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.

This study has been completed.

Study NCT00153101 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received: September 9, 2005 Last Updated: September 18, 2009 History of Changes

Study Type:	Interventional
Study Design:	Parallel Assignment
Condition:	Cardiovascular Diseases
Interventions:	Drug: Telmisartan Drug: Combination of Telmisartan and Ramipril Drug: Ramipril

Participant Flow

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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 [ 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 [ 56 months ]

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3. Secondary:

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

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4. Secondary:

ONTARGET. Cardiovascular Death [ 56 months ]

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5. Secondary:

ONTARGET. Non-fatal Myocardial Infarction [ 56 months ]

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6. Secondary:

ONTARGET. Non-fatal Stroke [ 56 months ]

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7. Secondary:

ONTARGET. Hospitalization for Congestive Heart Failure [ 56 months ]

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8. Secondary:

ONTARGET. Newly Diagnosed Congestive Heart Failure [ 56 months ]

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9. Secondary:

ONTARGET. Cardiovascular Revascularization Procedure [ 56 months ]

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10. Secondary:

ONTARGET. Newly Diagnosed Diabetes [ 56 months ]

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11. Secondary:

ONTARGET. Cognitive Decline [ 56 months ]

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12. Secondary:

ONTARGET. New Onset of Atrial Fibrillation [ 56 months ]

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13. Secondary:

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

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14. Secondary:

TRANSCEND. Cardiovascular Death [ 56 months ]

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15. Secondary:

TRANSCEND. Non-fatal Myocardial Infarction [ 56 months ]

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16. Secondary:

TRANSCEND. Non-fatal Stroke [ 56 months ]

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17. Secondary:

TRANSCEND. Hospitalization for Congestive Heart Failure [ 56 months ]

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18. Secondary:

TRANSCEND. Newly Diagnosed Congestive Heart Failure [ 56 months ]

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19. Secondary:

TRANSCEND. Cardiovascular Revascularization Procedure [ 56 months ]

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20. Secondary:

TRANSCEND. Newly Diagnosed Diabetes [ 56 months ]

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21. Secondary:

TRANSCEND. Cognitive Decline [ 56 months ]

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22. Secondary:

TRANSCEND. New Onset of Atrial Fibrillation [ 56 months ]

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