boehringer-ingelheim.ca/

Funders

Funder type

Industry

Funder name

Boehringer Ingelheim (Canada) Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00153101

Publication summary

2004 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15215792
2005 baseline data in: http://www.ncbi.nlm.nih.gov/pubmed/15868120
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17339550
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18378520
2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18707986
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19770395
2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20231536
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24191305

Publication citations

  1. Results

    Verdecchia P, Sleight P, Mancia G, Fagard R, Trimarco B, Schmieder RE, Kim JH, Jennings G, Jansky P, Chen JH, Liu L, Gao P, Probstfield J, Teo K, Yusuf S, , Effects of telmisartan, ramipril, and their combination on left ventricular hypertrophy in individuals at high vascular risk in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and the Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease., Circulation, 2009, 120, 14, 1380-1389, doi: 10.1161/CIRCULATIONAHA.109.865774.

  2. Results

    Böhm M, Baumhäkel M, Teo K, Sleight P, Probstfield J, Gao P, Mann JF, Diaz R, Dagenais GR, Jennings GL, Liu L, Jansky P, Yusuf S, , Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials., Circulation, 2010, 121, 12, 1439-1446, doi: 10.1161/CIRCULATIONAHA.109.864199.

  3. Results

    Heerspink HJ, Gao P, Zeeuw Dd, Clase C, Dagenais GR, Sleight P, Lonn E, Teo KT, Yusuf S, Mann JF, The effect of ramipril and telmisartan on serum potassium and its association with cardiovascular and renal events: results from the ONTARGET trial., Eur J Prev Cardiol, 2014, 21, 3, 299-309, doi: 10.1177/2047487313510678.

  4. Teo K, Yusuf S, Sleight P, Anderson C, Mookadam F, Ramos B, Hilbrich L, Pogue J, Schumacher H, , Rationale, design, and baseline characteristics of 2 large, simple, randomized trials evaluating telmisartan, ramipril, and their combination in high-risk patients: the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial/Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease (ONTARGET/TRANSCEND) trials., Am. Heart J., 2004, 148, 1, 52-61, doi: 10.1016/j.ahj.2004.03.020.

  5. Sleight P, The ONTARGET/TRANSCEND Trial Programme: baseline data., Acta Diabetol, 2005, 42 Suppl 1, S50-6, doi: 10.1007/s00592-005-0181-3.

  6. Held C, Gerstein HC, Yusuf S, Zhao F, Hilbrich L, Anderson C, Sleight P, Teo K, , Glucose levels predict hospitalization for congestive heart failure in patients at high cardiovascular risk., Circulation, 2007, 115, 11, 1371-1375, doi: 10.1161/CIRCULATIONAHA.106.661405.

  7. , Yusuf S, Teo KK, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P, Anderson C, Telmisartan, ramipril, or both in patients at high risk for vascular events., N. Engl. J. Med., 2008, 358, 15, 1547-1559, doi: 10.1056/NEJMoa0801317.

  8. Mann JF, Schmieder RE, McQueen M, Dyal L, Schumacher H, Pogue J, Wang X, Maggioni A, Budaj A, Chaithiraphan S, Dickstein K, Keltai M, Metsärinne K, Oto A, Parkhomenko A, Piegas LS, Svendsen TL, Teo KK, Yusuf S, , Renal outcomes with telmisartan, ramipril, or both, in people at high vascular risk (the ONTARGET study): a multicentre, randomised, double-blind, controlled trial., Lancet, 2008, 372, 9638, 547-553, doi: 10.1016/S0140-6736(08)61236-2.

Additional files

Editorial Notes

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