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Study Results
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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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
[units: participants]
 		1386 1423 1412


Statistical Analysis 1 for ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Cox
P Value [4] 0.0019
Hazard Ratio (HR) [5] 1.01
97.5% Confidence Interval ( 0.93 to 1.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin was 1.13
[3] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.8462
Hazard Ratio (HR) [4] 0.99
95% Confidence Interval ( 0.92 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Primary
Measure Title TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
[units: participants]
 		465 504


Statistical Analysis 1 for TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.2192
Hazard Ratio (HR) [4] 0.92
95% Confidence Interval ( 0.81 to 1.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the following defined endpoints, non-fatal myocardial infarction or non-fatal stroke
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
[units: participants]
 		1200 1190 1210


Statistical Analysis 1 for ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Regression, Cox
P Value [4] 0.0004
Hazard Ratio (HR) [5] 0.99
97.5% Confidence Interval ( 0.90 to 1.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin was 1.13
[3] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.9086
Hazard Ratio (HR) [4] 1.00
95% Confidence Interval ( 0.93 to 1.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   ONTARGET. Cardiovascular Death   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Cardiovascular Death
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint cardiovascular death.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Cardiovascular Death
[units: participants]
 		620 598 603


Statistical Analysis 1 for ONTARGET. Cardiovascular Death
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.9421
Hazard Ratio (HR) [4] 1.00
95% Confidence Interval ( 0.89 to 1.12 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Cardiovascular Death
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.4535
Hazard Ratio (HR) [4] 1.04
95% Confidence Interval ( 0.93 to 1.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   ONTARGET. Non-fatal Myocardial Infarction   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Non-fatal Myocardial Infarction
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Non-fatal Myocardial Infarction
[units: participants]
 		424 431 400


Statistical Analysis 1 for ONTARGET. Non-fatal Myocardial Infarction
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.2534
Hazard Ratio (HR) [4] 1.08
95% Confidence Interval ( 0.94 to 1.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Non-fatal Myocardial Infarction
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.2909
Hazard Ratio (HR) [4] 1.08
95% Confidence Interval ( 0.94 to 1.23 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   ONTARGET. Non-fatal Stroke   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Non-fatal Stroke
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint non-fatal stroke.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Non-fatal Stroke
[units: participants]
 		364 364 402


Statistical Analysis 1 for ONTARGET. Non-fatal Stroke
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.1829
Hazard Ratio (HR) [4] 0.91
95% Confidence Interval ( 0.79 to 1.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Non-fatal Stroke
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.2248
Hazard Ratio (HR) [4] 0.92
95% Confidence Interval ( 0.79 to 1.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   ONTARGET. Hospitalization for Congestive Heart Failure   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Hospitalization for Congestive Heart Failure
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint hospitalization for congestive heart failure.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Hospitalization for Congestive Heart Failure
[units: participants]
 		332 394 354


Statistical Analysis 1 for ONTARGET. Hospitalization for Congestive Heart Failure
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.1203
Hazard Ratio (HR) [4] 1.12
95% Confidence Interval ( 0.97 to 1.29 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Hospitalization for Congestive Heart Failure
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.4984
Hazard Ratio (HR) [4] 0.95
95% Confidence Interval ( 0.82 to 1.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



8.  Secondary:   ONTARGET. Newly Diagnosed Congestive Heart Failure   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Newly Diagnosed Congestive Heart Failure
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Congestive Heart failure.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Newly Diagnosed Congestive Heart Failure
[units: participants]
 		469 529 503


Statistical Analysis 1 for ONTARGET. Newly Diagnosed Congestive Heart Failure
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.3633
Hazard Ratio (HR) [4] 1.06
95% Confidence Interval ( 0.94 to 1.20 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Newly Diagnosed Congestive Heart Failure
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.3732
Hazard Ratio (HR) [4] 0.94
95% Confidence Interval ( 0.83 to 1.07 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



9.  Secondary:   ONTARGET. Cardiovascular Revascularization Procedure   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Cardiovascular Revascularization Procedure
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8502 8542 8576
ONTARGET. Cardiovascular Revascularization Procedure
[units: participants]
 		1303 1290 1269


Statistical Analysis 1 for ONTARGET. Cardiovascular Revascularization Procedure
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.5150
Hazard Ratio (HR) [4] 1.03
95% Confidence Interval ( 0.95 to 1.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Cardiovascular Revascularization Procedure
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.2713
Hazard Ratio (HR) [4] 1.04
95% Confidence Interval ( 0.97 to 1.13 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



