Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo. - Study Results

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment; Primary Purpose: Prevention
Condition:	Cardiovascular Diseases
Interventions:	Drug: Telmisartan Drug: Combination of Telmisartan and Ramipril Drug: Ramipril

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Telmisartan/Ramipril (ONTARGET)	Telmisartan 80mg tablet / Ramipril 10mg tablet One tablet of each at the same time daily
Telmisartan (ONTARGET)	Telmisatan 80mg tablet /Ramipril 10mg placebo tablet One tablet of each at the same time daily
Ramipril (ONTARGET)	Ramipril 10mg tablet / Telmisartan 80mg placebo tablet One tablet of each at the same time daily
Telmisartan (TRANSCEND)	Telmisartan 80mg tablet one tablet daily
Placebo (TRANSCEND)	Telmisartan 80mg placebo tablet one tablet daily

Participant Flow: Overall Study

	Telmisartan/Ramipril (ONTARGET)	Telmisartan (ONTARGET)	Ramipril (ONTARGET)	Telmisartan (TRANSCEND)	Placebo (TRANSCEND)
STARTED	8502	8542	8576	2954	2972
COMPLETED	8485	8524	8561	2946	2962
NOT COMPLETED	17	18	15	8	10
Lost to Follow-up	14	14	12	5	5
Withdrawal by Subject	3	4	3	3	5

Baseline Characteristics

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Reporting Groups

	Description
Telmisartan/Ramipril (ONTARGET)	Telmisartan 80mg tablet / Ramipril 10mg tablet One tablet of each at the same time daily
Telmisartan (ONTARGET)	Telmisatan 80mg tablet /Ramipril 10mg placebo tablet One tablet of each at the same time daily
Ramipril (ONTARGET)	Ramipril 10mg tablet / Telmisartan 80mg placebo tablet One tablet of each at the same time daily
Telmisartan (TRANSCEND)	Telmisartan 80mg tablet one tablet daily
Placebo (TRANSCEND)	Telmisartan 80mg placebo tablet one tablet daily

Baseline Measures

	Telmisartan/Ramipril (ONTARGET)	Telmisartan (ONTARGET)	Ramipril (ONTARGET)	Telmisartan (TRANSCEND)	Placebo (TRANSCEND)	Total
Number of Participants [units: participants]	8502	8542	8576	2954	2972	31546
Age [units: years] Mean ± Standard Deviation	66.4 ± 7.3	66.4 ± 7.1	66.4 ± 7.2	66.9 ± 7.3	66.9 ± 7.4	66.5 ± 7.2
Gender [units: participants]
Female	2250	2250	2331	1280	1267	9378
Male	6252	6292	6245	1674	1705	22168

Outcome Measures

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1. Primary:

ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure [ Time Frame: 56 months ]

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2. Primary:

TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure [ Time Frame: 56 months ]

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3. Secondary:

ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke [ Time Frame: 56 months ]

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4. Secondary:

ONTARGET. Cardiovascular Death [ Time Frame: 56 months ]

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5. Secondary:

ONTARGET. Non-fatal Myocardial Infarction [ Time Frame: 56 months ]

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6. Secondary:

ONTARGET. Non-fatal Stroke [ Time Frame: 56 months ]

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7. Secondary:

ONTARGET. Hospitalization for Congestive Heart Failure [ Time Frame: 56 months ]

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8. Secondary:

ONTARGET. Newly Diagnosed Congestive Heart Failure [ Time Frame: 56 months ]

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9. Secondary:

ONTARGET. Cardiovascular Revascularization Procedure [ Time Frame: 56 months ]

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10. Secondary:

ONTARGET. Newly Diagnosed Diabetes [ Time Frame: 56 months ]

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11. Secondary:

ONTARGET. Cognitive Decline [ Time Frame: 56 months ]

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12. Secondary:

ONTARGET. New Onset of Atrial Fibrillation [ Time Frame: 56 months ]

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13. Secondary:

TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke [ Time Frame: 56 months ]

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14. Secondary:

TRANSCEND. Cardiovascular Death [ Time Frame: 56 months ]

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15. Secondary:

TRANSCEND. Non-fatal Myocardial Infarction [ Time Frame: 56 months ]

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16. Secondary:

TRANSCEND. Non-fatal Stroke [ Time Frame: 56 months ]

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17. Secondary:

TRANSCEND. Hospitalization for Congestive Heart Failure [ Time Frame: 56 months ]

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18. Secondary:

TRANSCEND. Newly Diagnosed Congestive Heart Failure [ Time Frame: 56 months ]

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19. Secondary:

TRANSCEND. Cardiovascular Revascularization Procedure [ Time Frame: 56 months ]

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20. Secondary:

TRANSCEND. Newly Diagnosed Diabetes [ Time Frame: 56 months ]

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21. Secondary:

TRANSCEND. Cognitive Decline [ Time Frame: 56 months ]

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22. Secondary:

TRANSCEND. New Onset of Atrial Fibrillation [ Time Frame: 56 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only non-serious Adverse Events (AE) which lead to discontinuation of study medication were assessed and collected; the frequency was under 5%. Non-serious AEs per se were not assessed or collected.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:

Redon J, Mancia G, Sleight P, Schumacher H, Gao P, Pogue J, Fagard R, Verdecchia P, Weber M, Böhm M, Williams B, Yusoff K, Teo K, Yusuf S; ONTARGET Investigators. Safety and efficacy of low blood pressures among patients with diabetes: subgroup analyses from the ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial). J Am Coll Cardiol. 2012 Jan 3;59(1):74-83.

Mancia G, Schumacher H, Redon J, Verdecchia P, Schmieder R, Jennings G, Yusoff K, Ryden L, Liu GL, Teo K, Sleight P, Yusuf S. Blood pressure targets recommended by guidelines and incidence of cardiovascular and renal events in the Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial (ONTARGET). Circulation. 2011 Oct 18;124(16):1727-36. Epub 2011 Sep 26.

Barzilay JI, Gao P, Rydén L, Schumacher H, Probstfield J, Commerford P, Dans A, Ferreira R, Keltai M, Paolasso E, Yusuf S, Teo K; TRANSCEND Investigators. Effects of telmisartan on glucose levels in people at high risk for cardiovascular disease but free from diabetes: the TRANSCEND study. Diabetes Care. 2011 Sep;34(9):1902-7. Epub 2011 Jul 25.

Tobe SW, Clase CM, Gao P, McQueen M, Grosshennig A, Wang X, Teo KK, Yusuf S, Mann JF; ONTARGET and TRANSCEND Investigators. Cardiovascular and renal outcomes with telmisartan, ramipril, or both in people at high renal risk: results from the ONTARGET and TRANSCEND studies. Circulation. 2011 Mar 15;123(10):1098-107. Epub 2011 Feb 28.

Barzilay JI, Gao P, O'Donnell M, Mann JF, Anderson C, Fagard R, Probstfield J, Dagenais GR, Teo K, Yusuf S; ONTARGET and TRANSCEND Investigators. Albuminuria and decline in cognitive function: The ONTARGET/TRANSCEND studies. Arch Intern Med. 2011 Jan 24;171(2):142-50.

Dans AL, Teo K, Gao P, Chen JH, Jae-Hyung K, Yusoff K, Chaithiraphan S, Zhu J, Lisheng L, Yusuf S; Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial Investigators. In a subgroup of high-risk asians, telmisartan was non-inferior to ramipril and better tolerated in the prevention of cardiovascular events. PLoS One. 2010 Dec 21;5(12):e13694.

Anderson C, Teo K, Gao P, Arima H, Dans A, Unger T, Commerford P, Dyal L, Schumacher H, Pogue J, Paolasso E, Holwerda N, Chazova I, Binbrek A, Young J, Yusuf S; ONTARGET and TRANSCEND Investigators. Renin-angiotensin system blockade and cognitive function in patients at high risk of cardiovascular disease: analysis of data from the ONTARGET and TRANSCEND studies. Lancet Neurol. 2011 Jan;10(1):43-53. Epub 2010 Oct 25.