10.  Secondary:   ONTARGET. Newly Diagnosed Diabetes   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Newly Diagnosed Diabetes
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only patients treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without baseline diabetes.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		5037 4992 5123
ONTARGET. Newly Diagnosed Diabetes
[units: participants]
 		224 277 249


Statistical Analysis 1 for ONTARGET. Newly Diagnosed Diabetes
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.1235
Hazard Ratio (HR) [4] 1.14
95% Confidence Interval ( 0.96 to 1.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects without diabetes at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Newly Diagnosed Diabetes
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.3485
Hazard Ratio (HR) [4] 0.92
95% Confidence Interval ( 0.77 to 1.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects without diabetes at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



11.  Secondary:   ONTARGET. Cognitive Decline   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. Cognitive Decline
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only patients treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		7461 7566 7602
ONTARGET. Cognitive Decline
[units: participants]
 		561 600 577


Statistical Analysis 1 for ONTARGET. Cognitive Decline
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Chi-squared
P Value [3] 0.4337
Risk Ratio (RR) [4] 1.04
95% Confidence Interval ( 0.94 to 1.17 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects with available Mini Mental State Examination (MMSE) at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. Cognitive Decline
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Chi-squared
P Value [3] 0.8690
Risk Ratio (RR) [4] 0.99
95% Confidence Interval ( 0.89 to 1.11 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects with available Mini Mental State Examination (MMSE) at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



12.  Secondary:   ONTARGET. New Onset of Atrial Fibrillation   [ 56 months ]

Measure Type Secondary
Measure Title ONTARGET. New Onset of Atrial Fibrillation
Measure Description The Ongoing Telmisartan Alone and combination with Ramipril global Endpoint trial (ONTARGET). Time to first event analysis of endpoint new onset of atrial fibrillation.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only patients treated with Telmisartan 80mg/ramipril 10mg or Telmisartan 80mg/Ramipril 10mg placebo or Ramipril 10mg/ telmisartan 80mg placebo daily for 56 months without atrial fibrillation at baseline.

Reporting Groups
  Description
Telmisartan/Ramipril (ONTARGET) No text entered.
Telmisartan (ONTARGET) No text entered.
Ramipril (ONTARGET) No text entered.

Measured Values
  Telmisartan/Ramipril (ONTARGET) Telmisartan (ONTARGET) Ramipril (ONTARGET)
Number of Participants Analyzed
[units: participants] 		8218 8259 8296
ONTARGET. New Onset of Atrial Fibrillation
[units: participants]
 		542 560 586


Statistical Analysis 1 for ONTARGET. New Onset of Atrial Fibrillation
Groups [1] Telmisartan (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.4784
Hazard Ratio (HR) [4] 0.96
95% Confidence Interval ( 0.85 to 1.08 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects without atrial fibrillation at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for ONTARGET. New Onset of Atrial Fibrillation
Groups [1] Telmisartan/Ramipril (ONTARGET) vs. Ramipril (ONTARGET)
Method [2] Regression, Cox
P Value [3] 0.2666
Hazard Ratio (HR) [4] 0.94
95% Confidence Interval ( 0.83 to 1.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  for subjects without atrial fibrillation at baseline
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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

Measure Type Secondary
Measure Title TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the following defined endpoints, Cardiovascular Death, Non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
[units: participants]
 		284 440


Statistical Analysis 1 for TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0483
Hazard Ratio (HR) [4] 0.87
95% Confidence Interval ( 0.76 to 1.00 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   TRANSCEND. Cardiovascular Death   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Cardiovascular Death
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint cardiovascular death.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Cardiovascular Death
[units: participants]
 		227 223


Statistical Analysis 1 for TRANSCEND. Cardiovascular Death
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.7764
Hazard Ratio (HR) [4] 1.03
95% Confidence Interval ( 0.85 to 1.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



15.  Secondary:   TRANSCEND. Non-fatal Myocardial Infarction   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Non-fatal Myocardial Infarction
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint non-fatal myocardial infarction.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Non-fatal Myocardial Infarction
[units: participants]
 		114 145


Statistical Analysis 1 for TRANSCEND. Non-fatal Myocardial Infarction
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0574
Hazard Ratio (HR) [4] 0.79
95% Confidence Interval ( 0.62 to 1.01 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