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; ONTARGET/TRANSCEND Erectile Dysfunction Substudy Investigators. 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 Mar 30;121(12):1439-46. Epub 2010 Mar 15.

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; ONTARGET/TRANSCEND Investigators. 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 Oct 6;120(14):1380-9. Epub 2009 Sep 21.

Sleight P, Redon J, Verdecchia P, Mancia G, Gao P, Fagard R, Schumacher H, Weber M, Böhm M, Williams B, Pogue J, Koon T, Yusuf S; ONTARGET investigators. Prognostic value of blood pressure in patients with high vascular risk in the Ongoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial study. J Hypertens. 2009 Jul;27(7):1360-9.

Mann JF, Schmieder RE, Dyal L, McQueen MJ, Schumacher H, Pogue J, Wang X, Probstfield JL, Avezum A, Cardona-Munoz E, Dagenais GR, Diaz R, Fodor G, Maillon JM, Rydén L, Yu CM, Teo KK, Yusuf S; TRANSCEND (Telmisartan Randomised Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease) Investigators. Effect of telmisartan on renal outcomes: a randomized trial. Ann Intern Med. 2009 Jul 7;151(1):1-10, W1-2. Epub 2009 May 18.

Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators; Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet. 2008 Sep 27;372(9644):1174-83. Epub 2008 Aug 29.

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; ONTARGET investigators. 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 Aug 16;372(9638):547-53.

ONTARGET Investigators; 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 Apr 10;358(15):1547-59. Epub 2008 Mar 31.

Held C, Gerstein HC, Yusuf S, Zhao F, Hilbrich L, Anderson C, Sleight P, Teo K; ONTARGET/TRANSCEND Investigators. Glucose levels predict hospitalization for congestive heart failure in patients at high cardiovascular risk. Circulation. 2007 Mar 20;115(11):1371-5. Epub 2007 Mar 5.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00153101 History of Changes
Obsolete Identifiers:	NCT00034931
Other Study ID Numbers:	502.373
Study First Received:	September 9, 2005
Results First Received:	June 15, 2009
Last Updated:	April 11, 2011
Health Authority:	Argentina: National Administration of Medicines, Food and Medical Technology; Australia: Responsilble Ethics Committee; Austria: Ministry for Social Security and Generations; Belgium: Federal Agency for Medicines and Health Products; Brazil: National Health Surveillance Agency; Canada: Health Canada; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control (SUKL); Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: AFFSAPS; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Greece: HELLENIC REPUBLIC MINISTRY OF HEALTH AND WELFARE NATIONAL ORGANISATION OF MEDICINES (EOF); Hong Kong: Dept. of Health, Hong Kong; Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest; Ireland: The Irish Medicines Board; Italy: Comitato Etico delle Aziende Sanitarie della Regione Umbria; Korea, Republic of: Korea Food and Drug Administration (KFDA); Malaysia: Drug Control Authority; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); New Zealand: Multicentre Ethics Committee/Medsafe; Norway: Norwegian Medicines Agency (Statens Legemiddelverk); Philippines: Bureau of Pharmaceutical Affairs, Department of Health; Poland: CEBK, Warsaw; Portugal: INFARMED - National Authority of Medicines and Health Products, IP; Russia: Ministry of Health and Social Development of the Russian Federation; Singapore: Centre of Drug Administration; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; South Africa: Medicines Control Council; Spain: Ministry of Health; Sweden: Medical Product Agency; Switzerland: Swissmedic Schweizerisches Heilmittelinstitut (Swiss Agency for Therapeutic Products); Taiwan: Dept. of Health, Executive Yuan, Taiwan; Thailand: Bureau of Pharmaceutical Affairs, Department of Health; Turkey: Ministry of Health Central Ethics Committee; Ukraine: State Pharmacology Centre of the Ministry of Health of Ukraine; United Arab. Emirates: Medical Affairs Department of Health and Medical Services, General Authority Health Services, Ministry of Health for Northern Emirates; United States: Food and Drug Administration