16.  Secondary:   TRANSCEND. Non-fatal Stroke   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Non-fatal Stroke
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Non-fatal Stroke
[units: participants]
 		112 136


Statistical Analysis 1 for TRANSCEND. Non-fatal Stroke
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.1365
Hazard Ratio (HR) [4] 0.83
95% Confidence Interval ( 0.64 to 1.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



17.  Secondary:   TRANSCEND. Hospitalization for Congestive Heart Failure   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Hospitalization for Congestive Heart Failure
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Hospitalization for Congestive Heart Failure
[units: participants]
 		134 139


Statistical Analysis 1 for TRANSCEND. Hospitalization for Congestive Heart Failure
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.6940
Hazard Ratio (HR) [4] 1.05
95% Confidence Interval ( 0.82 to 1.34 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



18.  Secondary:   TRANSCEND. Newly Diagnosed Congestive Heart Failure   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Newly Diagnosed Congestive Heart Failure
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Newly Diagnosed Congestive Heart Failure
[units: participants]
 		187 191


Statistical Analysis 1 for TRANSCEND. Newly Diagnosed Congestive Heart Failure
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.8974
Hazard Ratio (HR) [4] 0.99
95% Confidence Interval ( 0.81 to 1.21 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



19.  Secondary:   TRANSCEND. Cardiovascular Revascularization Procedure   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Cardiovascular Revascularization Procedure
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. Cardiovascular Revascularization Procedure
[units: participants]
 		351 390


Statistical Analysis 1 for TRANSCEND. Cardiovascular Revascularization Procedure
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.1431
Hazard Ratio (HR) [4] 0.90
95% Confidence Interval ( 0.78 to 1.04 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



20.  Secondary:   TRANSCEND. Newly Diagnosed Diabetes   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Newly Diagnosed Diabetes
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to the first event analysis of the endpoint Newly diagnosed Diabetes. Only calculated for those patients without diabetes at baseline.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only for patients treated with Telmisartan 80mg or Telmisartan 80mg placebo daily for 56 months without diabetes at baseline.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		1710 1751
TRANSCEND. Newly Diagnosed Diabetes
[units: participants]
 		124 165


Statistical Analysis 1 for TRANSCEND. Newly Diagnosed Diabetes
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.0172
Hazard Ratio (HR) [4] 0.75
95% Confidence Interval ( 0.60 to 0.95 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



21.  Secondary:   TRANSCEND. Cognitive Decline   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. Cognitive Decline
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND). Time to first event analysis of the endpoint cognitive decline i.e. Comparison of the Mini mental state Evaluation (MMSE) of patients at baseline with that at the 2years and end of trial. A decrease in MMSE from baseline represents a cognitive decline. This outcome measure is only available for those patients who had MMSE at baseline.
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only patients treated with Telmisartan 80mg or telmisartan 80mg placebo daily for 56 months with Mini mental state evaluation (MMSE) at baseline.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2642 2589
TRANSCEND. Cognitive Decline
[units: participants]
 		230 192


Statistical Analysis 1 for TRANSCEND. Cognitive Decline
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.0868
Risk Ratio (RR) [4] 1.17
95% Confidence Interval ( 0.98 to 1.41 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



22.  Secondary:   TRANSCEND. New Onset of Atrial Fibrillation   [ 56 months ]

Measure Type Secondary
Measure Title TRANSCEND. New Onset of Atrial Fibrillation
Measure Description Telmisartan Randomized Assessment Study in Angiotension Converting Enzyme inhibitor intolerant subjects with cardiovascular disease (TRANSCEND).
Time Frame 56 months  
Safety Issue  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Telmisartan (TRANSCEND) No text entered.
Placebo (TRANSCEND) No text entered.

Measured Values
  Telmisartan (TRANSCEND) Placebo (TRANSCEND)
Number of Participants Analyzed
[units: participants] 		2954 2972
TRANSCEND. New Onset of Atrial Fibrillation
[units: participants]
 		181 182


Statistical Analysis 1 for TRANSCEND. New Onset of Atrial Fibrillation
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] 0.9563
Hazard Ratio (HR) [4] 1.01
95% Confidence Interval ( 0.82 to 1.24 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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:
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 ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.373
Study First Received: September 9, 2005
Results First Received: June 15, 2009
Last Updated: September 18, 2009
ClinicalTrials.gov Identifier: NCT00153101     History of Changes
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





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